Comprehensive Primary Care for Adults With HIV

December 15, 2022

Purpose of This Guideline

Date of current publication: December 15, 2022
Lead authors: Mary Dyer, MD; Christine Kerr, MD
Writing group: Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: February 9, 2021

This guideline on primary care for adults with HIV was developed by the New York State Department of Health AIDS Institute (NYSDOH AI) to guide clinicians in New York State who provide primary medical care for adults (≥18 years old) with HIV.

The purpose of this guideline is to provide New York State clinicians with evidence-based clinical recommendations for provision of comprehensive primary care to patients with HIV, whether care is provided in an HIV specialty or primary care setting. The goal is to ensure that individuals with HIV in New York State can access optimal primary care in multiple outpatient clinical settings.

Note on “experienced” and “expert” HIV care providers: Throughout this guideline, when reference is made to “experienced HIV care provider” or “expert HIV care provider,” those terms are referring to the following 2017 NYSDOH AI definitions:

  • Experienced HIV care provider: Practitioners who have been accorded HIV Experienced Provider status by the American Academy of HIV Medicine or have met the HIV Medicine Association’s definition of an experienced provider are eligible for designation as an HIV Experienced Provider in New York State. Nurse practitioners and licensed midwives who provide clinical care to individuals with HIV in collaboration with a physician may be considered HIV Experienced Providers as long as all other practice agreements are met (8 NYCRR 79-5:1; 10 NYCRR 85.36; 8 NYCRR 139-6900). Physician assistants who provide clinical care to individuals with HIV under the supervision of an HIV Specialist physician may also be considered HIV Experienced Providers (10 NYCRR 94.2)
  • Expert HIV care provider: A provider with extensive experience in the management of complex patients with HIV.

At the end of 2018, there were an estimated 1,173,900 individuals ≥13 years old with HIV in the United States CDC 2020 and an estimated 108,683 in New York State NYSDOH 2019. Advances in antiretroviral therapy (ART) over the past 2 decades have significantly improved life span Gueler, et al. 2017Samji, et al. 2013Zwahlen, et al. 2009: life expectancy for a patient newly diagnosed with HIV now approaches that of an individual without a diagnosis of HIV. ART lowers rates of opportunistic infections and mortality Lundgren, et al. 2015El-Sadr, et al. 2006, and the immune system reconstitution observed with use of ART is associated with significantly improved health outcomes in patients with HIV Marin, et al. 2009Emery, et al. 2008. Clinicians should start and maintain ART in all patients with HIV.

Regardless of HIV treatment, however, when compared with individuals without HIV, those with HIV continue to have a higher risk of many comorbidities (see Box 1, below), including metabolic and infectious diseases and cancers. In one study, patients with HIV had significantly fewer morbidity-free years than patients without HIV Marcus, et al. 2020.

Box 1: Conditions With Higher Incidence in People With HIV and Selected Citations
Metabolic diseases
Infectious diseases

The increased incidence of comorbid conditions is associated with several factors, some of which are disease-specific, such as increased risks associated with ongoing immune activation Deeks, et al. 2015Deeks 2011; presumed medication-associated toxicities, such as accelerated bone density loss; length of time of HIV viremia Lang, et al. 2012; and others, such as increased rates of malignancy and hepatitis C virus (HCV) (see Box 1, above). Many of these conditions are seen regardless of immune reconstitution and HIV disease stage, and long-term HIV survivors face additional burdens from concomitant disease, medication-associated toxicity (particularly for those on or with prolonged exposure to, early antiretroviral medications), and advanced aging Maggi, et al. 2019.

Management of HIV disease in the primary care setting is similar to management of other chronic diseases, and screening for and managing comorbidities is standard for any primary care practice. This guideline offers practical recommendations and guidance for the ongoing clinical care of individuals with HIV, links to other NYSDOH AI guidelines for detailed recommendations on specific topics, and links to other helpful resources.

All patients with HIV: Regardless of viral suppression or CD4 count, HIV infection is associated with an increased risk of comorbidities related to persistent inflammation associated with the virus itself. ART clearly reduces morbidity and mortality but can also contribute to comorbidities, such as weight gain Bourgi(a), et al. 2020Bourgi(b), et al. 2020 and osteoporosis Komatsu, et al. 2018Grigsby, et al. 2010.

Patients with CD4 count <200 cells/mm3Morbidity and mortality are increased in individuals with low CD4 cell counts Castilho, et al. 2022Althoff, et al. 2019May, et al. 2016. Patients are at increased risk for morbidity and mortality if they experience unintentional weight loss or have poor functional status Siika, et al. 2018Serrano-Villar, et al. 2014. Some conditions, such as AIDS-defining malignancies, are more common in individuals with low CD4 cell counts and may be associated with markedly poor outcomes Borges, et al. 2014. See the U.S. Department of Health and Human Services Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.

Conditions related to low nadir CD4 cell count: A low nadir CD4 cell count (lowest lifetime CD4 cell count) reflects severe pretreatment immune dysfunction. Immune recovery in patients with low nadir CD4 cell counts may take longer or be less complete than in those with higher nadir CD4 cell counts Stirrup, et al. 2018Collazos, et al. 2016. Studies have found increased morbidity and mortality for 5 years after ART is initiated May, et al. 2016, and nadir CD4 cell count is a predictor of cognitive impairment and disorders Ellis, et al. 2011. Some patients may have persistently low CD4 cell counts despite achieving viral load suppression and will be at increased risk of clinical progression to AIDS-related and non-AIDS-related illnesses and death Baker, et al. 2008.

Structure and use of this guidelineThis guideline assumes that clinicians are familiar with performing a comprehensive patient history and examination and focuses on aspects of primary care that require additional attention in patients with HIV. The recommendations and supporting material in this guideline are structured as 6 sections with detailed tables (listed below) that provide specific recommendations, information, and resources on key issues to be addressed in primary care for individuals with HIV. Where appropriate, links are provided to other NYSDOH AI guidance and guidelines for more information.

For additional information on aging and HIV, see the NYSDOH AI Guidance: Addressing the Needs of Older Patients in HIV Care.

Goals of Primary Care for Adults With HIV

Patients with HIV receive care in diverse settings Cheng, et al. 2014. A patient may receive primary care from an HIV or infectious diseases specialist with a strong, disease-specific focus or may seek HIV care from a primary care provider who does not specialize in HIV care. Some studies have suggested better outcomes when patients are followed by specialists, and other studies have demonstrated contradictory findings, in that patients who are followed only by specialists may experience gaps in care, particularly with regard to identification and management of comorbidities Morales Rodriguez, et al. 2018Rhodes, et al. 2017Kerr, et al. 2012Landon, et al. 2005. Optimal care for people with HIV requires experience with both HIV and primary care.

This guideline seeks to ensure that individuals with HIV receive high-quality, comprehensive primary care in their setting of choice and provides recommendations for adult primary care for patients with HIV. The guideline is designed to support specialists in HIV care who may need additional information to provide comprehensive primary care and primary care providers who may need additional information to manage HIV-associated care.

The standard approach to primary care is the same for patients with and without HIV, whether care is delivered by a specialist or internist. An approach that is patient-centered and holistic will address the following:

  • Routine cancer screening
  • Other essential primary and secondary prevention screening (e.g., osteoporosis, heart disease)
  • Routine and HIV-specific immunizations
  • Substance use
  • Mental health disorders
  • Sexual health
  • Trauma assessment
  • Geriatric care
  • Patient education and encouragement regarding healthy lifestyle
  • Preconception counseling for those of childbearing potential

In addition to mainstays of primary care, there are unique considerations for patients with HIV, including treatment of HIV itself. Clinicians should inform patients of the benefits of antiretroviral therapy (ART) and strongly encourage patients to initiate ART as soon as possible.

Additional essential components of primary care for patients with HIV are:

  • Patient education and encouragement regarding adherence to ART to maintain viral suppression
  • Monitoring for potential long-term effects of HIV and ART, such as bone density changes, dyslipidemia, weight gain, and renal dysfunction
  • Opportunistic infection prophylaxis
  • Identification and management of comorbidities that occur more often and at younger ages in people with HIV, including atherosclerotic heart disease, non-HIV-related malignancies, renal disease, liver disease, chronic obstructive pulmonary disease, neurocognitive dysfunction, depression, and frailty (see Box 1: Conditions With Higher Incidence in People With HIV and Selected Citations). Recent studies have found that smoking and hypertension contribute significantly to morbidity, regardless of HIV-related risk factors, such as CD4 cell count or viral load Althoff, et al. 2019
  • Ongoing surveillance for diseases transmitted through the same routes as HIV, including hepatitis C virus, hepatitis B virus, human papillomavirus, and other sexually transmitted infections
  • Screening and treatment for substance use, including tobacco use
  • Ongoing discussion and patient education regarding disclosure of HIV status, principles of undetectable = untransmittable (U=U), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) for sex partners, and harm reduction strategies

Consent and confidentiality: A patient’s past medical records should be obtained whenever possible. Sharing of patient medical records among care providers who participate in health information exchanges such as the Statewide Health Information Network for New York (SHIN-NY), can facilitate information exchange (see New York eHealth Collaborative > What is the SHIN-NY?). Patients must sign a standard medical record request form (see the New York State standard consent form). Information related to HIV care can be exchanged among care providers only if a patient consents specifically to release of HIV/AIDS-related information on the standard form.

Any HIV-related patient information is confidential, and by law, care providers must maintain this confidentiality (see New York Codes, Rules, and Regulations: Part 63 – HIV/AIDS Testing, Reporting and Confidentiality of HIV-Related Information).

Stigma and medical mistrust: Among people with HIV, stigma and medical mistrust remain significant barriers to healthcare utilization, HIV diagnosis, and medication adherence and can affect disease outcomes Turan, et al. 2017Chambers, et al. 2015. Studies have found that both internalized stigma (manifested in feelings about self) and externalized stigma (enacted by others) can influence how often a patient seeks care, their engagement in care, and whether they maintain viral load suppression. Successful interventions to reduce stigma and medical mistrust include education of healthcare providers Geter, et al. 2018, peer support Flórez, et al. 2017, and social support Rao, et al. 2018.

Case management: The goal of comprehensive case management is to improve patient outcomes and retention in care by providing the support and resources of a healthcare team that includes the clinical care provider. Comprehensive case management connects patients to community resources and can improve engagement with medical care, including screening and management of comorbid conditions, and HIV-specific outcomes, such as immune reconstitution Brennan-Ing, et al. 2016.

Case management has been shown to dramatically improve viral load suppression among individuals who inject drugs or smoke crack cocaine, 2 groups who are difficult to retain in care. One study showed an increase in viral load suppression from 32% to 74% and another showed a mortality benefit from case management intervention Kral, et al. 2018Miller, et al. 2018.

Peer support: Peer support can provide an individual with emotional and practical guidance from someone with shared life experience and can be a tool to reduce stigma. Peer support has been found to improve retention in care Cabral, et al. 2018 and improved viral suppression in a group of individuals with HIV who were recently incarcerated Cunningham, et al. 2018. However, data for the general population are inconclusive regarding the effects of peer interventions on viral load suppression or other outcomes, and more research is needed Giordano, et al. 2016Metsch, et al. 2016.

History, Assessment, and Evaluation: Initial, Ongoing, and Annual

History, Assessment, and Evaluation

History-taking for patients with HIV requires attention to all of the elements standard in primary care while including several additional elements, which are detailed in Table 1, below. It is essential to identify, assess, and monitor HIV- and antiretroviral therapy (ART)-related complications and other HIV-specific comorbidities (see Box 1: Conditions With Higher Incidence in People With HIV and Selected Citations).

A comprehensive baseline history includes sexual health, mental health, substance use (including illicit use of prescription drugs), and social history. Patients may choose not to disclose all pertinent personal information during the first visit, but a sympathetic and nonjudgmental attitude can help establish trust and facilitate further discussion and disclosure during subsequent visits.

Anatomical inventory: In addition to all elements of a standard patient history and physical examination, it is important for clinicians to perform an anatomical inventory and determine primary care needs based on which organs are present rather than on the gender expression of the patient. A matter-of-fact anatomical inventory will identify present and absent organs: penis, testes, prostate, breasts, vagina, cervix, uterus, and ovaries.

HIV-Specific Medical History

Essential components of an HIV-specific medical history are detailed in this section and in Table 1, below. Confirmation of a patient’s HIV infection should include documented laboratory testing results. If results are not available, baseline testing should be performed as noted in Table 1, below. If a patient was recently diagnosed with HIV, discussion of the reasons for testing and the route of exposure will assist the clinician in identifying appropriate goals for risk reduction education, counseling, and intervention, which may include ongoing screening for sexually transmitted infections (STIs).

Essential components of an HIV-specific medical history:

  • Viral load and CD4 cell count at diagnosis, if known
  • Patient circumstances at time of diagnosis (housing, employment, food security, relationship status, etc.)
  • ART history, including previous regimens, reasons for any changes in prior regimens, and any adverse effects
  • Pauses in ART and lapses in adherence
  • Previous resistance testing results
  • History of opportunistic infections
  • History of HIV-related hospitalization(s)
  • Disclosure status (whether partners, family, or friends are aware of HIV status) and partner notification
  • History of other STIs with shared risk factors, including hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Ongoing high-risk behaviors for transmission of HIV and acquisition of STIs or infections associated with injection drug use
  • Experience of stigma and social support

ART history: Essential elements of an ART history include all previous medications, why they were stopped, and reasons for stopping (e.g., allergies, adverse effects, pill-taking fatigue or discomfort, and drug resistance). Understanding these reasons and seeking ways to simplify ART regimens or reduce pill burden will support a therapeutic alliance around adherence going forward.

ART initiation: If a patient with HIV has not yet started ART, it should be initiated as soon as appropriate and possible, and any barriers to ART initiation should be assessed so support can be provided.

Trauma-informed care: A trauma-informed approach to care is important to mitigate any medical trauma, such as frightening experiences or stigma associated with the initial HIV diagnosis Tang, et al. 2020Sherr, et al. 2011. See the following for more information:

Adherence: For patients already taking ART, assessing adherence and providing support for optimal adherence are crucial and should include careful assessment of adverse medication effects, which often lead to adherence problems or medication cessation. Other factors to discuss that may pose barriers to adherence include insurance coverage, housing instability, disclosure status, substance use, and mental health.

Viral hepatitis status: Many of the risk factors for acquisition of viral hepatitis are the same as those for HIV. Assessment of a patient’s viral hepatitis status, including a history of viral hepatitis infection and treatment, helps clinicians determine optimal treatment options. In individuals with HIV, progression of HBV- or HCV-associated liver fibrosis, cirrhosis, cancer, portal hypertension, and encephalopathy is more rapid than in those without HIV Weber, et al. 2006Thio, et al. 2002Graham, et al. 2001Benhamou, et al. 1999.

HCV: Because the risk of severe liver disease is increased in patients with HIV Soti, et al. 2018, all patients with HCV and HIV should be treated for HCV infection as soon as possible. Potential interactions between ART and HCV medications should be identified and addressed. Treatment of chronic HCV is the same for individuals with and without HIV.

HBV: A history of HBV infection will influence HIV medication choice and requires attention to drug-drug interactions. Because tenofovir, emtricitabine, and lamivudine are effective against both HBV and HIV, it is important to assess baseline HBV status and choose combination HIV therapy to appropriately treat the HBV infection as well as HIV. It is also important to appropriately monitor for progression of fibrosis or hepatocellular carcinoma; however, ART initiation should not be delayed pending evaluation of HBV status and liver damage. See the NYSDOH AI guideline Prevention and Management of Hepatitis B Virus Infection in Adults With HIV.

General Medical Status, History, and Physical Examination

This guideline assumes that care providers are familiar with performing a comprehensive physical examination. Several areas may require additional attention because the incidence, associated complications, or severity may be increased in individuals with HIV or low CD4 cell counts.

Medications: Ideally, a complete medication history should be acquired at baseline and updated as needed during future visits. A detailed medication history (with emphasis on ART) allows the clinician to identify possible adverse drug-drug interactions between ART and medications the patient is taking to treat comorbidities (see Box 1: Conditions With Higher Incidence in People With HIV and Selected Citations). Patients with HIV may have multiple comorbidities due to infection and related inflammatory processes or the effects of medications. Examination of a patient’s current medical status and medication regimen may identify the need for changes in the ART regimen, changes in medications prescribed for other medical conditions, options for simplification of medication regimens, and medications that may be discontinued (see the NYSDOH AI guideline Selecting an Initial ART Regimen > Special Considerations for Comorbid Conditions).


Metabolic changes: There are significant metabolic concerns for people with HIV and AIDS Mankal and Kotler 2014. Weight gain often occurs after initiation of ART. Assessing weight loss or gain at every visit will assist with early identification of metabolic changes Bourgi(b), et al. 2020. Female gender, Black race, pre-ART CD4 cell count depletion, and lower pre-ART body mass index have been associated with >10% weight gain at 2 years after ART initiation Bourgi(b), et al. 2020. Integrase strand transfer inhibitors (dolutegravir, bictegravir, raltegravir, elvitegravir, and cabotegravir) have been associated with greater weight gain than non-nucleoside reverse transcriptase inhibitors or protease inhibitors, particularly when used in combination with tenofovir alafenamide Sax, et al. 2020. Weight loss is more common in individuals with low CD4 cell counts and may prompt investigation of malignancy, infection, and psychosocial instability.

Head, eyes, ears, nose, and throat: An ophthalmologic examination at baseline and at least annually thereafter is indicated for patients with a CD4 count <50 cells/mm3. Cytomegalovirus (CMV) infection can lead to retinitis, vision loss, and death. Varicella zoster virus and herpesvirus infections can lead to retinitis and retinal necrosis Nakamoto, et al. 2004. After the introduction of highly active ART, the 10-year cumulative incidence for CMV retinitis was 33.6% for individuals with CD4 counts <50 cells/mm3 and 4.2% for those with CD4 counts <200 cells/mm3 Sugar, et al. 2012. Icterus may be present in individuals who are taking atazanavir as part of their ART regimen by causing a benign hyperbilirubinemia Bertz, et al. 2013. HIV viremia can also lead to a direct retinopathy at high viral loads and low CD4 cell counts Jabs 1995.

Although HIV infection itself does not increase the likelihood of viral upper respiratory infections, symptoms such as cough, sinusitis, and otitis are common in patients with HIV Brown, et al. 2017Chiarella and Grammer 2017Small and Rosenstreich 1997. Because sinusitis and otitis can present without significant facial pain or discomfort in patients with CD4 counts <50 cells/mm3, it is reasonable to perform imaging and evaluate for infection with atypical organisms, such as fungal sinusitis, more readily in these patients.

People with HIV also have a higher risk of oral malignancies than those without HIV, and those with low CD4 cell counts may have diverse oropharyngeal findings, including oral Kaposi sarcoma, oral candidiasis, human papillomavirus (HPV)- and HIV-related parotitis, and necrotizing gingivitis, requiring evaluation during in-person examinations Trevillyan, et al. 2018Sorensen 2011Epstein 2007. Clinicians should encourage patients to have annual dental examinations (see National Institute of Dental and Craniofacial Research > HIV/AIDS & Oral Health).

Heme/lymph: Lymphadenopathy may occur at any stage of HIV disease, does not always correlate with disease progression or prognosis, and may be less pronounced in older patients. However, widespread, firm, or asymmetrical lymphadenopathy requires prompt consideration of lymphoma, syphilis, tuberculosis (TB), mycobacterium avium-intracellulare infection, and lymphogranuloma venereum, all of which can occur regardless of CD4 cell count but are more likely at lower CD4 cell counts. Nonadherence to ART may also be considered.

Diffuse large B-cell lymphoma, Burkitt lymphoma, and primary central nervous system lymphoma are AIDS-defining conditions; lymphoproliferative diseases, such as Castleman disease, should be considered as well. Any evidence of lymph nodes larger than 1 cm or evidence of fixed, matted, or hard nodes should prompt consideration for biopsy, particularly if a patient has a low CD4 cell count.

Dermatologic: An annual comprehensive skin examination ensures that concerns are identified early. Regardless of CD4 cell count, findings such as shingles and psoriasis are more frequent in people with HIV than in those without HIV Alpalhão, et al. 2019Erdmann, et al. 2018. For more information, see National HIV Curriculum > Cutaneous Manifestations.

Attention should be paid to any dermatologic history, such as a history of skin cancers and recurrent rash, which could be consistent with psoriasis, seborrheic dermatitis, atopic dermatitis, eosinophilic folliculitis, or secondary syphilis Alpalhão, et al. 2019Green, et al. 1996. Symptoms can overlap and coexist.

Less common diseases, such as Kaposi sarcoma, eosinophilic folliculitis, disseminated zoster, molluscum contagiosum, and cutaneous HPV, may occur in patients with low CD4 cell counts. Familiarity with these diseases is important.

Neurologic: As noted in Table 1, below, clinicians should examine patients’ neurologic and cognitive function at baseline, at least annually for those at risk (due to low CD4 cell count, age, or comorbidities) and more often if there are patient or family concerns. Several standardized tests are available, including the MoCA Test (requires an account), Mini-Cogand Mini-Mental State Examination (MMSE).

Compared with patients who have higher CD4 cell counts, patients with low CD4 cell counts may be at increased risk for neurologic conditions, which can include rare diseases, such as progressive multifocal leukoencephalopathy, HIV-associated neurologic disease, toxoplasmosis, and cryptococcal meningitis, and common diseases with atypical presentation, such as syphilis and TB.

Imaging and diagnostic work-up are warranted for new or persistent neurologic symptoms (e.g., seizure, changes in mental status, or persistent headache) regardless of CD4 cell count, but especially in patients with a low CD4 cell count.

Respiratory: Clinicians should perform a lung examination at baseline and at least annually, or more often if indicated. Community-acquired pneumonia is more common in people with HIV, regardless of CD4 cell count, than in those without HIV Almeida and Boattini 2017, as is chronic obstructive pulmonary disease Bigna, et al. 2018. Chronic lung disease is increasingly common among older people with HIV, among smokers, and among those who have had Pneumocystis jiroveci pneumonia (PJP; formerly known as Pneumocystis carinii pneumonia or PCP), who may have residual blebs that can lead to pneumothorax Risso, et al. 2017.

In patients with low CD4 cell counts who have respiratory examination findings or symptoms, clinicians should perform a chest radiographic or computerized tomography to evaluate for infection or neoplasm Yee, et al. 2020. Clinicians should also maintain a low threshold for suspicion of TB and pursue appropriate diagnostic and public health measures if TB is suspected.

Comorbidities: For patients with comorbidities, such as cardiovascular disease, lung disease, renal disease, diabetes mellitus, and malignancies, personal and family history should be collected, and individual risk factors should be discussed. Because HIV has been associated with increased risk and accelerated disease process for these comorbidities, care providers should be sure to discuss appropriate screening and have a low threshold for diagnostic testing referral if symptoms develop Kaspar and Sterling 2017Triant 2013Islam, et al. 2012Shiels, et al. 2011Bower, et al. 2009Crothers, et al. 2006. In individuals taking ART, risk factors such as smoking and hypertension cause more morbidity and mortality than HIV-specific risk factors, such as low CD4 cell count Althoff, et al. 2019Trickey, et al. 2016Helleberg, et al. 2015.

History of particular comorbidities may also influence medication choice for those starting ART. For example, patients with a history of metabolic disease may wish to avoid protease inhibitors because of the association with central obesity, and patients with risk factors for significant renal disease may wish to avoid tenofovir disoproxil fumarate. If patients do have significant risk for and are taking ART or other medications that can affect these conditions, more frequent monitoring may be warranted Crum-Cianflone, et al. 2010. Nonalcoholic steatohepatitis is observed in 30% to 40% of people with HIV Kaspar and Sterling 2017 and may affect both monitoring and medication choice.

Endocrine conditions, such as metabolic syndrome, insulin resistance, dyslipidemia, lipodystrophy, and osteoporosis, may be worsened by certain antiretroviral medications. A full medication history will help clinicians identify the possibility of ART-associated contribution to these conditions Noubissi, et al. 2018Gazzaruso, et al. 2003. Because thyroid disease and hypogonadism occur more often in people with HIV than in those without, a low threshold for screening for these conditions is appropriate.

Aging: As the population living with HIV ages, frailty, functional, and cognitive assessments are essential. Baseline discussion of memory loss, neuropathic symptoms, and chronic pain can help identify conditions that may affect ART adherence. Nadir CD4 cell count is a predictor of cognitive impairment and disorders Ellis, et al. 2011. Collecting structured data through use of standardized assessments will help clinicians to determine illness course; standardized assessment tools include the MoCA Cognitive AssessmentMini-Cog, and MMSE, as noted above. An annual assessment of functional status is also indicated.

Psychosocial status: Baseline and annual psychosocial assessments, as described in Table 2, below, include a detailed sexual, trauma, substance use, and psychiatric history; more frequent assessment may be required for patients who require follow-up in any area. Care providers, particularly those new to HIV care, may initially feel uncomfortable conducting these assessments. Resources are provided below for structured assessments; a team approach when possible may be helpful and allow for incorporation of multidisciplinary assessments, including those of a case manager and clinical social worker.

Sexual health: Discussion of sexual health, including a patient’s history of STIs, is an important component of the baseline and annual assessments and is an opportunity to discuss a patient’s concerns and questions. The frequency of the sexual health assessment is based on risk factors. It is particularly important to use nonjudgmental, sex-positive language in this discussion to establish a strong connection and facilitate open discussion. Discussion of U=U (undetectable = untransmittable) in the clinical setting can facilitate reduction of stigma and discussion of important considerations in sexual health.

Reproductive status: Clinicians should ascertain reproductive history and goals with all patients and address contraception and plans for conception with patients of childbearing potential. Patients wishing to have children should be supported and provided with information on current strategies to eliminate perinatal HIV transmission. Risk of perinatal transmission is less than 1% when patients are virally suppressed and with informed management of the perinatal period Ioannidis, et al. 2001. For patients who are pregnant or planning pregnancy, care providers should discuss appropriate preconception planning, including folate use, medication safety, and plans for breastfeeding, as well as the risk to a partner without HIV if the patient has a detectable viral load. Education about HIV pre-exposure prophylaxis should be provided when indicated.

Menopause, whether natural or surgical, has been associated with increased fatigue and muscle aches or pains in people with HIV Schnall, et al. 2018.

Guide to the tables below: Although the tables below are comprehensive in scope, this committee supports a flexible approach in using this guide to determine elements that should be included in a comprehensive initial history and physical examination. All aspects of the patient history and physical examination do not have to be covered in a single visit or by the primary care clinician. For some care providers and patients, the best approach may be to spend 2 or more visits completing the initial assessment and address some aspects of the history and physical examination during follow-up visits.

Abbreviations: ART, antiretroviral therapy; CDC, Centers for Disease Control and Prevention; COPD, chronic obstructive pulmonary disease; CVD, cardiovascular disease; GI, gastrointestinal; HAV, hepatitis A virus; HBV, hepatitis B virus; HCV, hepatitis C virus; MMSE, Mini-Mental State Examination; NYSDOH AI, New York State Department of Health AIDS Institute; OI, opportunistic infection; TB, tuberculosis; U=U, undetectable = untransmittable; USDA, United States Department of Agriculture; WPATH, World Professional Association for Transgender Health.
Table 1: HIV, Medications, and General Medical Status and History for Adults With HIV
*Frequency Key: I = initial (baseline) visit; A = annual visit; E = every visit
Assessment To Include Frequency*
Current HIV-Specific Status and History
Antiretroviral therapy
  • Date of ART initiation
  • Current ART regimen
  • Previous ART regimens and reasons for any changes in regimens
  • History of drug resistance, if known
  • Adverse effects
  • Current adherence status and challenges
  • Knowledge of U=U
  • If ART has not been initiated, see NYSDOH AI guideline Rapid ART Initiation.
Viral load
  • Most recent viral load
  • Peak viral load
CD4 cell count
  • Most recent CD4 cell count
  • Nadir CD4 cell count
AIDS-defining conditions
  • Previous diagnoses and treatments
  • History of malignancies and treatments
  • Investigation of symptoms such as weight loss, night sweats, or chronic cough
Opportunistic infections
  • Previous OI prophylaxis
  • Previous diagnoses and treatment, including latent TB infection
  • Adverse reactions to medications for OI prophylaxis or treatment
Current Medications
Complete medication list
  • All medications: prescribed, over-the-counter, herbal preparations; include nonpharmacologic agents
  • Potential drug-drug interactions
  • Adverse effects
  • Challenges with adherence to prescribed medications
Current General Medical Status and History
  • History of immunizations
  • Status of HIV- and age-related preventive immunizations
Age-related disease screening
  • Results of previous age-related disease screening tests
  • History of cardiac events, stroke, and treatment
  • History of hypertension
  • History of diabetes or insulin resistance
  • Risk factors for CVD
  • Family history of CVD
  • History of COPD and treatment
  • Current tobacco/vape use and smoking history
  • History of prior malignancies and treatment
  • Previous age-appropriate screening and results
  • Family history of malignancies
  • History of renal disease and treatment
  • Consider ART history
  • Consider associated comorbidities
  • History of and treatment for viral hepatitis (HAV, HBV, or HCV)
  • Adverse reactions to medications
  • Risk factors for nonalcoholic steatohepatitis
  • Past alcohol use
  • Current alcohol use
  • Symptoms of thyroid dysfunction or hypogonadism
  • Sexual dysfunction
  • Weight loss or weight gain
  • Family history of metabolic syndrome and thyroid disease
  • History of osteoporosis and treatment, fractures, and previous screening
  • History of lipodystrophy and treatment
  • Use of hormonal therapy (including treatments obtained without prescription)
  • Current and previous ART use, which may contribute to metabolic syndrome, lipodystrophy, and insulin resistance
  • History of GI disease and treatment
  • GI-related adverse effects of medications and effect (if any) on adherence to prescribed medications
  • Family history of GI disease
  • Changes in vision, including blurry vision, double vision, flashes of light, loss of vision, use of glasses, and blindness or legal blindness
  • Changes in hearing
  • Recent audiology testing or new hearing aid use
  • History of neurocognitive assessment and results
  • Assessment of current neurocognitive status, preferably using standardized tools such as the MoCA Test (requires an account), Mini-Cog, or MMSE
  • History of neuropathy and treatment
  • Assessment of symmetric distal polyneuropathy, which is common, particularly in patients exposed to earlier generations of ART
  • History of psoriasis and treatment
  • History of seborrheic dermatitis and treatment
  • History of atopic dermatitis and xerosis and treatment
  • History of skin cancer and treatment
  • Note: Dermatitis can worsen with degree and duration of immunosuppression.
Surgery I A
Pain I E
  • History of chronic obstructive sleep apnea and treatment
  • History of sleep disturbances and treatment
Nutrition I E
Frailty I A
  • Recent travel; assess for potential exposure to infectious disease
  • Frequency and location of international travel (work or leisure)
  • Status of travel-related immunizations
  • Lifetime travel history, if indicated
  • Current and past pet ownership, including exotic animals
  • History of zoonotic diseases and treatment

Download Table 1: HIV, Medications, and General Medical Status and History for Adults With HIV Printable PDF

Abbreviations: ADAP, AIDS Drug Assistance Program; ART, antiretroviral therapy; CDC, Centers for Disease Control and Prevention; C-SSRS, Columbia-Suicide Severity Rating Scale; NYSDOH AI, New York State Department of Health AIDS Institute; PHQ, Patient Health Questionnaire; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection; U=U, undetectable = untransmittable; USPSTF, U.S. Preventive Services Task Force.
Table 2: Psychosocial, Behavioral Health, Sexual Health, and Well-Being Assessment of Adults With HIV
*Frequency Key: I = initial (baseline) visit; A = annual visit; N = as needed
Assessment To Include Frequency*
Gender and Sexual Identity
Gender identity
  • Current gender identity and sex assigned at birth
  • Pronouns
Current sexual identity
  • History of sexual identity
Gender transition
  • Gender transition goals; successes and challenges
  • History of, planned, or desired gender-affirming surgery
  • Current, past, or planned use of gender-affirming hormones
  • Source of gender-affirming hormones
  • Adverse effects of gender-affirming treatments
Inventory of sexual organs
  • Presence or absence of penis, testes, prostate, breasts, vagina, cervix, uterus, and ovaries; determination of patient’s preferred terms for body parts
Current Psychosocial Status and History
  • Housing stability or connection to resources if housing is unstable
  • Relocation plans
  • Monitor for signs of housing instability.
Family and other significant relationships and responsibilities
  • Immediate and extended family members as defined by the patient
  • Significant relationships
  • HIV disclosure status
  • Financial and care-giving dependents, including children, spouse or life partner, aging parents, and extended or chosen family members
  • Community support, including functional needs and agency or family assistance
  • Transportation
  • Pets in home
  • Monitor for signs of instability.
Interpersonal and social support network
  • Members of the patient’s primary interpersonal and social support network
  • People to whom the patient has disclosed their HIV status
  • Discussion of experienced and perceived stigma
  • Monitor for signs of instability.
  • Current employment status or employment goals
  • Access to financial support if unemployed or under-employed
  • Employment-associated risks to health or well-being, including stigma and discrimination
Medical insurance
  • Access to private medical insurance, Medicaid, ADAP, or Medicare
  • Prescription coverage
  • Hospitalization coverage
  • Access to resources for coverage if uninsured (see NYSDOH Uninsured Care Programs)
  • History of incarceration
  • Probation, parole, and other legal status
End-of-life planning
  • Documented healthcare proxy
  • Documented preferences for end-of-life care and living will
  • Long-term care plans
Current Mental Health Status and History
Mental illness
  • History of mental illness and treatment
  • Adverse reactions to medications
  • History of psychiatric hospitalization
  • Suicide risk assessment and past history of suicide attempts
  • Family history
  • See USPSTF: Screening for Depression in Adults (2016); assess mental health using standardized tools, such as the PHQ-2PHQ-9, and C-SSRS.
  • History of trauma, including domestic violence; physical, verbal, sexual, or emotional abuse; or witnessed trauma
  • History or current experience of elder abuse
  • Any effects on current function and coping strategies
  • Current major stressors
  • Stress management and coping skills
  • Current experience or history of HIV-associated or other stigmas
Current Substance Use and History
  • History of use, including use disorder diagnosis and treatment
  • Adverse reactions to medications
  • Screening for current use, and if indicated, risk assessment using standardized tools
  • If indicated, implementation of a harm reduction treatment plan
Tobacco use and vaping
  • Current level of tobacco use and type; smoking prevalence is high in people with HIV Pacek and Cioe 2015
  • History of use and prior treatment
  • Adverse reactions to medications
Use of nonprescription drugs and misuse of prescribed drugs
  • All types of drug use, including misused prescription medications
  • History of use, including use disorder diagnosis and treatment
  • Route of use
  • History of overdose
  • Screening for current use, and if indicated, risk assessment using standardized tools
  • If indicated, implementation of a harm reduction treatment plan
Sexual and Reproductive Health and History
Sex partner(s) and activity I A N
Sexually transmitted infections
  • History of and treatment for syphilis, gonorrhea, chlamydia, human papillomavirus, and other STIs
  • Source of prior treatment for any STI
  • Assessment of ongoing risk factors, and if indicated, implementation of harm or risk reduction plan; use of condoms or other barrier protection
  • Screening of all potentially exposed sites (see CDC Sexually Transmitted Infections Treatment Guidelines, 2021 > Screening Recommendations for evidence-based recommendations)
Reproductive history
  • Offspring
  • Previous failed attempts at reproduction
  • Previous treatment for reproductive issues and source
  • Adverse effects
  • Contraceptive history
  • Previous abortion(s)
Reproductive goals
  • Family planning goals
  • Contraception use and options
  • Possible drug-drug interactions for individuals taking ART

Download Table 2: Psychosocial, Behavioral Health, Sexual Health, and Well-Being Assessment of Adults With HIV Printable PDF

Laboratory and Diagnostic Testing

Table 3, below, outlines recommended laboratory testing for adults with HIV.

Abbreviations: anti-HBs, hepatitis B surface antibody; ART, antiretroviral therapy; CDC, Centers for Disease Control and Prevention; MSM, men who have sex with men; CVD, cardiovascular disease; DHHS, U.S. Department of Health and Human Services; FDA, U.S. Food and Drug Administration; G6PD, glucose-6-phosphate dehydrogenase; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCV, hepatitis C virus; IGRA, interferon-gamma release assay; MSM, men who have sex with men; NYSDOH AI, New York State Department of Health AIDS Institute; PPD, purified protein derivative; TB, tuberculosis; TDF, tenofovir disoproxil fumarate; TGW, transgender women; USPSTF, U.S. Preventive Services Task Force; UTI, urinary tract infection.
Table 3: Recommended Laboratory Testing for Adults With HIV
*Frequency Key: I = initial (baseline) visit; A = annual visit; N = as needed
Laboratory Test Comments Frequency*
HIV-1 RNA quantitative viral load
  • Regular monitoring is the most accurate and meaningful measure of effective ART.
  • Check every 3 to 6 months during years 1 and 2, and every 4 to 6 months thereafter.
  • Monitor every 1 to 3 months if adherence is unstable or patient has detectable viral load.
CD4 lymphocyte count
  • Check every 3 to 6 months if CD4 count <200 cells/mm3; not indicated if viral load is consistently undetectable (CD4 count ≥200 cells/mm3).
  • Monitor every 3 months if diagnosis is recent (<2 years), viral load suppression is inconsistent, or CD4 count is close to or below 200 cells/mm3.
  • See NYSDOH AI guideline Virologic and Immunologic Monitoring in HIV Care.
HIV-1 resistance testing (genotypic)
  • Perform at treatment initiation.
  • Perform if HIV RNA (viral load) is ≥500 copies/mL; archive genotype may be considered if viral load is <500 copies/mL.
  • Consult with an expert in HIV care in the event of treatment failure.
  • Screen for deficiency to avoid use of oxidant drugs, including dapsone, primaquine, sulfonamides.
  • Prevalence of G6PD deficiency is highest among people of African, Asian, or Mediterranean descent, but consider in all patients given diversity of backgrounds.
Complete blood count
  • For patients not taking zidovudine, check at initiation of ART and repeat as clinically indicated.
  • For patients taking zidovudine, check at initiation and 4 weeks after initiation; follow every 3 months for the first year, then every 6 months.
  • Consider with any change in medication.
Estimated glomerular filtration rate
  • For patients taking TDF, check at initiation, then repeat at 4 weeks, 3 months, 6 months, and 12 months for the first year, then every 6 months thereafter.
  • For patients not taking TDF, check at initiation, at 6 months during the first year, then annually thereafter.
  • Check after initiation of medication with risk for renal disease (e.g., use of nonsteroidal anti-inflammatory agents, angiotensin-converting enzyme inhibitors).
  • Check if patient has history of diabetes or other renal diseases.
Hepatic panel:

  • Aspartate aminotransferase
  • Alanine aminotransferase
  • Alkaline phosphatase
  • Total bilirubin
  • Check 3 months after initiation of ART, after initiating medication with risk for liver disease (e.g., statins, azoles), or if there is a history of viral hepatitis, and then at 12 months.
  • Check every year if patient is stable and without above risks.
Random blood glucose (fasting or hemoglobin A1C if high) I A N
Tuberculosis screening I A
Hepatitis A

  • Anti-hepatitis A immunoglobulin
Hepatitis B

  • Surface antibody
  • Surface antigen
  • Core antibody
Hepatitis C

  • HCV antibody
  • HCV RNA quantitative viral load
Measles titer
  • Vaccinate if patient is not immune and has a CD4 count >200 cells/mm3.
Varicella titer
  • For patients with no evidence of immunity and CD4 count >200 cells/mm3, consider vaccination for chicken pox (Varivax; 2 doses, 3 months apart); engage patients in shared decision-making, taking into consideration the potential risks of a live vaccine.
  • Live vaccines are contraindicated for patients with CD4 counts <200 cells/mm3.
  • For patients ≥50 years old, regardless of varicella titer status or CD4 cell count, consider vaccination for herpes zoster with recombinant zoster virus (Shingrix; 2 doses, 2 to 6 months apart).
Urinalysis I A N
Urine pregnancy test
  • Perform for all individuals of childbearing potential who are sexually active.
  • Repeat at patient request.
Lipid panel
  • Perform at least every 3 years if patient has increased risk for CVD.
  • Consider annual screening if patient is taking protease inhibitors.
  • For adults >75 years old, initiate discussion of possible benefits of age-appropriate preventive therapies in the context of comorbidities and life expectancy.
  • HIV is considered a risk-enhancing factor for CVD; clinicians may opt to perform more frequent lipid testing in patients with cardiovascular comorbidities.
I +/- N
Serum thyroid-stimulating hormone
  • Insufficient evidence exists for routine screening of nonpregnant adults.
  • Adults with HIV have higher incidence of thyroid dysfunction than those without HIV. Discuss annual screening. See USPSTF Thyroid Dysfunction: Screening.
I +/-
Gonorrhea and chlamydia I A N
Syphilis I A N
  • Perform screening test if the patient has a vagina and is sexually active.
  • Must be performed before initiation of abacavir, otherwise not routine.

Download Table 3: Recommended Laboratory Testing for Adults With HIV Printable PDF

Routine Screening and Primary Prevention

Routine Screening and Primary Prevention
  • For adults with HIV who are seen for primary care, clinicians should provide:
  • Clinicians and patients should engage in shared decision-making regarding routine health screening tests, weighing the risks and benefits of screening based on such factors as life expectancy, cost, potential harms, and HIV-compounded risk. (A3)

Prevention is the cornerstone of primary care and is mostly the same for patients with and without HIV. Tables 4 and 5, below, provide links to standard screening guidelines, some of which are specific to HIV.

Abbreviations: CDC, Centers for Disease Control and Prevention; MSM, men who have sex with men; NYSDOH AI, New York State Department of Health AIDS Institute; USPSTF, U.S. Preventive Services Task Force.


  1. An anatomical inventory is necessary to identify appropriate sex-based screening.
  2. If no NYSDOH AI guideline is available, the relevant USPSTF guideline is included; the USPSTF guidelines are comprehensive and evidence-based.
  3. Screening recommendations are the same for individuals with HIV and without HIV.
Table 4: Routine Screening for Adults With HIV
Type of Screening [a] Recommended Guideline(s) [b] Age of Screening Initiation, Frequency, and Comments
Breast cancer [c]
  • Discuss screening with patients who are 50 to 75 years old every 2 years.
  • Evidence of benefit is insufficient for patients who are >75 years old.
  • Begin screening as early as age 40 years for patients with family history of breast cancer (parent, sibling, or child).
Colon cancer [c] USPSTF: Colorectal Cancer: Screening (2021)
  • Screen patients who are 45 to 75 years old: frequency depends on screening method. Confirm annually that appropriate testing has been completed.
  • In patients who are >75 years old, the decision to perform screening should be individualized.
Cervical cancer [c] NYSDOH AI: Screening for Cervical Dysplasia and Cancer in Adults With HIV (2022)
  • Begin screening at 21 years old or within 2 years of onset of sexual activity.
  • Continue screening for patients ≥65 years old; however, consider life expectancy and risk in shared decision-making with patient regarding continued screening.
  • Recommendations for cervical cancer screening in patients with HIV are not the same as those for people who do not have HIV.
Anal dysplasia and cancer NYSDOH AI: Screening for Anal Dysplasia and Cancer in Patients With HIV (2022)
  • Screen MSM, cisgender women, transgender women, and transgender men who are ≥35 years old.
  • Engage younger patients in shared decision-making regarding screening or deferral until age 35 years.
  • Recommendations for anal cancer screening in patients with HIV are not the same as those for people who do not have HIV.
Lung cancer [c] USPSTF: Lung Cancer: Screening (2021)
  • Screen patients who are 55 to 80 years old who have a 20 pack-year history and currently smoke or have quit within the past 15 years.
Prostate cancer [c] USPSTF: Prostate Cancer: Screening (2018)
  • In patients who are 55 to 69 years old, the decision to perform screening should be individualized.
  • Engage in shared decision-making for patients who are ≥70 years old.
Bone density USPSTF: Osteoporosis to Prevent Fractures: Screening (2018)
Abdominal aortic aneurysm USPSTF: Abdominal Aortic Aneurysm: Screening (2019)
  • Screen cisgender men and transgender women who are 65 to 75 years old who have ever smoked.
  • There is insufficient evidence for or against screening in cisgender women and transgender men who have ever smoked.

Download Table 4: Routine Screening for Adults With HIV Printable PDF

Abbreviations: ASCVD, atherosclerotic cardiovascular disease; C-SSRS, Columbia-Suicide Severity Rating Scale; FDA, U.S. Food and Drug Administration; NYSDOH AI, New York State Department of Health AIDS Institute; PHQ, Patient Health Questionnaire; USPSTF, U.S. Preventive Services Task Force
Table 5: Primary Prevention for Adults With HIV
Type Recommended Guideline(s) Comments
Tobacco smoking USPSTF: Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions (2021)
Unhealthy alcohol and drug use NYSDOH AI: Substance Use Screening, Risk Assessment, and Use Disorder Diagnosis in Adults (2024)
Cardiovascular disease USPSTF:


Depression USPSTF: Screening for Depression in Adults (2016)
  • USPSTF: Screen for depression, with adequate systems in place to ensure accurate diagnosis, effective treatment, and appropriate follow-up.
  • Resources:
Domestic violence USPSTF: Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening (2018)
  • Screen for domestic violence, including intimate partner violence, child abuse, and elder abuse.
Sexually transmitted infections USPSTF: Sexually Transmitted Infections: Behavioral Counseling (2020)
  • USPSTF: Provide behavioral counseling for all sexually active adults and adolescents.
  • Include discussion of appropriate vaccinations.
Neural tube defects in pregnancy USPSTF: Folic Acid for the Prevention of Neural Tube Defects: Preventive Medication (2017)
  • USPSTF: Folic acid supplementation is recommended for individuals who are planning or capable of pregnancy.
Breast cancer USPSTF: Breast Cancer: Medication Use to Reduce Risk (2019)
    • Risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors are recommended for women who are at increased risk of breast cancer and at low risk of medication-related adverse events.
    • Routine preventive medication is not recommended for women who are not at increased risk.
  • Note: This committee advises clinicians to screen for breast cancer in transgender and transfeminine men and cisgender females.
Skin cancer USPSTF: Skin Cancer Prevention: Behavioral Counseling (2018) USPSTF: Counsel patients to minimize ultraviolet radiation.
Falls USPSTF: Falls Prevention in Community-Dwelling Older Adults: Interventions (2018)
  • USPSTF: Exercise interventions are recommended for adults ≥65 years old who are at increased risk for falls.
  • Note: This committee advises clinicians to include osteoporosis screening.

Download Table 5: Primary Prevention for Adults With HIV Printable PDF

Prevention of Opportunistic Infections

Prevention of Opportunistic Infections
  • Clinicians should initiate prophylaxis for specific opportunistic infections (OIs) and discontinue prophylaxis as indicated in Table 6: Prophylaxis for Opportunistic Infections in Adults With HIV. (A*)
    • Before initiating dapsone, clinicians should test patients for glucose-6-phosphate dehydrogenase (G6PD) deficiency. (A*)
  • Clinicians may discontinue primary OI prophylaxis in patients who are taking effective ART and have evidence of immune recovery. (A*)

Abbreviations: ART, antiretroviral therapy; G6PD, glucose-6-phosphate dehydrogenase; OI, opportunistic infection.

The incidence of and mortality related to OIs have decreased since the early days of the HIV epidemic, but OIs remain a concern Masur 2015. Although the median initial CD4 cell count in individuals newly diagnosed with HIV has risen through the years NYSDOH 2019, a significant number of people have low CD4 cell counts at HIV diagnosis and are at risk for OIs Tominski, et al. 2017Ransome, et al. 2015. It is essential that clinicians who care for patients with HIV can identify common OIs and know when to provide and discontinue appropriate prophylaxis (see Table 6, below).

Abbreviations: ART, antiretroviral therapy; G6PD, glucose-6-phosphate dehydrogenase; IgG, immunoglobulin G; MAC, Mycobacterium avium complex; PJP, Pneumocystis jiroveci pneumonia; TE, Toxoplasma encephalitis; TMP/SMX, trimethoprim/sulfamethoxazole.


  1. Obtaining blood cultures or bone marrow cultures may be advisable to ascertain disease activity.
  2. Screen for G6PD deficiency before initiating dapsone.
  3. Lifelong prophylaxis to prevent recurrence is indicated in adults or adolescents with a childhood history of toxoplasmosis.
Table 6: Prophylaxis for Opportunistic Infections in Adults With HIV
Opportunistic Infection Indications for Initiation and Discontinuation of Primary Prophylaxis Preferred and Alternative Agent(s) Indications for Discontinuation of Secondary Prophylaxis
Cryptococcosis Primary prophylaxis is not routinely recommended. N/A
  • CD4 count >100 to 200 cells/mm3 for ≥6 months
  • Completed initial therapy, maintenance therapy for 1 year, and is asymptomatic for cryptococcosis
Cytomegalovirus Primary prophylaxis is not routinely recommended. N/A
  • CD4 count >100 to 150 cells/mm3 for ≥6 months
  • No evidence of active disease
  • Engaged in routine ophthalmologic examination
Mycobacterium avium complex
  • Initiation: Not recommended for individuals who are rapidly initiating ART or who are on ART and have an undetectable viral load
  • Discontinuation: Taking ART and CD4 count >100 cells/mm3 for ≥3 months
  • Preferred: Azithromycin; clarithromycin
  • Alternative: Rifabutin; azithromycin plus rifabutin
  • Taking ART and CD4 count >100 cells/mm3 for ≥6 months
  • At least 12 months of MAC treatment completed [a]
  • Asymptomatic for MAC
Pneumocystis jiroveci pneumonia
(formerly Pneumocystis carinii pneumonia)
  • Initiation: CD4 count <200 cells/mm3 (or <14%) or history of oropharyngeal candidiasis
  • Discontinuation: Taking ART and CD4 count >200 cells/mm3 for ≥3 months
  • Preferred: TMP/SMX single strength once daily
  • Alternatives:
    • TMP/SMX double strength every other day
    • Dapsone [b]
    • Dapsone [b] plus pyrimethamine plus leucovorin
    • Atovaquone
    • Aerosolized pentamidine
  • Taking ART and CD4 count >200 cells/mm3 for ≥3 months
  • Adequate viral suppression
  • Continue prophylaxis if PJP occurs with CD4 count >200 cells/mm3 (or <14%)
  • Consider stopping prophylaxis if viral load is suppressed for ≥3 months and CD4 count >100 cells/mm3
Toxoplasma gondii encephalitis [a,c]
  • Initiation: CD4 count <100 cells/mmand positive serology for Toxoplasma gondii (IgG+)
  • Discontinuation: Taking ART and CD4 count >100 cells/mmfor ≥3 months
  • Preferred: TMP/SMX single strength once daily
  • Alternatives:
    • Dapsone [b] plus pyrimethamine plus leucovorin
    • Atovaquone with or without pyrimethamine plus leucovorin
  • Taking ART and CD4 count >200 cells/mm3 for ≥6 months
  • Initial therapy completed
  • Asymptomatic for TE

Download Table 6: Prophylaxis for Opportunistic Infections in Adults With HIV Printable PDF

Oral Health Complications

Dental Standards of Care Committee, May 2016

Oral health care is a critical component of comprehensive HIV medical management. Development of oral pathology is frequently associated with an underlying progression of HIV-disease status. A thorough soft-tissue examination may reveal pathology associated with dysphagia or odynophagia. Dental problems can result in or exacerbate nutritional problems. In addition, psychosocial and quality-of-life issues frequently are associated with the condition of the oral cavity and the dentition.

Medications and oral health: Many of the medications taken by patients with HIV have side effects that may manifest in the oral cavity. Potential side effects include the following:

  • Candidal growth: Antibiotics may cause or exacerbate
  • Xerostomia: Antihistamines, antidepressants, antipsychotics, antihypertensives, and anticholinergic agents
  • Increased risk of dental caries: Clotrimazole troches and nystatin suspension pastilles (contain sugar)
  • Gingival hyperplasia: Phenytoin
  • Oral ulcers: Zalcitabine (DDC)

Good practice reminders:

  • Dental care referral: Include as part of every primary health care initial visit; semiannual oral healthcare visits are essential to dental prophylaxis and other appropriate preventive care. In the later stages of HIV disease, greater numbers of oral lesions and aggressive periodontal breakdown are more likely and may necessitate oral healthcare visits more frequently than twice per year.
  • Oral examination: Include a visual examination and palpation of the patient’s lips, labial and buccal mucosa, all surfaces of the tongue and palate, and the floor of the mouth in the overall physical examination performed during a primary care visit. The gingiva should be examined for signs of erythema, ulceration, or recession. Refer patients found to have oral mucosal, gingival, or dental lesions for a visit to an oral healthcare provider as soon as possible for appropriate diagnostic evaluation and treatment.
  • Oral care education: Include preventive oral health care in primary care patient education to stress the importance of regular dental visits, brushing, flossing, and the use of fluorides and antimicrobial rinses.

All Recommendations

History, Assessment, and Evaluation
Routine Screening and Primary Prevention
  • For adults with HIV who are seen for primary care, clinicians should provide:
  • Clinicians and patients should engage in shared decision-making regarding routine health screening tests, weighing the risks and benefits of screening based on such factors as life expectancy, cost, potential harms, and HIV-compounded risk. (A3)
Prevention of Opportunistic Infections
  • Clinicians should initiate prophylaxis for specific opportunistic infections (OIs) and discontinue prophylaxis as indicated in Table 6: Prophylaxis for Opportunistic Infections in Adults With HIV. (A*)
    • Before initiating dapsone, clinicians should test patients for glucose-6-phosphate dehydrogenase (G6PD) deficiency. (A*)
  • Clinicians may discontinue primary OI prophylaxis in patients who are taking effective ART and have evidence of immune recovery. (A*)

Abbreviations: ART, antiretroviral therapy; G6PD, glucose-6-phosphate dehydrogenase; OI, opportunistic infection.

Shared Decision-Making

Download Printable PDF of Shared Decision-Making Statement

Date of current publication: August 8, 2023
Lead authors:
Jessica Rodrigues, MS; Jessica M. Atrio, MD, MSc; and Johanna L. Gribble, MA
Writing group: Steven M. Fine, MD, PhD; Rona M. Vail, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: August 8, 2023


Throughout its guidelines, the New York State Department of Health (NYSDOH) AIDS Institute (AI) Clinical Guidelines Program recommends “shared decision-making,” an individualized process central to patient-centered care. With shared decision-making, clinicians and patients engage in meaningful dialogue to arrive at an informed, collaborative decision about a patient’s health, care, and treatment planning. The approach to shared decision-making described here applies to recommendations included in all program guidelines. The included elements are drawn from a comprehensive review of multiple sources and similar  attempts to define shared decision-making, including the Institute of Medicine’s original description [Institute of Medicine 2001]. For more information, a variety of informative resources and suggested readings are included at the end of the discussion.


The benefits to patients that have been associated with a shared decision-making approach include:

  • Decreased anxiety [Niburski, et al. 2020; Stalnikowicz and Brezis 2020]
  • Increased trust in clinicians [Acree, et al. 2020; Groot, et al. 2020; Stalnikowicz and Brezis 2020]
  • Improved engagement in preventive care [McNulty, et al. 2022; Scalia, et al. 2022; Bertakis and Azari 2011]
  • Improved treatment adherence, clinical outcomes, and satisfaction with care [Crawford, et al. 2021; Bertakis and Azari 2011; Robinson, et al. 2008]
  • Increased knowledge, confidence, empowerment, and self-efficacy [Chen, et al. 2021; Coronado-Vázquez, et al. 2020; Niburski, et al. 2020]


Collaborative care: Shared decision-making is an approach to healthcare delivery that respects a patient’s autonomy in responding to a clinician’s recommendations and facilitates dynamic, personalized, and collaborative care. Through this process, a clinician engages a patient in an open and respectful dialogue to elicit the patient’s knowledge, experience, healthcare goals, daily routine, lifestyle, support system, cultural and personal identity, and attitudes toward behavior, treatment, and risk. With this information and the clinician’s clinical expertise, the patient and clinician can collaborate to identify, evaluate, and choose from among available healthcare options [Coulter and Collins 2011]. This process emphasizes the importance of a patient’s values, preferences, needs, social context, and lived experience in evaluating the known benefits, risks, and limitations of a clinician’s recommendations for screening, prevention, treatment, and follow-up. As a result, shared decision-making also respects a patient’s autonomy, agency, and capacity in defining and managing their healthcare goals. Building a clinician-patient relationship rooted in shared decision-making can help clinicians engage in productive discussions with patients whose decisions may not align with optimal health outcomes. Fostering open and honest dialogue to understand a patient’s motivations while suspending judgment to reduce harm and explore alternatives is particularly vital when a patient chooses to engage in practices that may exacerbate or complicate health conditions [Halperin, et al. 2007].

Options: Implicit in the shared decision-making process is the recognition that the “right” healthcare decisions are those made by informed patients and clinicians working toward patient-centered and defined healthcare goals. When multiple options are available, shared decision-making encourages thoughtful discussion of the potential benefits and potential harms of all options, which may include doing nothing or waiting. This approach also acknowledges that efficacy may not be the most important factor in a patient’s preferences and choices [Sewell, et al. 2021].

Clinician awareness: The collaborative process of shared decision-making is enhanced by a clinician’s ability to demonstrate empathic interest in the patient, avoid stigmatizing language, employ cultural humility, recognize systemic barriers to equitable outcomes, and practice strategies of self-awareness and mitigation against implicit personal biases [Parish, et al. 2019].

Caveats: It is important for clinicians to recognize and be sensitive to the inherent power and influence they maintain throughout their interactions with patients. A clinician’s identity and community affiliations may influence their ability to navigate the shared decision-making process and develop a therapeutic alliance with the patient and may affect the treatment plan [KFF 2023; Greenwood, et al. 2020]. Furthermore, institutional policy and regional legislation, such as requirements for parental consent for gender-affirming care for transgender people or insurance coverage for sexual health care, may infringe upon a patient’s ability to access preventive- or treatment-related care [Sewell, et al. 2021].

Figure 1: Elements of Shared Decision-Making

Figure 1: Elements of Shared Decision-Making

Download figure: Elements of Shared Decision-Making

Health equity: Adapting a shared decision-making approach that supports diverse populations is necessary to achieve more equitable and inclusive health outcomes [Castaneda-Guarderas, et al. 2016]. For instance, clinicians may need to incorporate cultural- and community-specific considerations into discussions with women, gender-diverse individuals, and young people concerning their sexual behaviors, fertility intentions, and pregnancy or lactation status. Shared decision-making offers an opportunity to build trust among marginalized and disenfranchised communities by validating their symptoms, values, and lived experience. Furthermore, it can allow for improved consistency in patient screening and assessment of prevention options and treatment plans, which can reduce the influence of social constructs and implicit bias [Castaneda-Guarderas, et al. 2016].

Clinician bias has been associated with health disparities and can have profoundly negative effects [FitzGerald and Hurst 2017; Hall, et al. 2015]. It is often challenging for clinicians to recognize and set aside personal biases and to address biases with peers and colleagues. Consciously or unconsciously, negative or stigmatizing assumptions are often made about patient characteristics, such as race, ethnicity, gender, sexual orientation, mental health, and substance use [Avery, et al. 2019; van Boekel, et al. 2013; Livingston, et al. 2012]. With its emphasis on eliciting patient information, a shared decision-making approach encourages clinicians to inquire about patients’ lived experiences rather than making assumptions and to recognize the influence of that experience in healthcare decision-making.

Stigma: Stigma may prevent individuals from seeking or receiving treatment and harm reduction services [Tsai, et al. 2019]. Among people with HIV, stigma and medical mistrust remain significant barriers to healthcare utilization, HIV diagnosis, and medication adherence and can affect disease outcomes [Turan, et al. 2017; Chambers, et al. 2015], and stigma among clinicians against people who use substances has been well-documented [Stone, et al. 2021; Tsai, et al. 2019; van Boekel, et al. 2013]. Sexual and reproductive health, including strategies to prevent HIV transmission, acquisition, and progression, may be subject to stigma, bias, social influence, and violence.

  • As prevention and treatment modalities in HIV care expand (i.e., vaccines, barriers, injectables, implants, on-demand therapies), it is important for clinicians to ask patients about their goals for prevention and treatment rather than assume that efficacy is the primary factor in patient preference [Sewell, et al. 2021].
  • The shared decision-making approach to clinical care enhances patient knowledge and uptake of new technologies and behavioral practices that align with the patient’s unique preferences and identity [Sewell, et al. 2021], ensures that the selection of a care plan is mutually agreed upon, and considers the patient’s ability to effectively use and adhere to the selected course of prevention or treatment.

Resources and Suggested Reading

In addition to the references cited below, the following resources and suggested reading may be useful to clinicians.


Acree ME, McNulty M, Blocker O, et al. Shared decision-making around anal cancer screening among black bisexual and gay men in the USA. Cult Health Sex 2020;22(2):201-16. [PMID: 30931831]

Avery JD, Taylor KE, Kast KA, et al. Attitudes toward individuals with mental illness and substance use disorders among resident physicians. Prim Care Companion CNS Disord 2019;21(1):18m02382. [PMID: 30620451]

Bertakis KD, Azari R. Patient-centered care is associated with decreased health care utilization. J Am Board Fam Med 2011;24(3):229-39. [PMID: 21551394]

Castaneda-Guarderas A, Glassberg J, Grudzen CR, et al. Shared decision making with vulnerable populations in the emergency department. Acad Emerg Med 2016;23(12):1410-16. [PMID: 27860022]

Chambers LA, Rueda S, Baker DN, et al. Stigma, HIV and health: a qualitative synthesis. BMC Public Health 2015;15:848. [PMID: 26334626]

Chen CH, Kang YN, Chiu PY, et al. Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: a randomized controlled trial. Patient Educ Couns 2021;104(10):2498-2504. [PMID: 33741234]

Coronado-Vázquez V, Canet-Fajas C, Delgado-Marroquín MT, et al. Interventions to facilitate shared decision-making using decision aids with patients in primary health care: a systematic review. Medicine (Baltimore) 2020;99(32):e21389. [PMID: 32769870]

Coulter A, Collins A. Making shared decision-making a reality: no decision about me, without me. 2011.

Crawford J, Petrie K, Harvey SB. Shared decision-making and the implementation of treatment recommendations for depression. Patient Educ Couns 2021;104(8):2119-21. [PMID: 33563500]

FitzGerald C, Hurst S. Implicit bias in healthcare professionals: a systematic review. BMC Med Ethics 2017;18(1):19. [PMID: 28249596]

Greenwood BN, Hardeman RR, Huang L, et al. Physician-patient racial concordance and disparities in birthing mortality for newborns. Proc Natl Acad Sci U S A 2020;117(35):21194-21200. [PMID: 32817561]

Groot G, Waldron T, Barreno L, et al. Trust and world view in shared decision making with indigenous patients: a realist synthesis. J Eval Clin Pract 2020;26(2):503-14. [PMID: 31750600]

Hall WJ, Chapman MV, Lee KM, et al. Implicit racial/ethnic bias among health care professionals and its influence on health care outcomes: a systematic review. Am J Public Health 2015;105(12):e60-76. [PMID: 26469668]

Halperin B, Melnychuk R, Downie J, et al. When is it permissible to dismiss a family who refuses vaccines? Legal, ethical and public health perspectives. Paediatr Child Health 2007;12(10):843-45. [PMID: 19043497]

Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. 2001.

KFF. Key data on health and health care by race and ethnicity. 2023 Mar 15. [accessed 2023 May 19]

Livingston JD, Milne T, Fang ML, et al. The effectiveness of interventions for reducing stigma related to substance use disorders: a systematic review. Addiction 2012;107(1):39-50. [PMID: 21815959]

McNulty MC, Acree ME, Kerman J, et al. Shared decision making for HIV pre-exposure prophylaxis (PrEP) with black transgender women. Cult Health Sex 2022;24(8):1033-46. [PMID: 33983866]

Niburski K, Guadagno E, Abbasgholizadeh-Rahimi S, et al. Shared decision making in surgery: a meta-analysis of existing literature. Patient 2020;13(6):667-81. [PMID: 32880820]

Parish SJ, Hahn SR, Goldstein SW, et al. The International Society for the Study of Women’s Sexual Health process of care for the identification of sexual concerns and problems in women. Mayo Clin Proc 2019;94(5):842-56. [PMID: 30954288]

Robinson JH, Callister LC, Berry JA, et al. Patient-centered care and adherence: definitions and applications to improve outcomes. J Am Acad Nurse Pract 2008;20(12):600-607. [PMID: 19120591]

Scalia P, Durand MA, Elwyn G. Shared decision-making interventions: an overview and a meta-analysis of their impact on vaccine uptake. J Intern Med 2022;291(4):408-25. [PMID: 34700363]

Sewell WC, Solleveld P, Seidman D, et al. Patient-led decision-making for HIV preexposure prophylaxis. Curr HIV/AIDS Rep 2021;18(1):48-56. [PMID: 33417201]

Stalnikowicz R, Brezis M. Meaningful shared decision-making: complex process demanding cognitive and emotional skills. J Eval Clin Pract 2020;26(2):431-38. [PMID: 31989727]

Stone EM, Kennedy-Hendricks A, Barry CL, et al. The role of stigma in U.S. primary care physicians’ treatment of opioid use disorder. Drug Alcohol Depend 2021;221:108627. [PMID: 33621805]

Tsai AC, Kiang MV, Barnett ML, et al. Stigma as a fundamental hindrance to the United States opioid overdose crisis response. PLoS Med 2019;16(11):e1002969. [PMID: 31770387]

Turan B, Budhwani H, Fazeli PL, et al. How does stigma affect people living with HIV? The mediating roles of internalized and anticipated HIV stigma in the effects of perceived community stigma on health and psychosocial outcomes. AIDS Behav 2017;21(1):283-91. [PMID: 27272742]

van Boekel LC, Brouwers EP, van Weeghel J, et al. Stigma among health professionals towards patients with substance use disorders and its consequences for healthcare delivery: systematic review. Drug Alcohol Depend 2013;131(1-2):23-35. [PMID: 23490450]


Aberg J. A., Gallant J. E., Ghanem K. G., et al. Primary care guidelines for the management of persons infected with HIV: 2013 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis 2014;58(1):1-10. [PMID: 24343580]

Almeida A., Boattini M. Community-acquired pneumonia in HIV-positive patients: an update on etiologies, epidemiology and management. Curr Infect Dis Rep 2017;19(1):2. [PMID: 28160220]

Alpalhão M., Borges-Costa J., Filipe P. Psoriasis in HIV infection: an update. Int J STD AIDS 2019;30(6):596-604. [PMID: 30813860]

Althoff K. N., Gebo K. A., Moore R. D., et al. Contributions of traditional and HIV-related risk factors on non-AIDS-defining cancer, myocardial infarction, and end-stage liver and renal diseases in adults with HIV in the USA and Canada: a collaboration of cohort studies. Lancet HIV 2019;6(2):e93-104. [PMID: 30683625]

Althoff K. N., McGinnis K. A., Wyatt C. M., et al. Comparison of risk and age at diagnosis of myocardial infarction, end-stage renal disease, and non-AIDS-defining cancer in HIV-infected versus uninfected adults. Clin Infect Dis 2015;60(4):627-38. [PMID: 25362204]

Baker J. V., Peng G., Rapkin J., et al. Poor initial CD4+ recovery with antiretroviral therapy prolongs immune depletion and increases risk for AIDS and non-AIDS diseases. J Acquir Immune Defic Syndr 2008;48(5):541-46. [PMID: 18645520]

Basso M., Andreis S., Scaggiante R., et al. Cytomegalovirus, Epstein-Barr virus and human herpesvirus 8 salivary shedding in HIV positive men who have sex with men with controlled and uncontrolled plasma HIV viremia: a 24-month longitudinal study. BMC Infect Dis 2018;18(1):683. [PMID: 30567494]

Benhamou Y., Bochet M., Di Martino V., et al. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. The Multivirc Group. Hepatology 1999;30(4):1054-58. [PMID: 10498659]

Bertz R. J., Persson A., Chung E., et al. Pharmacokinetics and pharmacodynamics of atazanavir-containing antiretroviral regimens, with or without ritonavir, in patients who are HIV-positive and treatment-naïve. Pharmacotherapy 2013;33(3):284-94. [PMID: 23456732]

Bigna J. J., Kenne A. M., Asangbeh S. L., et al. Prevalence of chronic obstructive pulmonary disease in the global population with HIV: a systematic review and meta-analysis. Lancet Glob Health 2018;6(2):e193-202. [PMID: 29254748]

Borges A. H., Dubrow R., Silverberg M. J. Factors contributing to risk for cancer among HIV-infected individuals, and evidence that earlier combination antiretroviral therapy will alter this risk. Curr Opin HIV AIDS 2014;9(1):34-40. [PMID: 24225382]

Bosh K. A., Coyle J. R., Hansen V., et al. HIV and viral hepatitis coinfection analysis using surveillance data from 15 US states and two cities. Epidemiol Infect 2018;146(7):920-30. [PMID: 29636119]

Bourgi(a) K., Rebeiro P. F., Turner M., et al. Greater weight gain in treatment-naive persons starting dolutegravir-based antiretroviral therapy. Clin Infect Dis 2020;70(7):1267-74. [PMID: 31100116]

Bourgi(b) K., Jenkins C. A., Rebeiro P. F., et al. Weight gain among treatment-naïve persons with HIV starting integrase inhibitors compared to non-nucleoside reverse transcriptase inhibitors or protease inhibitors in a large observational cohort in the United States and Canada. J Int AIDS Soc 2020;23(4):e25484. [PMID: 32294337]

Bower M., Weir J., Francis N., et al. The effect of HAART in 254 consecutive patients with AIDS-related Kaposi's sarcoma. AIDS 2009;23(13):1701-6. [PMID: 19550283]

Brennan-Ing M., Seidel L., Rodgers L., et al. The impact of comprehensive case management on HIV client outcomes. PLoS One 2016;11(2):e0148865. [PMID: 26849561]

Brickman C., Palefsky J. M. Human papillomavirus in the HIV-infected host: epidemiology and pathogenesis in the antiretroviral era. Curr HIV/AIDS Rep 2015;12(1):6-15. [PMID: 25644977]

Brown J., Roy A., Harris R., et al. Respiratory symptoms in people living with HIV and the effect of antiretroviral therapy: a systematic review and meta-analysis. Thorax 2017;72(4):355-66. [PMID: 27965402]

Bruchfeld J., Correia-Neves M., Källenius G. Tuberculosis and HIV coinfection. Cold Spring Harb Perspect Med 2015;5(7):a017871. [PMID: 25722472]

Cabral H. J., Davis-Plourde K., Sarango M., et al. Peer support and the HIV continuum of care: results from a multi-site randomized clinical trial in three urban clinics in the United States. AIDS Behav 2018;22(8):2627-39. [PMID: 29306990]

Castilho J. L., Bian A., Jenkins C. A., et al. CD4/CD8 ratio and cancer risk among adults with HIV. J Natl Cancer Inst 2022;114(6):854-62. [PMID: 35292820]

CDC. HIV surveillance report: diagnoses of HIV infection in the United States and dependent areas, 2018. 2020 May 7. [accessed 2022 Oct 27]

Chambers L. A., Rueda S., Baker D. N., et al. Stigma, HIV and health: a qualitative synthesis. BMC Public Health 2015;15:848. [PMID: 26334626]

Cheng Q. J., Engelage E. M., Grogan T. R., et al. Who provides primary care? An assessment of HIV patient and provider practices and preferences. J AIDS Clin Res 2014;5(11):366. [PMID: 25914854]

Chiarella S. E., Grammer L. C. Immune deficiency in chronic rhinosinusitis: screening and treatment. Expert Rev Clin Immunol 2017;13(2):117-23. [PMID: 27500811]

Clifford G. M., Tully S., Franceschi S. Carcinogenicity of human papillomavirus (HPV) types in HIV-positive women: a meta-analysis from HPV infection to cervical cancer. Clin Infect Dis 2017;64(9):1228-35. [PMID: 28199532]

Collazos J., Valle-Garay E., Carton J. A., et al. Factors associated with long-term CD4 cell recovery in HIV-infected patients on successful antiretroviral therapy. HIV Med 2016;17(7):532-41. [PMID: 26754349]

Compston J. HIV infection and bone disease. J Intern Med 2016;280(4):350-58. [PMID: 27272530]

Crothers K., Butt A. A., Gibert C. L., et al. Increased COPD among HIV-positive compared to HIV-negative veterans. Chest 2006;130(5):1326-33. [PMID: 17099007]

Crum-Cianflone N., Ganesan A., Teneza-Mora N., et al. Prevalence and factors associated with renal dysfunction among HIV-infected patients. AIDS Patient Care STDS 2010;24(6):353-60. [PMID: 20515419]

Cunningham W. E., Weiss R. E., Nakazono T., et al. Effectiveness of a peer navigation intervention to sustain viral suppression among HIV-positive men and transgender women released from jail: The LINK LA randomized clinical trial. JAMA Intern Med 2018;178(4):542-53. [PMID: 29532059]

Cysique L. A., Brew B. J. Comorbid depression and apathy in HIV-associated neurocognitive disorders in the era of chronic HIV infection. Handb Clin Neurol 2019;165:71-82. [PMID: 31727231]

Deeken J. F., Tjen-A-Looi A., Rudek M. A., et al. The rising challenge of non-AIDS-defining cancers in HIV-infected patients. Clin Infect Dis 2012;55(9):1228-35. [PMID: 22776851]

Deeks S. G. HIV infection, inflammation, immunosenescence, and aging. Annu Rev Med 2011;62:141-55. [PMID: 21090961]

Deeks S. G., Overbaugh J., Phillips A., et al. HIV infection. Nat Rev Dis Primers 2015;1:15035. [PMID: 27188527]

Drozd D. R., Kitahata M. M., Althoff K. N., et al. Increased risk of myocardial infarction in HIV-infected individuals in North America compared with the general population. J Acquir Immune Defic Syndr 2017;75(5):568-76. [PMID: 28520615]

El-Sadr W. M., Lundgren J. D., Neaton J. D., et al. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med 2006;355(22):2283-96. [PMID: 17135583]

Ellis R. J., Badiee J., Vaida F., et al. CD4 nadir is a predictor of HIV neurocognitive impairment in the era of combination antiretroviral therapy. AIDS 2011;25(14):1747-51. [PMID: 21750419]

Emery S., Neuhaus J. A., Phillips A. N., et al. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study. J Infect Dis 2008;197(8):1133-44. [PMID: 18476292]

Epstein J. B. Oral malignancies associated with HIV. J Can Dent Assoc 2007;73(10):953-56. [PMID: 18275699]

Erdmann N. B., Prentice H. A., Bansal A., et al. Herpes zoster in persons living with HIV-1 infection: viremia and immunological defects are strong risk factors in the era of combination antiretroviral therapy. Front Public Health 2018;6:70. [PMID: 29594092]

Flórez K. R., Payán D. D., Derose K. P., et al. Process evaluation of a peer-driven, HIV stigma reduction and HIV testing intervention in Latino and African American churches. Health Equity 2017;1(1):109-17. [PMID: 30283840]

Fujimoto K., Flash C. A., Kuhns L. M., et al. Social networks as drivers of syphilis and HIV infection among young men who have sex with men. Sex Transm Infect 2018;94(5):365-71. [PMID: 29440465]

Gazzaruso C., Bruno R., Garzaniti A., et al. Hypertension among HIV patients: prevalence and relationships to insulin resistance and metabolic syndrome. J Hypertens 2003;21(7):1377-82. [PMID: 12817187]

Geter A., Herron A. R., Sutton M. Y. HIV-related stigma by healthcare providers in the United States: a systematic review. AIDS Patient Care STDS 2018;32(10):418-24. [PMID: 30277814]

Gilbert L., Wang X., Deiss R., et al. Herpes zoster rates continue to decline in people living with human immunodeficiency virus but remain higher than rates reported in the general US population. Clin Infect Dis 2019;69(1):155-58. [PMID: 30561578]

Giordano T. P., Cully J., Amico K. R., et al. A randomized trial to test a peer mentor intervention to improve outcomes in persons hospitalized with HIV infection. Clin Infect Dis 2016;63(5):678-86. [PMID: 27217266]

Graham C. S., Baden L. R., Yu E., et al. Influence of human immunodeficiency virus infection on the course of hepatitis C virus infection: a meta-analysis. Clin Infect Dis 2001;33(4):562-69. [PMID: 11462196]

Green M. S., Prystowsky J. H., Cohen S. R., et al. Infectious complications of erythrodermic psoriasis. J Am Acad Dermatol 1996;34(5 Pt 2):911-14. [PMID: 8621827]

Greene M., Covinsky K. E., Valcour V., et al. Geriatric syndromes in older HIV-infected adults. J Acquir Immune Defic Syndr 2015;69(2):161-67. [PMID: 26009828]

Grigsby I. F., Pham L., Mansky L. M., et al. Tenofovir-associated bone density loss. Ther Clin Risk Manag 2010;6:41-47. [PMID: 20169035]

Gueler A., Moser A., Calmy A., et al. Life expectancy in HIV-positive persons in Switzerland: matched comparison with general population. AIDS 2017;31(3):427-36. [PMID: 27831953]

Guiguet M., Boue F., Cadranel J., et al. Effect of immunodeficiency, HIV viral load, and antiretroviral therapy on the risk of individual malignancies (FHDH-ANRS CO4): a prospective cohort study. Lancet Oncol 2009;10(12):1152-59. [PMID: 19818686]

Helleberg M., May M. T., Ingle S. M., et al. Smoking and life expectancy among HIV-infected individuals on antiretroviral therapy in Europe and North America. AIDS 2015;29(2):221-29. [PMID: 25426809]

Ioannidis J. P., Abrams E. J., Ammann A., et al. Perinatal transmission of human immunodeficiency virus type 1 by pregnant women with RNA virus loads <1000 copies/ml. J Infect Dis 2001;183(4):539-45. [PMID: 11170978]

Islam F. M., Wu J., Jansson J., et al. Relative risk of renal disease among people living with HIV: a systematic review and meta-analysis. BMC Public Health 2012;12:234. [PMID: 22439731]

Jabs D. A. Ocular manifestations of HIV infection. Trans Am Ophthalmol Soc 1995;93:623-83. [PMID: 8719695]

Kaspar M. B., Sterling R. K. Mechanisms of liver disease in patients infected with HIV. BMJ Open Gastroenterol 2017;4(1):e000166. [PMID: 29119002]

Kerr C. A., Neeman N., Davis R. B., et al. HIV quality of care assessment at an academic hospital: outcomes and lessons learned. Am J Med Qual 2012;27(4):321-28. [PMID: 22326983]

Komatsu A., Ikeda A., Kikuchi A., et al. Osteoporosis-related fractures in HIV-infected patients receiving long-term tenofovir disoproxil fumarate: an observational cohort study. Drug Saf 2018;41(9):843-48. [PMID: 29623648]

Kral A. H., Lambdin B. H., Comfort M., et al. A strengths-based case management intervention to reduce HIV viral load among people who use drugs. AIDS Behav 2018;22(1):146-53. [PMID: 28916898]

Landon B. E., Wilson I. B., McInnes K., et al. Physician specialization and the quality of care for human immunodeficiency virus infection. Arch Intern Med 2005;165(10):1133-39. [PMID: 15911726]

Lang S., Mary-Krause M., Simon A., et al. HIV replication and immune status are independent predictors of the risk of myocardial infarction in HIV-infected individuals. Clin Infect Dis 2012;55(4):600-607. [PMID: 22610928]

Limper A. H., Adenis A., Le T., et al. Fungal infections in HIV/AIDS. Lancet Infect Dis 2017;17(11):e334-43. [PMID: 28774701]

Lundgren J. D., Babiker A. G., Gordin F., et al. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med 2015;373(9):795-807. [PMID: 26192873]

Machalek D. A., Poynten M., Jin F., et al. Anal human papillomavirus infection and associated neoplastic lesions in men who have sex with men: a systematic review and meta-analysis. Lancet Oncol 2012;13(5):487-500. [PMID: 22445259]

Maggi P., Santoro C. R., Nofri M., et al. Clusterization of co-morbidities and multi-morbidities among persons living with HIV: a cross-sectional study. BMC Infect Dis 2019;19(1):555. [PMID: 31238916]

Malek J., Rogers R., Kufera J., et al. Venous thromboembolic disease in the HIV-infected patient. Am J Emerg Med 2011;29(3):278-82. [PMID: 20825798]

Mankal P. K., Kotler D. P. From wasting to obesity, changes in nutritional concerns in HIV/AIDS. Endocrinol Metab Clin North Am 2014;43(3):647-63. [PMID: 25169559]

Marcus J. L., Leyden W. A., Alexeeff S. E., et al. Comparison of overall and comorbidity-free life expectancy between insured adults with and without HIV infection, 2000-2016. JAMA Netw Open 2020;3(6):e207954. [PMID: 32539152]

Marin B., Thiebaut R., Bucher H. C., et al. Non-AIDS-defining deaths and immunodeficiency in the era of combination antiretroviral therapy. AIDS 2009;23(13):1743-53. [PMID: 19571723]

Masur H. HIV-related opportunistic infections are still relevant in 2015. Top Antivir Med 2015;23(3):116-19. [PMID: 26518395]

May M. T., Vehreschild J. J., Trickey A., et al. Mortality according to CD4 count at start of combination antiretroviral therapy among HIV-infected patients followed for up to 15 years after start of treatment: collaborative cohort study. Clin Infect Dis 2016;62(12):1571-77. [PMID: 27025828]

McMahon C. N., Petoumenos K., Hesse K., et al. High rates of incident diabetes and prediabetes are evident in men with treated HIV followed for 11 years. AIDS 2018;32(4):451-59. [PMID: 29381559]

Metsch L. R., Feaster D. J., Gooden L., et al. Effect of patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use: a randomized clinical trial. JAMA 2016;316(2):156-70. [PMID: 27404184]

Miller W. C., Hoffman I. F., Hanscom B. S., et al. A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study. Lancet 2018;392(10149):747-59. [PMID: 30191830]

Monroe A. K., Glesby M. J., Brown T. T. Diagnosing and managing diabetes in HIV-infected patients: current concepts. Clin Infect Dis 2015;60(3):453-62. [PMID: 25313249]

Morales Rodriguez K., Khalili J., Trevillyan J., et al. What is the best model for HIV primary care? Assessing the influence of provider type on outcomes of chronic comorbidities in HIV infection. J Infect Dis 2018;218(2):337-39. [PMID: 29481635]

Nakamoto B. K., Dorotheo E. U., Biousse V., et al. Progressive outer retinal necrosis presenting with isolated optic neuropathy. Neurology 2004;63(12):2423-25. [PMID: 15623719]

Nanni M. G., Caruso R., Mitchell A. J., et al. Depression in HIV infected patients: a review. Curr Psychiatry Rep 2015;17(1):530. [PMID: 25413636]

Nansseu J. R., Bigna J. J., Kaze A. D., et al. Incidence and risk factors for prediabetes and diabetes mellitus among HIV-infected adults on antiretroviral therapy: a systematic review and meta-analysis. Epidemiology 2018;29(3):431-41. [PMID: 29394189]

Noubissi E. C., Katte J. C., Sobngwi E. Diabetes and HIV. Curr Diab Rep 2018;18(11):125. [PMID: 30294763]

NYSDOH. New York State HIV/AIDS annual surveillance report: for persons diagnosed through December 2018. 2019 Dec. [accessed 2022 Oct 27]

Pacek L. R., Cioe P. A. Tobacco use, use disorders, and smoking cessation interventions in persons living with HIV. Curr HIV/AIDS Rep 2015;12(4):413-20. [PMID: 26391516]

Park L. S., Hernandez-Ramirez R. U., Silverberg M. J., et al. Prevalence of non-HIV cancer risk factors in persons living with HIV/AIDS: a meta-analysis. AIDS 2016;30(2):273-91. [PMID: 26691548]

Penot P., Colombier M. A., Maylin S., et al. Hepatitis A infections in men who have sex with men using HIV PrEP in Paris. BMJ Case Rep 2018;2018:bcr2017222248. [PMID: 29326373]

Pinato D. J., Allara E., Chen T. Y., et al. Influence of HIV infection on the natural history of hepatocellular carcinoma: results from a global multicohort study. J Clin Oncol 2019;37(4):296-304. [PMID: 30562130]

Raja S., Hasnain M., Hoersch M., et al. Trauma informed care in medicine: current knowledge and future research directions. Fam Community Health 2015;38(3):216-26. [PMID: 26017000]

Ransome Y., Terzian A., Addison D., et al. Expanded HIV testing coverage is associated with decreases in late HIV diagnoses. AIDS 2015;29(11):1369-78. [PMID: 26091296]

Rao D., Kemp C. G., Huh D., et al. Stigma reduction among African American women with HIV: UNITY health study. J Acquir Immune Defic Syndr 2018;78(3):269-75. [PMID: 29528941]

Rhodes C. M., Chang Y., Regan S., et al. Non-communicable disease preventive screening by HIV care model. PLoS One 2017;12(1):e0169246. [PMID: 28060868]

Risso K., Guillouet-de-Salvador F., Valerio L., et al. COPD in HIV-infected patients: CD4 cell count highly correlated. PLoS One 2017;12(1):e0169359. [PMID: 28056048]

Samji H., Cescon A., Hogg R. S., et al. Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One 2013;8(12):e81355. [PMID: 24367482]

Sax P. E., Erlandson K. M., Lake J. E., et al. Weight gain following initiation of antiretroviral therapy: risk factors in randomized comparative clinical trials. Clin Infect Dis 2020;71(6):1379-89. [PMID: 31606734]

Schnall R., Jia H., Olender S., et al. In people living with HIV (PLWH), menopause (natural or surgical) contributes to the greater symptom burden in women: results from an online US survey. Menopause 2018;25(7):744-52. [PMID: 29509596]

Serrano-Villar S., Sainz T., Lee S. A., et al. HIV-infected individuals with low CD4/CD8 ratio despite effective antiretroviral therapy exhibit altered T cell subsets, heightened CD8+ T cell activation, and increased risk of non-AIDS morbidity and mortality. PLoS Pathog 2014;10(5):e1004078. [PMID: 24831517]

Shah A. S. V., Stelzle D., Lee K. K., et al. Global burden of atherosclerotic cardiovascular disease in people living with HIV: systematic review and meta-analysis. Circulation 2018;138(11):1100-1112. [PMID: 29967196]

Sherr L., Nagra N., Kulubya G., et al. HIV infection associated post-traumatic stress disorder and post-traumatic growth--a systematic review. Psychol Health Med 2011;16(5):612-29. [PMID: 21793667]

Shiels M. S., Pfeiffer R. M., Gail M. H., et al. Cancer burden in the HIV-infected population in the United States. J Natl Cancer Inst 2011;103(9):753-62. [PMID: 21483021]

Siika A., McCabe L., Bwakura-Dangarembizi M., et al. Late presentation with HIV in Africa: phenotypes, risk, and risk stratification in the REALITY trial. Clin Infect Dis 2018;66(Suppl 2):s140-46. [PMID: 29514235]

Singh K. P., Crane M., Audsley J., et al. HIV-hepatitis B virus coinfection: epidemiology, pathogenesis, and treatment. AIDS 2017;31(15):2035-52. [PMID: 28692539]

Small C. B., Rosenstreich D. L. Sinusitis in HIV infection. Immunol Allergy Clin North Am 1997;17(2):267-89.

Sorensen P. Manifestations of HIV in the head and neck. Curr Infect Dis Rep 2011;13(2):115-22. [PMID: 21365374]

Soti S., Corey K. E., Lake J. E., et al. NAFLD and HIV: do sex, race, and ethnicity explain HIV-related risk?. Curr HIV/AIDS Rep 2018;15(3):212-22. [PMID: 29671204]

Stirrup O. T., Copas A. J., Phillips A. N., et al. Predictors of CD4 cell recovery following initiation of antiretroviral therapy among HIV-1 positive patients with well-estimated dates of seroconversion. HIV Med 2018;19(3):184-94. [PMID: 29230953]

Sugar E. A., Jabs D. A., Ahuja A., et al. Incidence of cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am J Ophthalmol 2012;153(6):1016-24. [PMID: 22310076]

Swanepoel C. R., Atta M. G., D'Agati V. D., et al. Kidney disease in the setting of HIV infection: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int 2018;93(3):545-59. [PMID: 29398134]

Tang C., Goldsamt L., Meng J., et al. Global estimate of the prevalence of post-traumatic stress disorder among adults living with HIV: a systematic review and meta-analysis. BMJ Open 2020;10(4):e032435. [PMID: 32345695]

Thio C. L., Seaberg E. C., Skolasky R., et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet 2002;360(9349):1921-26. [PMID: 12493258]

Thompson M. A., Horberg M. A., Agwu A. L., et al. Primary care guidance for persons with human immunodeficiency virus: 2020 update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis 2021;73(11):e3572-3605. [PMID: 33225349]

Tominski D., Katchanov J., Driesch D., et al. The late-presenting HIV-infected patient 30 years after the introduction of HIV testing: spectrum of opportunistic diseases and missed opportunities for early diagnosis. HIV Med 2017;18(2):125-32. [PMID: 27478058]

Tozzi V., Balestra P., Bellagamba R., et al. Persistence of neuropsychologic deficits despite long-term highly active antiretroviral therapy in patients with HIV-related neurocognitive impairment: prevalence and risk factors. J Acquir Immune Defic Syndr 2007;45(2):174-82. [PMID: 17356465]

Trevillyan J. M., Chang J. J., Currier J. S. Prevalence of dental symptoms and access to dental care in an American HIV outpatient clinic. Oral Dis 2018;24(5):866-67. [PMID: 28779509]

Triant V. A. Cardiovascular disease and HIV infection. Curr HIV/AIDS Rep 2013;10(3):199-206. [PMID: 23793823]

Trickey A., May M. T., Vehreschild J., et al. Cause-specific mortality in HIV-positive patients who survived ten years after starting antiretroviral therapy. PLoS One 2016;11(8):e0160460. [PMID: 27525413]

Turan B., Budhwani H., Fazeli P. L., et al. How does stigma affect people living with HIV? The mediating roles of internalized and anticipated HIV stigma in the effects of perceived community stigma on health and psychosocial outcomes. AIDS Behav 2017;21(1):283-91. [PMID: 27272742]

Weber R., Sabin C. A., Friis-Møller N., et al. Liver-related deaths in persons infected with the human immunodeficiency virus: the D:A:D study. Arch Intern Med 2006;166(15):1632-41. [PMID: 16908797]

Yarchoan R., Uldrick T. S. HIV-associated cancers and related diseases. N Engl J Med 2018;378(11):1029-41. [PMID: 29539283]

Yee D., Fu D., Hui C., et al. A rare case of 4 Ps: bilateral pneumothoraces and pneumomediastinum in pneumocystis pneumonia. R I Med J (2013) 2020;103(5):52-54. [PMID: 32481782]

Zwahlen M., Harris R., May M., et al. Mortality of HIV-infected patients starting potent antiretroviral therapy: comparison with the general population in nine industrialized countries. Int J Epidemiol 2009;38(6):1624-33. [PMID: 19820106]

Updates, Authorship, and Related Guidelines

Updates, Authorship, and Related Guidelines
Date of original publication February 09, 2021
Date of current publication December 15, 2022
Highlights of changes, additions, and updates in the December 15, 2022 edition
  • In Table 4: Routine Screening for Adults With HIV, the following changes were made: Screening recommendations for cervical and anal cancers were updated to align with recommendations in the NYSDOH AI guidelines Screening for Cervical Dysplasia and Cancer in Adults With HIV and Screening for Anal Dysplasia and Cancer in Patients With HIV.
  • Recommendations for routine vision screening were removed.
Intended users New York State clinicians who provide primary care for adults with HIV
Lead author(s)

Mary Dyer, MD; Christine Kerr, MD

Writing group

Steven M. Fine, MD, PhD; Rona Vail, MD; Joseph P. McGowan, MD, FACP, FIDSA; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD

Author and writing group conflict of interest disclosures

Joseph P. McGowan, MD, FACP, FIDSA: Institutional Pharma grant recipient/support, clinical trial; Gilead


Medical Care Criteria Committee

Developer and funder

New York State Department of Health AIDS Institute (NYSDOH AI)

Development process

See Guideline Development and Recommendation Ratings Scheme, below.

Related NYSDOH AI guidelines

Related NYSDOH AI Guidance

Guideline Development and Recommendation Ratings

Guideline Development: New York State Department of Health AIDS Institute Clinical Guidelines Program
Program manager Clinical Guidelines Program, Johns Hopkins University School of Medicine, Division of Infectious Diseases. See Program Leadership and Staff.
Mission To produce and disseminate evidence-based, state-of-the-art clinical practice guidelines that establish uniform standards of care for practitioners who provide prevention or treatment of HIV, viral hepatitis, other sexually transmitted infections, and substance use disorders for adults throughout New York State in the wide array of settings in which those services are delivered.
Expert committees The NYSDOH AI Medical Director invites and appoints committees of clinical and public health experts from throughout New York State to ensure that the guidelines are practical, immediately applicable, and meet the needs of care providers and stakeholders in all major regions of New York State, all relevant clinical practice settings, key New York State agencies, and community service organizations.
Committee structure
  • Leadership: AI-appointed chair, vice chair(s), chair emeritus, clinical specialist(s), JHU Guidelines Program Director, AI Medical Director, AI Clinical Consultant, AVAC community advisor
  • Contributing members
  • Guideline writing groups: Lead author, coauthors if applicable, and all committee leaders
Disclosure and management of conflicts of interest
  • Annual disclosure of financial relationships with commercial entities for the 12 months prior and upcoming is required of all individuals who work with the guidelines program, and includes disclosure for partners or spouses and primary professional affiliation.
  • The NYSDOH AI assesses all reported financial relationships to determine the potential for undue influence on guideline recommendations and, when indicated, denies participation in the program or formulates a plan to manage potential conflicts. Disclosures are listed for each committee member.
Evidence collection and review
  • Literature search and review strategy is defined by the guideline lead author based on the defined scope of a new guideline or update.
  • A comprehensive literature search and review is conducted for a new guideline or an extensive update using PubMed, other pertinent databases of peer-reviewed literature, and relevant conference abstracts to establish the evidence base for guideline recommendations.
  • A targeted search and review to identify recently published evidence is conducted for guidelines published within the previous 3 years.
  • Title, abstract, and article reviews are performed by the lead author. The JHU editorial team collates evidence and creates and maintains an evidence table for each guideline.
Recommendation development
  • The lead author drafts recommendations to address the defined scope of the guideline based on available published data.
  • Writing group members review the draft recommendations and evidence and deliberate to revise, refine, and reach consensus on all recommendations.
  • When published data are not available, support for a recommendation may be based on the committee’s expert opinion.
  • The writing group assigns a 2-part rating to each recommendation to indicate the strength of the recommendation and quality of the supporting evidence. The group reviews the evidence, deliberates, and may revise recommendations when required to reach consensus.
Review and approval process
  • Following writing group approval, draft guidelines are reviewed by all contributors, program liaisons, and a volunteer reviewer from the AI Community Advisory Committee.
  • Recommendations must be approved by two-thirds of the full committee. If necessary to achieve consensus, the full committee is invited to deliberate, review the evidence, and revise recommendations.
  • Final approval by the committee chair and the NYSDOH AI Medical Director is required for publication.
External reviews
  • External review of each guideline is invited at the developer’s discretion.
  • External reviewers recognized for their experience and expertise review guidelines for accuracy, balance, clarity, and practicality and provide feedback.
Update process
  • JHU editorial staff ensure that each guideline is reviewed and determined to be current upon the 3-year anniversary of publication; guidelines that provide clinical recommendations in rapidly changing areas of practice may be reviewed annually. Published literature is surveilled to identify new evidence that may prompt changes to existing recommendations or development of new recommendations.
  • If changes in the standard of care, newly published studies, new drug approval, new drug-related warning, or a public health emergency indicate the need for immediate change to published guidelines, committee leadership will make recommendations and immediate updates and will invite full committee review as indicated.
Recommendation Ratings Scheme
Strength Quality of Evidence
Rating Definition Rating Definition
A Strong 1 Based on published results of at least 1 randomized clinical trial with clinical outcomes or validated laboratory endpoints.
B Moderate * Based on either a self-evident conclusion; conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial.
C Optional 2 Based on published results of at least 1 well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes.
2† Extrapolated from published results of well-designed studies (including nonrandomized clinical trials) conducted in populations other than those specifically addressed by a recommendation. The source(s) of the extrapolated evidence and the rationale for the extrapolation are provided in the guideline text. One example would be results of studies conducted predominantly in a subpopulation (e.g., one gender) that the committee determines to be generalizable to the population under consideration in the guideline.
3 Based on committee expert opinion, with rationale provided in the guideline text.

Last updated on May 31, 2024