Purpose of This Guideline
Date of current publication: December 15, 2022
Lead authors: Mary Dyer, MD, and Christine Kerr, MD
Writing group: Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa 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. 2017; Samji, et al. 2013; Zwahlen, 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. 2015; El-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. 2009; Emery, 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||
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. 2015; Deeks 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. 2020; Bourgi(b), et al. 2020 and osteoporosis Komatsu, et al. 2018; Grigsby, et al. 2010.
Patients with CD4 count <200 cells/mm3: Morbidity and mortality are increased in individuals with low CD4 cell counts Castilho, et al. 2022; Althoff, et al. 2019; May, 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. 2018; Serrano-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. 2018; Collazos, 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 guideline: This 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.
- Table 1: HIV, Medications, and General Medical Status and History for Adults With HIV
- Table 2: Psychosocial, Behavioral Health, Sexual Health, and Well-Being Assessment of Adults With HIV
- Table 3: Recommended Laboratory Testing for Adults With HIV
- Table 4: Routine Screening for Adults With HIV
- Table 5: Primary Prevention for Adults With HIV
- Table 6: Prophylaxis for Opportunistic Infections in Adults With HIV
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. 2018; Rhodes, et al. 2017; Kerr, et al. 2012; Landon, 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. 2017; Chambers, 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. 2018; Miller, 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. 2016; Metsch, 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. 2020; Sherr, et al. 2011. See the following for more information:
- New York State Office of Mental Health: Recovery from Trauma
- New York State Trauma-Informed Network
- Trauma Informed Care in Medicine: Current Knowledge and Future Research Directions (article) Raja, et al. 2015
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. 2006; Thio, et al. 2002; Graham, et al. 2001; Benhamou, 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).
|RESOURCES: ART DRUG-DRUG INTERACTIONS|
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. 2017; Chiarella and Grammer 2017; Small 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. 2018; Sorensen 2011; Epstein 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. 2019; Erdmann, 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. 2019; Green, 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-Cog, and 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 2017; Triant 2013; Islam, et al. 2012; Shiels, et al. 2011; Bower, et al. 2009; Crothers, 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. 2019; Trickey, et al. 2016; Helleberg, 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. 2018; Gazzaruso, 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 Assessment, Mini-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
|Current HIV-Specific Status and History|
|CD4 cell count||
|Complete medication list||
|Current General Medical Status and History|
|Age-related disease screening||
|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
|Gender and Sexual Identity|
|Current sexual identity||
|Inventory of sexual organs||
|Current Psychosocial Status and History|
|Family and other significant relationships and responsibilities||
|Interpersonal and social support network||
|Current Mental Health Status and History|
|Current Substance Use and History|
|Tobacco use and vaping||
|Use of nonprescription drugs and misuse of prescribed drugs||
|Sexual and Reproductive Health and History|
|Sex partner(s) and activity||
|Sexually transmitted infections||
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
|HIV-1 RNA quantitative viral load||
|CD4 lymphocyte count||
|HIV-1 resistance testing (genotypic)||
|Complete blood count||
|Estimated glomerular filtration rate||
|Random blood glucose (fasting or hemoglobin A1C if high)||
|Urine pregnancy test||
|Serum thyroid-stimulating hormone||
|Gonorrhea and chlamydia||
Routine Screening and Primary Prevention
Routine Screening and Primary Prevention
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.
|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]||
|Colon cancer [c]||USPSTF: Colorectal Cancer: Screening (2021)||
|Cervical cancer [c]||NYSDOH AI: Screening for Cervical Dysplasia and Cancer in Adults With HIV (2022)||
|Anal dysplasia and cancer||NYSDOH AI: Screening for Anal Dysplasia and Cancer in Patients With HIV (2022)||
|Lung cancer [c]||USPSTF: Lung Cancer: Screening (2021)||
|Prostate cancer [c]||USPSTF: Prostate Cancer: Screening (2018)||
|Bone density||USPSTF: Osteoporosis to Prevent Fractures: Screening (2018)||
|Abdominal aortic aneurysm||USPSTF: Abdominal Aortic Aneurysm: Screening (2019)||
|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|
|Tobacco smoking||USPSTF: Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions (2021)||
|Unhealthy alcohol and drug use||NYSDOH AI: Substance Use Screening and Risk Assessment in Adults (2020)||
|Depression||USPSTF: Screening for Depression in Adults (2016)|
|Domestic violence||USPSTF: Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening (2018)||
|Sexually transmitted infections||USPSTF: Sexually Transmitted Infections: Behavioral Counseling (2020)||
|Neural tube defects in pregnancy||USPSTF: Folic Acid for the Prevention of Neural Tube Defects: Preventive Medication (2017)||
|Breast cancer||USPSTF: Breast Cancer: Medication Use to Reduce Risk (2019)||
|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)||
Prevention of Opportunistic Infections
Prevention of Opportunistic Infections
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. 2017; Ransome, 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.
|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||
|Cytomegalovirus||Primary prophylaxis is not routinely recommended.||N/A||
|Mycobacterium avium complex||
|Pneumocystis jiroveci pneumonia
(formerly Pneumocystis carinii pneumonia)
|Toxoplasma gondii encephalitis [a,c]||
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: COMPREHENSIVE PRIMARY CARE FOR ADULTS WITH HIV|
History, Assessment, and Evaluation
Routine Screening and Primary Prevention
Prevention of Opportunistic Infections
Abbreviations: ART, antiretroviral therapy; G6PD, glucose-6-phosphate dehydrogenase; OI, opportunistic infection.
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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||
|Intended users||New York State clinicians who provide primary care for adults with HIV|
Mary Dyer, MD; Christine Kerr, MD
Joseph P. McGowan, MD, FACP, FIDSA; Steven M. Fine, MD, PhD; Rona Vail, MD; Samuel T. Merrick, MD; Asa Radix, MD, MPH, PhD, FACP, AAHIVS; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
|Author and writing group conflict of interest disclosures||There are no author or writing group conflict of interest disclosures|
|Developer and funder|
See Guideline Development and Recommendation Ratings Scheme, below.
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.|
|Disclosure and management of conflicts of interest||
|Evidence collection and review||
|Review and approval process||
|Recommendation Ratings Scheme|
|Strength||Quality of Evidence|
|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.|