Diagnosis and Management of Acute HIV Infection

December 11, 2024

Purpose of This Guideline

Date of current publication: December 11, 2024
Lead author: Ethan Cowan, MD, MS
Writing group: Rona M. Vail, MD, AAHIVS; Sanjiv S. Shah, MD, MPH, AAHIVS; Steven M. Fine, MD, PhD; Joseph P. McGowan, MD, FACP, FIDSA, AAHIVS; Samuel T. Merrick, MD, FIDSA; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Anne K. Monroe, MD, MSPH; Jessica Rodrigues, MPH, MS; Christopher J. Hoffmann, MD, MPH, MSc, FACP; Brianna L. Norton, DO, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: August 24, 2018

This guideline on diagnosis and management of acute HIV infection was developed by the Medical Care Criteria Committee of New York State Department of Health AIDS Institute (NYSDOH AI) to guide clinicians in New York State who provide ambulatory, inpatient, and emergency medical care for adults aged ≥18 years who present with signs or symptoms of acute HIV infection or report an exposure within the past 4 weeks.

This guideline provides evidence-based clinical recommendations for the diagnosis and treatment of acute HIV infection in adults, with the goals of ensuring that New York State clinicians are able to:

  • Recognize the risks of and signs and symptoms of acute HIV, include HIV infection in the differential diagnosis, and consider HIV testing in any person who presents with signs and symptoms suggestive of influenza (“flu”), mononucleosis (“mono”), or other viral syndromes, including suspected COVID-19.
  • Perform appropriate diagnostic and confirmatory testing when HIV infection is suspected and manage the treatment of acute HIV.
  • Meet the New York State requirements for reporting and partner notification.
  • Recommend or offer immediate initiation of antiretroviral therapy (ART) to improve the patient’s health and reduce the risk of HIV transmission; refer and confirm that patients can access optimal HIV care.
  • Initiate or refer the patient for prevention services.
TERMINOLOGY
  • Acute HIV infection: Describes the period immediately after infection with HIV when an individual is viremic and has detectable p24 antigen or has HIV RNA without diagnostic HIV antibodies. In the medical literature, “primary HIV infection” may describe this same period.
  • Recent infection: Generally used to describe the 6-month period after infection occurs.
  • Early infection: May refer to acute or recent infection, after which infection is defined as chronic.

Early diagnosis for early treatment: Accumulating evidence supports a decision to begin HIV treatment at the time of diagnosis Crowell, et al. 2024; Gabert, et al. 2023; Chéret, et al. 2022; Dijkstra, et al. 2021; Lama, et al. 2021; Martin, et al. 2021; Lundgren, et al. 2015. Initiation of ART during acute infection may have several beneficial clinical outcomes, including improved preservation of immunologic function, significantly reduced time to viral suppression, and reduction of the viral reservoir, which could be important for cure strategies Pilcher, et al. 2017; Chéret, et al. 2015; Margolick, et al. 2015; Phanuphak, et al. 2015; Buzon, et al. 2014; Le, et al. 2013; Saez-Cirion, et al. 2013; Ananworanich, et al. 2012; Hocqueloux, et al. 2010; Koegl, et al. 2009; Streeck, et al. 2006; Pires, et al. 2004. The risk of sexual transmission of HIV during acute or recent infection is significantly higher than during chronic infection Hollingsworth, et al. 2015; Hollingsworth, et al. 2008; Pinkerton 2008; Pilcher, et al. 2004; this difference likely correlates with high levels of viremia. The public health benefit of early ART initiation is well documented, with a significant reduction of HIV transmission among virally suppressed individuals. Further, in September 2017, the NYSDOH endorsed the consensus from the Prevention Access Campaign that undetectable = untransmittable (“U = U”), which indicates that individuals with a durable (≥6 months) undetectable viral load will not sexually transmit HIV Prevention Access Campaign 2018; NYSDOH 2017.

Recognizing and diagnosing acute HIV infection is crucial to linking patients to care early and presents an important opportunity to reduce HIV transmission. Factors that may contribute to the increased risk of transmission during acute infection include:

For many reasons, detecting acute HIV infection is an essential link in the chain of prevention. Evidence demonstrates that patients with a recent diagnosis of HIV are more likely to reduce risk behaviors if they are given counseling at the time of testing Fonner, et al. 2012; Steward, et al. 2009 and are linked to primary HIV care Metsch, et al. 2008. In addition, for those who elect to initiate ART, their risk of transmission is significantly diminished Cohen, et al. 2016; Cohen, et al. 2011.

KEY POINTS
  • HIV is highly transmissible during acute infection; rapid initiation of antiretroviral therapy (ART) reduces transmission, with significant public health benefits; and early viral suppression preserves immune function, with significant clinical benefits for the individual with HIV.
  • Acute HIV often has nonspecific signs and symptoms and often goes unsuspected and undetected. This committee urges a high index of suspicion for acute infection and HIV testing for any individual who reports recent high-risk behavior or presents with signs or symptoms of influenza, mononucleosis, or other viral syndromes.
  • When HIV infection is diagnosed, immediate linkage to care is essential; ART dramatically reduces HIV-related morbidity and mortality, and viral suppression prevents HIV transmission.
  • The urgency of ART initiation is even greater if the newly diagnosed patient is pregnant, has acute HIV infection, is aged ≥50 years, or has advanced disease. For these patients, every effort should be made to initiate ART immediately, ideally on the same day as diagnosis.
  • All clinical care settings should be prepared, either on-site or with a confirmed referral, to support patients in initiating ART as rapidly as possible after diagnosis.
  • When a diagnosis of acute HIV infection is made, clinicians should discuss the importance of notifying all recent contacts and refer patients to partner notification services, as mandated by New York State law. The NYSDOH can provide assistance if necessary.
NEW YORK STATE LAW
  • Clinicians must perform diagnostic HIV laboratory tests in full compliance with New York State HIV/AIDS Laws and Regulations.
  • Clinicians must report confirmed cases of HIV according to New York State law (see NYSDOH HIV Reporting and Partner Services).
  • Additional information regarding testing procedures and regulations is available from the NYSDOH Wadsworth Center (518-474-2163).
  • Consent: HIV testing is voluntary. Although written or oral informed consent to HIV testing is not required in New York State, patients must be given the opportunity to decline. Healthcare providers must advise patients that an HIV test will be performed by giving notice orally, in writing, with prominently displayed signage, or using electronic means or other appropriate forms of communication. If the patient declines, it must be noted in the medical record. See New York State Senate Bill S7809.

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.

Presentation, Testing, and Diagnosis

RECOMMENDATIONS
Presentation of Acute HIV Infection
  • Clinicians should include acute HIV infection in the differential diagnosis for any patient who presents with signs or symptoms of influenza (“flu”), mononucleosis (“mono”), or other viral syndromes and reports sexual or parenteral exposure to a person with or at risk of HIV infection within the past month. (A2)
  • Clinicians should also include acute HIV infection in the differential diagnosis for any patient (regardless of reported risk) who presents with signs or symptoms of influenza (“flu”), mononucleosis (“mono”), or other viral syndromes (A3) and when the patient:
    • Presents with a rash. (A2)
    • Requests HIV testing. (A3)
    • Presents with a newly diagnosed STI. (A2)
    • Presents with aseptic meningitis. (A2)
    • Is pregnant or breastfeeding. (A3)
    • Is currently taking antiretroviral medications for PrEP or PEP. (A3)
Testing for Acute HIV Infection
  • Clinicians should always perform a plasma HIV RNA assay in conjunction with an Ag/Ab combination immunoassay when acute HIV is suspected [a]. (A2)
Diagnosis of Acute HIV Infection
  • Clinicians can presume the diagnosis of acute HIV when HIV RNA levels ≥200 copies/mL are detected in plasma with sensitive NAT, and the result of the HIV screening or type-differentiation test is negative or indeterminate. (A2)
  • When a low-level quantitative HIV RNA viral load result (<200 copies/mL) is obtained in the absence of serologic evidence of HIV infection, the clinician should repeat HIV RNA testing and perform an Ag/Ab combination immunoassay to exclude a false-positive result [b]. (A2)
  • Clinicians should seek expert consultation when an ambiguous HIV result is obtained for an individual taking PrEP or PEP because the diagnosis of acute HIV can be particularly challenging. (A3)
ART Initiation
  • If a diagnosis of acute infection is made based on HIV RNA testing, clinicians should recommend ART initiation without waiting for serologic confirmation. (A2)
Partner Notification

Abbreviations: Ab, antibody; Ag, antigen; ART, antiretroviral therapy; NAT, nucleic acid test; PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection.

Notes:

  1. When point-of-care screening is performed, even with a rapid Ag/Ab combination immunoassay, a laboratory-based Ag/Ab combination immunoassay is recommended for follow-up diagnostic HIV testing.
  2. A serologic test result that does not meet the criteria for HIV infection is a nonreactive screening result (Ab or Ag/Ab combination) or a reactive screening result with a nonreactive or indeterminate Ab differentiation confirmatory result.

The time from HIV infection to detection of the virus depends on the test that is used. Figure 1, below, illustrates the window of detection of HIV infection according to Ab, Ag/Ab combination, and HIV RNA tests.

Figure 1: HIV Test Window of Detection [a,b,c]

Figure 1: HIV Test Window of Detection [a,b,c]

Abbreviations: IgG, immunoglobulin G; IgM, immunoglobulin M; NAT, nucleic acid test; PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis.

Notes:

  1. Figure reproduced from CDC: Clinical Testing Guidance for HIV.
  2. Without PrEP or PEP exposure; PrEP or PEP exposure may delay seroconversion. Very early treatment of acute HIV infection may also alter the serologic response Stekler, et al. 2023; Hare, et al. 2006; Kassutto, et al. 2005.
  3. The eclipse period is the time from the onset of HIV infection until the virus is detectable by virologic tests.

Download figure: HIV Test Window of Detection

Presentation

The presentation of acute HIV infection is highly variable. Fever and influenza- or mononucleosis-like symptoms are common in acute HIV infection but are nonspecific. Patients may also present with more specific symptoms of acute retroviral syndrome (see Box 1, below) such as rash, mucocutaneous ulcers, oropharyngeal candidiasis, lymphadenopathy and meningismus, which should raise the index of suspicion. The mean time from exposure to onset of symptoms is generally 2 to 4 weeks, with a range of 5 to 29 days; however, some cases have presented with symptoms up to 3 months after exposure Apoola, et al. 2002. This time course is prolonged and atypical in patients who become infected while on PEP or PrEP Landovitz, et al. 2024; Moschese, et al. 2024.

Box 1: Acute Retroviral Syndrome

Signs and symptoms of ARS with the expected frequency among symptomatic patients are listed below [a]. The most specific symptoms in this study were oral ulcers and weight loss; the best predictors were fever and rash. The index of suspicion should be high when these symptoms are present.

  • Fever (80%)
  • Tired or fatigued (78%)
  • Malaise (68%)
  • Arthralgias (joint pain) (54%)
  • Headache (54%)
  • Loss of appetite (54%)
  • Rash (51%)
  • Night sweats (51%)
  • Myalgias (pain in muscles) (49%)
  • Nausea (49%)
  • Diarrhea (46%)
  • Fever and rash (46%)
  • Pharyngitis (sore throat) (44%)
  • Lymphadenopathy (39%)
  • Oral ulcers (mouth sores) (37%)
  • Stiff neck (34%)
  • Weight loss (>5 lb; 2.5 kg) (32%)
  • Confusion (25%)
  • Photophobia (24%)
  • Vomiting (12%)
  • Infected gums (10%)
  • Sores on anus (5%)
  • Sores on genitals (2%)

Note:

  1. Data adapted from Suanzes, et al. 2023; Hecht, et al. 2002.

Testing and Diagnosis

Acute HIV infection is often not recognized in the primary care setting because the symptom profile is similar to that of influenza, mononucleosis, and other common illnesses. Furthermore, patients often do not recognize that they may have recently been exposed to HIV. Therefore, the clinician should have a high index of suspicion for acute HIV infection in a patient who may have recently engaged in behavior involving sexual or parenteral exposure to another individual’s blood or body fluids and who is presenting with a febrile, influenza-, or mononucleosis-like illness. Identifying acute HIV infection during pregnancy is particularly important because effective intervention can prevent mother-to-child transmission Patterson, et al. 2007.

High levels of HIV RNA detected in plasma through sensitive NAT, combined with a negative or indeterminate HIV screening or type-differentiation test, support the presumptive diagnosis of acute HIV infection DHHS 2024; Robb, et al. 2016. Reflex testing to HIV RNA when there are discordant results between an Ag/Ab combination immunoassay followed by a negative or indeterminate Ab differentiation immunoassay can both help to identify acute HIV infection and mitigate the need for the patient to return for confirmatory testing Kaperak, et al. 2024. While both quantitative and qualitative HIV-1 RNA assays have good sensitivity for detecting HIV-1 at a low threshold, quantitative tests are more widely available and preferred Wu, et al. 2017. An elevated signal-to-cutoff ratio (≥10) on laboratory-performed Ag/Ab combination immunoassays may help differentiate between acute HIV infection and a false-positive result Crowell, et al. 2021; Li, et al. 2018; Jensen, et al. 2015.

When low-level viremia is reported by HIV RNA testing (<200 copies/mL) in the absence of serologic confirmation of HIV infection, HIV RNA testing should be repeated to exclude a false-positive result Hecht, et al. 2002. Repeat HIV RNA testing with a result that indicates the presence of low-level viremia may represent true HIV infection, warranting appropriate counseling regarding transmission risk and initiation of ART.

HIV RNA levels tend to be very high in acute infection; however, a low value may represent any point on the upward or downward slope of the viremia associated with acute infection or could simply represent chronic infection. HIV RNA can also be suppressed during acute infection in patients who are taking PrEP. For patients taking long-acting injectable cabotegravir (CAB-LA) for PrEP, laboratory and clinical presentation of acute HIV infection can be difficult to interpret due to long-acting early viral inhibition (also known as LEVI syndrome) Landovitz, et al. 2024. Observation and frequent retesting may be needed to determine whether HIV infection has occurred in these patients, and consultation with an experienced HIV care provider is advised.

Plasma HIV RNA levels during acute infection do not appear significantly different in patients who are and are not symptomatic Patterson, et al. 2007. Viremia occurs approximately 1 to 2 weeks before the detection of a specific immune response. Patients diagnosed with acute infection by HIV RNA testing should always receive follow-up diagnostic testing 3 weeks later to confirm infection (see the standard HIV laboratory testing algorithm). Figure 2, below, illustrates diagnostic testing for acute HIV infection.

KEY POINTS
  • The diagnosis of acute HIV infection requires a high degree of clinical awareness. The nonspecific signs and symptoms of acute HIV infection are often not recognized or attributed to another viral illness.
  • Individual laboratories have internal protocols for reporting HIV tests with preliminary results. The terms used when preliminary results cannot be classified include indeterminate, inconclusive, nondiagnostic, and pending validation. Clinicians can contact the appropriate laboratory authority to determine the significance of nondefinitive results and the recommended supplemental testing, particularly when acute HIV infection is suspected. Clinicians are advised to become familiar with the internal test-reporting policies of their institutions.

Figure 2: Diagnostic Testing for Acute HIV Infection

Figure 2: Diagnostic Testing for Acute HIV Infection

Notes:

  1. Viremia will be present several days prior to p24 antigen detection and several weeks before antibody detection.
  2. HIV RNA quantitative testing is preferred.
  3. The absence of serologic evidence of HIV infection is defined as nonreactive screening result (antibody or antibody/antigen combination) or a reactive screening result with a nonreactive or indeterminate antibody-differentiation confirmatory result.
  4. Serologic confirmation as defined by the Centers for Disease Control and Prevention HIV testing algorithm. Western blot is no longer recommended as the confirmatory test because it may yield an indeterminate result during the early stages of seroconversion and may delay confirmation of diagnosis.
  5. No further testing is indicated.

Download figure: Diagnostic Testing for Acute HIV Infection

Management, Including While on PEP or PrEP

RECOMMENDATIONS
Managing Acute HIV Infection
  • Clinicians should recommend immediate ART initiation to all patients diagnosed with acute HIV infection. (A1)
  • Clinicians should inform patients that the risk of transmitting HIV is increased during acute infection and the 6 months following infection and continues beyond 6 months [a] (A2).
  • As part of the initial management of patients diagnosed with acute HIV infection, clinicians should:
    • Consult with a care provider experienced in the treatment of acute HIV infection. (A3)
    • Obtain HIV genotypic resistance testing for the protease (A2), reverse transcriptase (A2), and integrase (B2) genes at the time of diagnosis.
  • Patients taking PEP: When acute HIV infection is diagnosed in an individual receiving PEP, ART should be continued pending consultation with an experienced HIV care provider. (A3)
  • Patients taking PrEP: Because the risk of drug-resistant mutations is higher in patients who acquire HIV while taking PrEP, clinicians should consult with an experienced HIV care provider and recommend a fully active ART regimen. (A3)
    • Clinicians who do not have access to experienced HIV care providers should call the Clinical Education Initiative (CEI) Line at 866-637-2342.
Initiating ART
  • When a patient agrees with the clinician’s recommendation to initiate ART during acute HIV infection:
    • The clinicians should implement treatment to suppress the patient’s plasma HIV RNA to below detectable levels. (A1)
    • Clinicians should perform baseline laboratory testing for all patients initiating ART immediately; ART can be started while awaiting laboratory test results. (A3)

Abbreviations: ART, antiretroviral therapy; PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis.

Note:

  1. Only individuals with a durable (≥6 months) undetectable viral load will not sexually transmit HIV (see NYSDOH AI U=U Guidance for Implementation in Clinical Settings).

Patients are at greatest risk of transmitting HIV during periods of high viremia early in infection. Clinicians should counsel patients with acute HIV about the increased risk of transmission during the 6 months after acute infection and the ongoing risk of transmission beyond 6 months. Partner notification Golden, et al. 2004, counseling on safer sex, and screening for other sexually transmitted infections are all essential in the management of any new HIV diagnosis.

Consultation: When choosing an ART regimen for a patient with acute HIV infection, clinicians should consult a care provider experienced in treating acute HIV infection.

  • Data are insufficient to support a specific ART regimen(s) for the treatment of acute HIV infection; instead, the choice of regimen should be made based on recommendations for selecting an initial ART regimen.
  • The risks of transmitted resistance should be considered when prescribing ART while awaiting HIV resistance results.
  • The risks of acquired mutations should be considered in those who acquire HIV while on PrEP.
  • Clinicians who do not have access to experienced HIV care providers should call the CEI Line at 866-637-2342.

All Recommendations

ALL RECOMMENDATIONS: DIAGNOSIS AND MANAGEMENT OF ACUTE HIV INFECTION
Presentation of Acute HIV Infection
  • Clinicians should include acute HIV infection in the differential diagnosis for any patient who presents with signs or symptoms of influenza (“flu”), mononucleosis (“mono”), or other viral syndromes and reports sexual or parenteral exposure to a person with or at risk of HIV infection within the past month. (A2)
  • Clinicians should also include acute HIV infection in the differential diagnosis for any patient (regardless of reported risk) who presents with signs or symptoms of influenza (“flu”), mononucleosis (“mono”), or other viral syndromes (A3) and when the patient:
    • Presents with a rash. (A2)
    • Requests HIV testing. (A3)
    • Presents with a newly diagnosed STI. (A2)
    • Presents with aseptic meningitis. (A2)
    • Is pregnant or breastfeeding. (A3)
    • Is currently taking antiretroviral medications for PrEP or PEP. (A3)
Testing for Acute HIV Infection
  • Clinicians should always perform a plasma HIV RNA assay in conjunction with an Ag/Ab combination immunoassay when acute HIV is suspected [a]. (A2)
Diagnosis of Acute HIV Infection
  • Clinicians can presume the diagnosis of acute HIV when HIV RNA levels ≥200 copies/mL are detected in plasma with sensitive NAT, and the result of the HIV screening or type-differentiation test is negative or indeterminate. (A2)
  • When a low-level quantitative HIV RNA viral load result (<200 copies/mL) is obtained in the absence of serologic evidence of HIV infection, the clinician should repeat HIV RNA testing and perform an Ag/Ab combination immunoassay to exclude a false-positive result [b]. (A2)
  • Clinicians should seek expert consultation when an ambiguous HIV result is obtained for an individual taking PrEP or PEP because the diagnosis of acute HIV can be particularly challenging. (A3)
ART Initiation
  • If a diagnosis of acute infection is made based on HIV RNA testing, clinicians should recommend ART initiation without waiting for serologic confirmation. (A2)
Partner Notification
Managing Acute HIV Infection
  • Clinicians should recommend immediate ART initiation to all patients diagnosed with acute HIV infection. (A1)
  • Clinicians should inform patients that the risk of transmitting HIV is increased during acute infection and the 6 months following infection and continues beyond 6 months [c] (A2).
  • As part of the initial management of patients diagnosed with acute HIV infection, clinicians should:
    • Consult with a care provider experienced in the treatment of acute HIV infection. (A3)
    • Obtain HIV genotypic resistance testing for the protease (A2), reverse transcriptase (A2), and integrase (B2) genes at the time of diagnosis.
  • Patients taking PEP: When acute HIV infection is diagnosed in an individual receiving PEP, ART should be continued pending consultation with an experienced HIV care provider. (A3)
  • Patients taking PrEP: Because the risk of drug-resistant mutations is higher in patients who acquire HIV while taking PrEP, clinicians should consult with an experienced HIV care provider and recommend a fully active ART regimen. (A3)
    • Clinicians who do not have access to experienced HIV care providers should call the Clinical Education Initiative (CEI) Line at 866-637-2342.
Initiating ART
  • When a patient agrees with the clinician’s recommendation to initiate ART during acute HIV infection:
    • The clinicians should implement treatment to suppress the patient’s plasma HIV RNA to below detectable levels. (A1)
    • Clinicians should perform baseline laboratory testing for all patients initiating ART immediately; ART can be started while awaiting laboratory test results. (A3)

Abbreviations: Ab, antibody; Ag, antigen; ART, antiretroviral therapy; NAT, nucleic acid test; PEP, post-exposure prophylaxis; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection.

Notes:

  1. When point-of-care screening is performed, even with a rapid Ag/Ab combination immunoassay, a laboratory-based Ag/Ab combination immunoassay is recommended for follow-up diagnostic HIV testing.
  2. A serologic test result that does not meet the criteria for HIV infection is a nonreactive screening result (Ab or Ag/Ab combination) or a reactive screening result with a nonreactive or indeterminate Ab differentiation confirmatory result.
  3. Only individuals with a durable (≥6 months) undetectable viral load will not sexually transmit HIV (see NYSDOH AI U=U Guidance for Implementation in Clinical Settings).

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

Rationale

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.

Benefits

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]

Approach

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.

SHARED DECISION-MAKING IN HIV CARE
  • 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.

RESOURCES
References

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]

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Updates, Authorship, and Related Guidelines

Updates, Authorship, and Related Guidelines
Date of original publication August 24, 2018
Date of current publication December 11, 2024
Highlights of changes, additions, and updates in the December 11, 2024 edition
  • Purpose of This Guideline section: Consent language for HIV testing updated according to New York State law
  • Presentation section:
    • Recommendations on presentation of acute HIV infection divided to address patients who report sexual or parenteral exposure to a person with or at risk of HIV infection within the past month and patients regardless of reported risk
    • Box 1: Acute Retroviral Syndrome: Updated to include lymphadenopathy
  • Testing and Diagnosis section:
    • Recommendation on plasma HIV RNA testing revised to include “when acute HIV is suspected.”
    • Recommendations on diagnosis of acute HIV infection revised to 1) update plasma HIV RNA level at which clinicians can presume a diagnosis of acute HIV (see also Figure 2) and 2) include the potential challenge of diagnosing acute HIV in patients taking PEP
    • Supplemental text revised to state a preference for qualitative vs quantitative plasma HIV RNA testing in the diagnostic process (see also Figure 2)
    • Supplemental text added on the laboratory and clinical presentation of acute HIV infection in patients taking long-acting injectable cabotegravir for PrEP
  • Updated citations and references throughout the guideline
Intended users Clinicians in New York State who provide ambulatory, inpatient, and emergency medical care for adults aged ≥18 years who present with signs or symptoms of acute HIV infection or report an exposure within the past 4 weeks
Lead author

Ethan Cowan, MD, MS
Writing group

Rona M. Vail, MD, AAHIVS; Sanjiv S. Shah, MD, MPH, AAHIVS; Steven M. Fine, MD, PhD; Joseph P. McGowan, MD, FACP, FIDSA, AAHIVS; Samuel T. Merrick, MD, FIDSA; Asa E. Radix, MD, MPH, PhD, FACP, AAHIVS; Anne K. Monroe, MD, MSPH; Jessica Rodrigues, MPH, MS; Christopher J. Hoffmann, MD, MPH, MSc, FACP; Brianna L. Norton, DO, MPH; Charles J. Gonzalez, MD
Author and writing group conflict of interest disclosures There are no author or writing group conflict of interest disclosures.
Committee

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

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 December 17, 2024