Purpose of This Guideline
Date of current publication: June 20, 2023
Lead author: Sanjiv S. Shah, MD, MPH, AAHIVS
Writing group: Steven M. Fine, MD, PhD; Rona M. Vail, MD; Joseph P. McGowan, 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: July 8, 2019
The New York State Department of Health AIDS Institute (NYSDOH AI) developed this guideline for primary care providers and other clinicians who may diagnose and treat adults with HIV-2 infection. The guideline is designed to achieve the following goals:
- Inform clinicians about when to suspect and how to diagnose and manage the care of adults with HIV-2.
- Identify the similarities and differences in treatment for patients with HIV-1 and HIV-2.
- Recommend preferred antiretroviral (ARV) regimens for treatment and identify ARVs to avoid.
- Encourage clinicians to use the services of the NYSDOH Wadsworth Center, the New York State public health laboratory, for testing used in monitoring HIV-2.
- Integrate current evidence-based clinical recommendations into the healthcare-related implementation strategies of the Ending the Epidemic (ETE) initiative, which seeks to end the AIDS epidemic in New York State.
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.
The HIV-2 virus was first isolated in West Africa in the mid-1980s among individuals with AIDS Clavel, et al. 1986. HIV-2 infection is endemic in West Africa, with the highest prevalence in Cape Verde, the Ivory Coast, Gambia, Guinea-Bissau, Mali, Mauritania, Nigeria, and Sierra Leone Gottlieb, et al. 2018. Although rare, HIV-2 infection has also been reported in several countries in Europe, South America, and Asia and in the United States UpToDate 2023. A surveillance report covering the period 1987 to 2009 identified 166 cases of HIV-2 in the United States; 46% of those were from New York City CDC 2011. The majority of individuals with HIV-2 were from West Africa or had sexual contact or shared injection drug equipment with someone from this region Torian, et al. 2010. A subsequent HIV testing surveillance analysis covering the period 2010 to 2017 reported that among 327,700 HIV cases diagnosed in the United States, 102 were confirmed HIV-2 infections and 11 were dual HIV-1/HIV-2 infections Peruski, et al. 2020. The report also confirmed that the cases of HIV-2 were diagnosed predominantly in people from West Africa who were living in the northeast United States and had acquired HIV-2 through heterosexual transmission. The number of HIV-2 cases was proportionate between males and females Peruski, et al. 2020. An analysis of New York State surveillance data covering the period 2010 to 2020 found that among 34,949 diagnosed HIV cases, 43 had HIV-2 infection, 3 had dual HIV-1/HIV-2 infection, and 25 had probable HIV-2 infection. Among the 71 HIV-2 cases, 54% were male, 79% were non-Hispanic Black, and 31% were ≥55 years old at diagnosis NYSDOH 2022.
HIV-2 infection is associated with slower disease progression than HIV-1 infection because of lower plasma viral load levels of HIV-2 van der Loeff, et al. 2010; MacNeil, et al. 2007; Gottlieb, et al. 2002; Popper, et al. 1999; Simon, et al. 1993. With lower levels of virus, HIV-2 is transmitted less efficiently than HIV-1 through sexual behavior and from mother to child Burgard, et al. 2010; O'Donovan, et al. 2000; Adjorlolo-Johnson, et al. 1994. Similar to HIV-1, HIV-2 disease progression correlates with increasing plasma HIV-2 viral load Gottlieb, et al. 2002. Although HIV-2 is less virulent than HIV-1, individuals with HIV-2 manifest clinical signs, symptoms, and opportunistic infections (OIs) similar to those seen with HIV-1. Elevated markers of B-cell perturbations and colonic damage were observed in treatment-naive individuals with HIV-2 and no detectable virus; these findings were not observed in antiretroviral therapy (ART)-treated individuals with HIV-1 and viral suppression Johansson, et al. 2023. In addition, the majority of individuals with HIV-2, if untreated, will eventually progress to AIDS and death Esbjornsson, et al. 2019.
There are many similarities in the management of patients with HIV-1 and those with HIV-2, including prophylaxis for and treatment of OIs and timing of antiretroviral therapy (ART) initiation. As noted in the guideline section Treatment of HIV-2, ART should be recommended for all individuals diagnosed with HIV-2 Ba, et al. 2018. As with HIV-1, the patient should make the final decision of whether and when to initiate ART.
A key difference in the clinical management of HIV-2 compared with HIV-1 is that resistance testing is not commercially available in the United States and guidance in interpreting mutations is not readily available for HIV-2. Another important difference in management is that the non-nucleoside reverse transcriptase inhibitor class of ARV medications is not effective against HIV-2. Furthermore, unlike in HIV-1, there are no randomized clinical trials of ARV treatment for HIV-2 that indicate the optimal time to initiate treatment or the preferred initial regimen. Therefore, treatment recommendations for HIV-2 are in large part derived from clinical studies conducted on HIV-1. Because HIV-1 and HIV-2 share the same pathogenic process, extrapolating to HIV-2 from HIV-1 is a clinically valid approach.
Diagnosis of HIV-2
Diagnosis of HIV-2
Abbreviations: Ab, antibody; Ag, antigen; FDA, U.S. Food and Drug Administration.
Before the HIV-1/2 Ag/Ab combination and HIV-1/HIV-2 Ab differentiation immunoassays for HIV testing became widely available, clinicians suspected chronic HIV-2 infection in certain clinical scenarios, such as a declining CD4 count in an HIV-1-seropositive, untreated individual with an undetectable HIV-1 plasma viral load or an opportunistic infection in an individual from West Africa who is not HIV-1 seropositive.
Currently, all HIV testing performed according to the Centers for Disease Control and Prevention (CDC)/Association of Public Health Laboratories algorithm begins with an FDA-approved HIV-1/2 Ag/Ab combination immunoassay CDC 2018, which detects HIV-1 p24 Ag and HIV-1 and HIV-2 antibodies but not HIV-2 Ag. If the combination immunoassay is reactive, a supplemental HIV-1/HIV-2 Ab differentiation immunoassay is performed. Clinicians should consider HIV-2 infection in the 4 scenarios described below.
- HIV-1/HIV-2 differentiation immunoassay is reactive for HIV-2 Ab: The individual is considered HIV-2 Ab positive, and a clinical evaluation for HIV-2 infection should be performed (see guideline section Treatment of HIV-2).
- HIV-1/HIV-2 differentiation immunoassay is reactive for HIV-1 and HIV-2 Ab: The individual is considered HIV positive, undifferentiated, and HIV-1 RNA and HIV-2 RNA or DNA testing should be performed to confirm or exclude HIV-1/HIV-2 coinfection. A minority of individuals with HIV-2 are coinfected with HIV-1. Qualitative and quantitative HIV-2 viral load testing is available by contacting the Wadsworth Center Bloodborne Viruses Laboratory (see Box 1, below).
- HIV-1/HIV-2 differentiation immunoassay is nonreactive or indeterminate for HIV-1 and/or HIV-2 Ab: Plasma HIV-1 RNA testing should be performed to confirm or exclude acute HIV-1 infection CDC 2018.
- If the Ab differentiation immunoassay is nonreactive or HIV-1 indeterminate and HIV-1 RNA is not detected, the individual is considered negative for HIV-1 and HIV-2.
- If the Ab differentiation immunoassay is either HIV-2 indeterminate or HIV indeterminate and HIV-1 RNA is not detected, then HIV-2 RNA testing may be used to confirm HIV-2 infection. However, because HIV-2 RNA levels can be low or undetectable in an individual with HIV-2 infection, the absence of HIV-2 RNA does not exclude HIV-2 infection. Therefore, in an individual at high risk of HIV-2 infection who has undetectable HIV-2 RNA, clinicians should consider testing for HIV-2 DNA or repeating the HIV testing algorithm in 2 to 4 weeks, starting with the HIV-1/2 Ag/Ab combination immunoassay. If results remain unclear, clinicians may consider obtaining other HIV-2-specific tests through public health or commercial laboratories or the CDC.
- Nonreactive HIV-1/2 Ag/Ab combination immunoassay and suspected recent exposure to HIV-2 (e.g., exposure from a sex partner from an HIV-2 endemic area): HIV-2 RNA testing may be required or the HIV testing algorithm may be repeated, beginning with the HIV-1/2 Ag/Ab combination immunoassay, 4 weeks (and not later than 12 weeks) after the first test.
|Box 1: Wadsworth Center Bloodborne Viruses Laboratory||
Treatment of HIV-2
Treatment of HIV-2
Abbreviations: ART, antiretroviral therapy; INSTI, integrase strand transfer inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside/nucleotide reverse transcriptase inhibitor.
|Abbreviations: Al, aluminum; ART, antiretroviral therapy; Ca, calcium; CrCl, creatinine clearance; Mg, magnesium.
|Table 1: Preferred ART Regimens for Initial Treatment of Nonpregnant Adults With HIV-2 [a]
(listed alphabetically; for specific details, see drug package inserts; for full recommendations on initiating ART in patients with HIV-1, see the NYSDOH AI guideline Selecting an Initial ART Regimen)
|Available as a Single-Tablet Formulation|
dolutegravir [b,c] (ABC/3TC/DTG; Triumeq)
emtricitabine/ bictegravir [c] (TAF 25 mg/FTC/BIC; Biktarvy)
|Available as a Multi-Tablet Regimen With Once-Daily Dosing|
tenofovir disoproxil fumarate/ emtricitabine and dolutegravir [b,c] (TAF 25 mg/FTC or TDF 300 mg/FTC and DTG; Descovy or Truvada and Tivicay)
tenofovir disoproxil fumarate/ emtricitabine and raltegravir [c] (TAF 25 mg/FTC or TDF 300 mg/FTC and RAL HD; Descovy or Truvada and Isentress HD)
|Abbreviations: Al, aluminum; ART, antiretroviral therapy; Ca, calcium; CrCl, creatinine clearance; Mg; magnesium.
|Table 2: Alternative ART Regimens for Initial Treatment of Nonpregnant Adults With HIV-2 [a]
(listed alphabetically; for specific details, see drug package inserts; for full recommendations on initiating ART in patients with HIV-1, see the NYSDOH AI guideline Selecting an Initial ART Regimen)
|Available as a Single-Tablet Formulation|
cobicistat [b] (TAF 10 mg/FTC/DRV/COBI; Symtuza)
cobicistat [b] (TAF 10 mg/FTC/EVG/COBI; Genvoya)
|Available as a Multi-Tablet Regimen With Twice-Daily Dosing|
tenofovir disoproxil fumarate/emtricitabine and raltegravir [b] (TAF 25 mg/FTC or TDF 300 mg/FTC and RAL; Descovy or Truvada and Isentress)
Resistance testing: Although baseline genotypic drug resistance testing is recommended for all individuals with HIV-1 before ART initiation, HIV-2 resistance tests are not commercially available in the United States.
ART regimen options: All U.S. Food and Drug Administration-approved NRTIs effectively inhibit HIV-2 reverse transcriptase Menendez-Arias and Alvarez 2014. Three HIV protease inhibitors (PIs) effectively inhibit HIV-2, but given the availability of darunavir (DRV), the use of lopinavir and saquinavir should be limited. Atazanavir, fosamprenavir, tipranavir, and nelfinavir have no or greatly reduced in vitro inhibitory activity against HIV-2. As a class, NNRTIs are not active against HIV-2 Menendez-Arias and Alvarez 2014.
Based on limited clinical trial data using the INSTIs elvitegravir and raltegravir (RAL), retrospective observational studies with other INSTIs, and in vitro data, it is expected that INSTIs as a class are active against HIV-2, and a dolutegravir (DTG)- or bictegravir (BIC)-based regimen with 2 NRTIs can be used to treat treatment-naive patients with HIV-2. In one study of a single-tablet regimen (elvitegravir/cobicistat/tenofovir disoproxil fumarate/emtricitabine [EVG/COBI/TDF/FTC]), 93.3% of subjects had viral suppression at 48 weeks Ba, et al. 2018. A study of a multi-tablet regimen (TDF/FTC and RAL) demonstrated that 96% of participants with HIV-2 completing the 48-week follow-up had an HIV-2 viral load <40 copies/mL Matheron, et al. 2018. A retrospective observational study from Spain among participants with HIV-2 reported that after approximately 13 months of follow-up on INSTI-based regimens (including DTG), 89% of treatment-naive and 65% of treatment-experienced participants achieved an undetectable viral load Requena, et al. 2019. A similar study from India showed that on a DTG-based regimen, 86% of treatment-naive participants with HIV-2 achieved an undetectable viral load Pujari, et al. 2020 However, without genotypic resistance testing, the 2-drug regimen of lamivudine/DTG should not be used by patients with HIV-2 because using this regimen requires advance confirmation that they do not have virus with the M184V mutation.
In treatment-experienced patients with HIV-2, the antiretrovirals (ARVs) listed in Tables 1 and 2, above, can be considered if their potency has not been compromised by prior treatment failure and the likely emergence of drug resistance/cross-resistance. There are no commercially available genotypic or phenotypic drug resistance assays for HIV-2 available in the United States that can be used to guide the selection of an alternative ART regimen in cases of virologic failure. Algorithms are available to interpret HIV-2 genetic sequences obtained from research laboratories for the presence of resistance-associated mutations and coreceptor use; however, clinical decisions should not be made solely on these predictions. See:
- Stanford University HIV Resistance Database: HIVdb Program for HIV-2 (beta)
- Collaborative HIV and Anti-HIV Drug Resistance Network: HIV2EU Algorithm
- Max Planck Institute for Informatics: Geno2pheno [coreceptor-hiv2] 1.0
BIC is highly potent against HIV-2 in vitro Le Hingrat, et al. 2019; Smith, et al. 2019; Tsiang, et al. 2016. Preliminary findings from a small observational study indicate the regimen is well tolerated and effective in achieving or maintaining HIV-2 suppression Joly, et al. 2023. If no drug resistance testing is available, DTG and BIC should be used with caution in treatment-experienced patients with HIV-2 who have virologic failure on a RAL- or EVG-based ART regimen.
The chemokine receptor antagonist maraviroc (MVC) is active against HIV-2 strains that exclusively use CCR5 for viral entry Borrego, et al. 2012. However, its use in the treatment of HIV-2 is limited because there is no commercially available tropism assay for HIV-2 to predict susceptibility to MVC.
Ibalizumab (IBA), a humanized monoclonal IgG-4 antibody that prevents HIV cell entry by binding to the host CD4 receptor, has in vitro evidence of activity against HIV-2 with IC50 levels comparable to those found in HIV-1 group M strains Le Hingrat, et al. 2022. However, the in vivo efficacy of an IBA-containing regimen in individuals with ARV-resistant HIV-2 infection has not been established.
Lenacapavir (LEN), a multistage inhibitor of HIV-1 capsid function, is active against HIV-2 isolates but 11- to 16-fold less potent against HIV-2 compared to HIV-1 Smith, et al. 2023. In patients with HIV-2 and limited antiretroviral options, treatment with a LEN-based regimen would require careful monitoring to assess virologic and immunologic responsiveness.
In patients with HIV-1/HIV-2 coinfection, HIV-1 drug resistance testing should be performed to guide the choice of an initial regimen or to modify a regimen if virologic failure develops. If HIV-1 drug-resistant virus has been identified, ARV agents that are active only against HIV-1 (such as an NNRTI) can be used to treat individuals with HIV-1/HIV-2 coinfection, as long as a combination of anti-HIV-2 active agents is also used to fully suppress both viruses.
Monitoring ART in Individuals With HIV-2
There is no U.S. Food and Drug Administration-approved, HIV-2 quantitative viral load assay commercially available. However, an HIV-2 quantitative viral load test is available by contacting the Wadsworth Center Bloodborne Viruses Laboratory (see Box 1). In New York State, HIV-2 viral load testing should be used to determine the effectiveness of an antiretroviral therapy (ART) regimen in patients with HIV-2 Ba, et al. 2018; Matheron, et al. 2018. If clinicians outside of New York State do not have access to HIV-2 viral load testing, they should suspect treatment failure if a patient with HIV-2 has a sustained or progressive decline in CD4 count or experiences clinical disease progression on therapy. Data from a multicohort study indicate that patients with HIV-2 who were initiated on a first-line combination ART regimen had less robust CD4 count increases than those with HIV-1, even after adjustment for plasma viral load levels Wittkop, et al. 2017. In HIV-2, a muted CD4 count increase from baseline after treatment initiation may not necessarily imply that the regimen is ineffective.
HIV-2 disease progression has been reported in individuals with undetectable HIV-2 viral loads Raugi, et al. 2021, and resistance mutations have been reported in the presence of suppressive ART (viral load <25 copies/mL) Gottlieb, et al. 2009. Therefore, even with persistent undetected or unquantifiable viral load, CD4 count monitoring is recommended for patients with HIV-2 at least every 6 months.
HIV-2 treatment failure is defined as a persistent increase in viral load. In the absence of HIV-2 viral load testing, treatment failure can be assessed using changes in CD4 count (e.g., a 30% decrease in CD4 count or a 3-point decrease in CD4%, confirmed by repeat testing StatPearls 2023) or clinical disease progression. In cases of treatment failure, it is critically important to address adherence to therapy and to eliminate drug interactions that could adversely affect antiretroviral efficacy, especially given the limited number of ART regimen options. In the absence of HIV-2 genotypic resistance testing, it is reasonable to recommend that a patient with HIV-2 taking a failing integrase strand transfer inhibitor (INSTI)-based regimen switch to an active boosted protease inhibitor (PI)-based regimen. Similarly, it is reasonable to recommend that a patient with HIV-2 on a failing boosted PI-based regimen switch to an INSTI-based regimen. This approach is preferable to switching to other drugs within the INSTI or PI drug class. As noted above, other antiretrovirals, such as maraviroc, ibalizumab, and lenacapavir, have in-vitro activity against HIV-2 and may be included in subsequent treatment regimens. If patients with HIV-2 have either immunologic or virologic treatment failure, clinicians are strongly urged to refer them to or consult with an experienced HIV-2 clinical management specialist.
In addition to monitoring ART, patients with HIV-2 require the same laboratory and diagnostic testing, use and appropriate discontinuation of prophylaxis for opportunistic infections, and use of immunizations as patients with HIV-1.
Management of HIV-2 in Pregnancy
Management of HIV-2 in Pregnancy
Abbreviations: ART, antiretroviral therapy; ATV, atazanavir; DHHS, U.S. Department of Health and Human Services; EFV, efavirenz; NNRTI, non-nucleoside reverse transcriptase inhibitor; RPV, rilpivirine.
A combination of abacavir/lamivudine (3TC) (if HLA-B*5701 is negative) or tenofovir alafenamide/emtricitabine (FTC) or tenofovir disoproxil fumarate (TDF/FTC) or TDF/3TC plus dolutegravir or twice-daily raltegravir or twice daily ritonavir-boosted darunavir is recommended during pregnancy (see Table 3, below). For individuals with HIV-2, viral load monitoring during pregnancy and prophylactic ART for the HIV-2-exposed infant should follow the recommendations for pregnancy and infant exposure to HIV-1 (see the DHHS guideline Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States > Special Populations: HIV-2 Infection and Pregnancy). During the early part of pregnancy, it is important that healthcare providers follow the Wadsworth Center protocol for accurate and timely submission of specimens and know the amount of time needed to return the results of HIV-2 viral load testing. For example, the Wadsworth Center Bloodborne Viruses Laboratory is not open on weekends, so if a patient’s blood is drawn on a Thursday or Friday, the separated plasma should be stored at the drawing facility in a freezer and shipped on Monday, Tuesday, or Wednesday of the following week to ensure weekday delivery to the laboratory.
Serial HIV-2 diagnostic testing in HIV-2-exposed infants to confirm or exclude HIV-2 infection is available free of charge from the Wadsworth Center Bloodborne Viruses Laboratory Services (see Box 1). For diagnostic testing of infants exposed to HIV-2, whole blood collected in an EDTA tube (purple top, prevents blood clotting) must be received in the laboratory within 3 days of collection. Collection kits for pediatric HIV diagnostic testing may be requested from the Wadsworth Center Order Desk at 518-474-4175.
|Table 3: ART Regimens for Initial Treatment of Pregnant Adults With HIV-2 [a]|
|Abacavir/lamivudine (ABC/3TC; Epzicom) if HLA-B*5701 is negative and HBsAg is negative
Tenofovir alafenamide/emtricitabine (TAF/FTC; Descovy)
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC; Truvada)
Tenofovir disoproxil fumarate/lamivudine (TDF/3TC; multiple brands)
|AND||Dolutegravir (DTG; Tivicay) [b,c]
Raltegravir twice daily (RAL; Isentress)
Ritonavir-boosted darunavir twice daily (DRV/r; Prezista and Norvir)
Pre- and Post-Exposure Prophylaxis for HIV-2
PEP for HIV-2
Abbreviations: 3TC, lamivudine; DTG; dolutegravir; FTC, emtricitabine; PEP, post-exposure prophylaxis; RAL, raltegravir; TDF, tenofovir disoproxil fumarate.
As with HIV-1, TDF/FTC, tenofovir alafenamide/FTC, and cabotegravir are active against HIV-2 Smith, et al. 2018; Menendez-Arias and Alvarez 2014 and could be used as a pre-exposure prophylaxis (PrEP) regimen to prevent HIV-2 infection.
|ALL RECOMMENDATIONS: DIAGNOSIS AND MANAGEMENT OF HIV-2 IN ADULTS|
Diagnosis of HIV-2
Treatment of HIV-2
Management of HIV-2 in Pregnancy
PEP for HIV-2
Abbreviations: Ab, antibody; Ag, antigen; ART, antiretroviral therapy; ATV, atazanavir; DHHS, U.S. Department of Health and Human Services; EFV, efavirenz; FDA, U.S. Food and Drug Administration; INSTI, integrase strand transfer inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside/nucleotide reverse transcriptase inhibitor; RPV, rilpivirine.
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].
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|
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. https://www.kingsfund.org.uk/sites/default/files/Making-shared-decision-making-a-reality-paper-Angela-Coulter-Alf-Collins-July-2011_0.pdf
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]
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Updates, Authorship, and Related Guidelines
|Updates, Authorship, and Related Guidelines|
|Date of original publication||July 08, 2019|
|Date of current publication||June 20, 2023|
|Highlights of changes, additions, and updates in the June 20, 2023 edition||
Discussion of several CROI 2023 abstracts was added: see [Johansson, et al. 2023] in the HIV-2 Overview section and [Joly, et al. 2023] and [Smith, et al. 2023] in the Treatment of HIV-2 section.
|Intended users||New York State clinicians who may diagnose and treat adults with HIV-2 infection|
Sanjiv S. Shah, MD, MPH, AAHIVS
Steven M. Fine, MD, PhD; Rona M. Vail, MD; Joseph P. McGowan, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD; 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.
|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.|
|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.|