Interim Guideline on the Use of Twice-Yearly Lenacapavir for HIV Prevention

July 02, 2025

Purpose of This Guideline

Date of current publication: July 2, 2025
Lead authors: Rona M. Vail, MD, AAHIVS; Aviva Cantor, DMSc, PA, AAHIVS
Writing group: 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; Jessica Rodrigues, MPH, MS; Brianna L. Norton, DO, MPH; Charles J. Gonzalez, MD; Christopher J. Hoffmann, MD, MPH, MSc, FACP
Committee: Medical Care Criteria Committee
Date of original publication: July XX, 2025

In June 2025, the U.S. Food and Drug Administration approved lenacapavir (LEN), a long-acting HIV capsid inhibitor given subcutaneously every 6 months (along with an initial 2-day oral loading dose), for use as HIV pre-exposure prophylaxis (PrEP) for sexual exposures in adults and adolescents weighing ≥35 kg FDA 2025.

The full PrEP guideline, PrEP to Prevent HIV and Promote Sexual Health, is undergoing an update. This guideline was developed by the New York State Department of Health AIDS Institute (NYSDOH AI) Clinical Guidelines Program with the goal of providing interim guidance on the use of subcutaneous LEN as PrEP.

Indication

RECOMMENDATIONS
Subcutaneous Lenacapavir as PrEP
  • Clinicians should recommend SC LEN as a preferred PrEP regimen for protection against HIV through sexual exposure for individuals who are willing to receive subcutaneous injections every 6 months and have no contraindications or barriers to its use. (A1) For other preferred PrEP regimens, see the NYSDOH AI guideline PrEP to Prevent HIV and Promote Sexual Health.
  • Clinicians should discuss potential risks and benefits and engage individuals who are or may become pregnant in shared decision-making when considering SC LEN as PrEP. (A3)

Abbreviations: PrEP, pre-exposure prophylaxis; SC LEN, subcutaneous lenacapavir (Yeztugo).

Indication: Because of its statistically superior efficacy to oral PrEP regimens and its protection against HIV through all types of sexual exposure, SC LEN is a preferred PrEP agent for all adults and adolescents weighing ≥35 kg who are open to injectable PrEP. SC LEN joins long-acting injectable cabotegravir (CAB LA; Apretude) as an additional injectable option for individuals who experience adherence challenges with oral PrEP.

Efficacy: Two randomized controlled clinical trials offer strong evidence for the use of SC LEN every 6 months for HIV prevention. In the PURPOSE 1 study of 5,338 cisgender adult and adolescent females aged 16 years and older in South Africa and Uganda, SC LEN was superior to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC; Truvada) and tenofovir alafenamide/emtricitabine (TAF/FTC; Descovy) for HIV prevention, with 100% efficacy Bekker, et al. 2024. The PURPOSE 2 study also found SC LEN to be superior to TDF/FTC for HIV prevention in 3,265 cisgender men and gender-diverse individuals who have sex with partners assigned male sex at birth, with 96% efficacy Kelley, et al. 2025. Superiority was mainly due to decreased adherence to oral PrEP regimens. Both studies found SC LEN to be safe and well tolerated, with the main adverse effect being injection site reactions, which led to discontinuation in 0.2% of participants in the PURPOSE 1 study and 1.2% in the PURPOSE 2 study. There were 2 breakthrough HIV infections in PURPOSE 2, with LEN resistance and high viral loads with the potential for HIV transmission to sex partners. The PURPOSE 3 (among cisgender women in the United States), PURPOSE 4 (among people who inject drugs), and PURPOSE 5 (among individuals not yet on PrEP in the United Kingdom and France) trials are underway.

SC LEN during pregnancy, lactation, and breast/chestfeeding: In the PURPOSE 1 study, there were 208 pregnancies and 132 live births in the SC LEN group Bekker, et al. 2024. There were no pregnancy complications found to be related to SC LEN, and the infant mortality rate was similar to background rates in the study region and to tenofovir-based PrEP. Cesarean rates were similar to non-study births. No adverse effects related to SC LEN during breast/chestfeeding have been observed.

Discuss potential risks and benefits and engage individuals who are or may become pregnant in shared decision-making when considering SC LEN as PrEP. The use of antiretroviral medications during pregnancy is monitored through the Antiretroviral Pregnancy Registry.

Dosing, Administration, and Other Considerations

RECOMMENDATION
Dosing, Preparation, and Administration of SC LEN as PrEP

Abbreviations: PrEP, pre-exposure prophylaxis; SC LEN, subcutaneous lenacapavir (Yeztugo).

Dosing: SC LEN is administered as an initial 927 mg injection accompanied by an oral loading dose of LEN 600 mg tablets daily on days 1 and 2, followed by maintenance injections of 927 mg every 6 months. See Box 1, below, for additional details on dosing, preparation, and administration of SC LEN as PrEP.

Box 1: Dosing, Preparation, and Administration of Subcutaneous Lenacapavir as Pre-Exposure Prophylaxis [a]
How supplied:
  • Injection: 463.5 mg/1.5 mL (309 mg/mL) in 2 single-dose vials, 2 vial access devices, 2 disposable syringes, and 2 injection safety needles for subcutaneous (SC) injection (22 gauge, ½ inch)
  • Tablets: 300 mg
  • Oral lenacapavir (LEN) tablets should be stored at room temperature, between 68° and 77° F, in their original packaging.
  • SC LEN vials should be stored at room temperature, between 68° and 77° F, with excursions permitted at 59° to 86° F. Vials should be kept in their original carton until just before use to protect from light. Do not shake the vial before injection.
Initiation dose:
  • Day 1: 927 mg (3 mL) LEN by SC injection (two 1.5 mL injections in separate areas) plus 600 mg LEN orally (two 300 mg tablets)
  • Day 2: 600 mg LEN orally (two 300 mg tablets)
Maintenance dose:
  • Every 6 months (26 weeks), plus or minus 2 weeks, from the date of the last injection: 927 mg (3 mL) LEN by SC injection (two 1.5 mL injections in separate areas)
Preparation and administration:
  • Use of ice packs before and after, and analgesics after injections significantly decreases discomfort from injection site reactions (ISRs).
  • Once the solution has been drawn into the syringes, administer as soon as possible. Discard solution if not used within 4 hours.
  • SC LEN injections are administered at a 90° angle to decrease the risk of ISRs. The preferred site of administration is the abdomen, placing the 2 injections on opposite sides. One injection into each lateral thigh can be used as an alternative injection site if preferred.
  • SC LEN is not appropriate for self-injection and should be administered by a healthcare professional.

Note:

  1. FDA 2025

Adverse effects: The most common and expected adverse effects associated with SC LEN are injection site reactions (ISRs), which may include pain, erythema, swelling, nodules, induration, and pruritus. Individuals receiving SC LEN as PrEP should be counseled to expect potential discomfort, induration, and subcutaneous nodules in the first week after the injection. SC LEN injections commonly create persistent subcutaneous nodules, which in the PURPOSE-2 study lasted a median of 183 days Kelley, et al. 2025. Although they are generally painless, the nodules can be palpated and sometimes visible depending on the physique of the individual. ISRs rarely led to discontinuation in the studies discussed above. Proper injection technique (using ice packs at the site before injection and injecting at a 90° angle) can significantly decrease the incidence and intensity of ISRs FDA 2025Kelley, et al. 2025.

Drug-drug interactions: Because lenacapavir is a substrate and moderate inhibitor of cytochrome P450 (CYP)3A4 and a substrate of P-glycoprotein (P-gp), the potential for drug-drug interactions associated with the use of SC LEN as PrEP should be carefully considered. Although the risk of drug-drug interactions when combining LEN with most medications used in primary care is low, there is a risk of reduced LEN drug concentrations when used concurrently with CYP3A4 or P-gp inducers. Examples of common CYP3A4 inducers can be remembered with the mnemonic COPPER: Carbamazepine, Oxcarbazepine, Phenobarbital (and primidone), Phenytoin, Enzalutamide, and Rifampin (also rifabutin and rifapentine). Although not a complete list, these are the most common CYP3A4 inducers used in clinical practice.

The current U.S. Food and Drug Administration (FDA) prescribing information for SC LEN for HIV prevention provides recommendations for supplemental dosing with LEN injections and/or oral tablets to offset potential interactions; these recommendations vary depending on whether a strong or a moderate CYP3A4 inducer is being added to LEN. For guidance in determining the degree of induction from CYP3A4 (and other isoenzymes of CYP450) when managing drug-drug interactions, consult the following resources:

Note that FDA recommendations for managing concurrent use of CYP3A4 inducers differ greatly in the prescribing information for LEN used as HIV prevention (Yeztugo) and LEN used for HIV treatment (Sunlenca).

Time to protection: Data on time to protection of SC LEN are limited, but rapid increases have been observed in plasma concentrations of LEN after the initial oral loading dose and first injection, reaching therapeutic levels within hours after the second oral loading dose on day 2 Gilead 2025Jogiraju, et al. 2025. Individuals initiating SC LEN who are not already taking PrEP should be counseled on using additional HIV prevention techniques, including barrier protection and abstinence, during the oral loading period. Individuals switching from oral PrEP to SC LEN are protected from HIV on the day of the initial injection. If the second oral loading dose is missed, the time to protection increases to 21 days Gilead 2025.

Hepatitis B virus (HBV) prevention and treatment: SC LEN does not prevent or treat HBV infection. When considering or switching to SC LEN as PrEP, perform HBV testing if an individual’s hepatitis serologies are unknown or if there was borderline or low-level immunity in the past. Unrecognized chronic HBV can flare when tenofovir-containing regimens are discontinued. Individuals with chronic HBV who are switching from an oral PrEP regimen will need to continue oral tenofovir or other HBV treatment options while using SC LEN. Non–HBV-immune individuals should be offered routine vaccination to prevent HBV infection. See the NYSDOH AI guideline Prevention and Management of Hepatitis B Virus Infection in Adults With HIV.

KEY POINTS
  • Apply ice packs to the planned injection sites for 10 minutes before injection and use analgesics as needed to decrease discomfort from ISRs.
  • Administer SC LEN injections at a 90° angle to decrease the risk of ISRs.
  • The day 2 dose of oral LEN is necessary to assure adequate LEN levels during initiation.
  • Supplemental doses of SC LEN are recommended for individuals initiating either strong or moderate CYP3A inducers.

Initiation and Continuation of SC LEN PrEP

Initiation visit: 

Assessment:

  • Assess for signs and symptoms of acute HIV infection.
  • Review prescribed medications and inquire about any over-the-counter medications or supplements for potential drug-drug interactions with lenacapavir (LEN).
  • Assess need for additional support for behavioral health, primary care, reproductive health, substance use, housing, or other medical and social services.

Laboratory testing:

  • Laboratory-based HIV antigen (Ag)/antibody (Ab) test within 7 days of initiation or a rapid HIV Ag/Ab test on the day of initiation pending laboratory-based HIV Ag/Ab confirmation
  • HIV RNA polymerase chain reaction (PCR) assay to rule out acute HIV infection in individuals not already taking and adherent to pre-exposure prophylaxis (PrEP)
  • Sexually transmitted infection (STI) testing as per routine PrEP protocols (see NYSDOH AI guideline PrEP to Prevent HIV and Promote Sexual Health > Ongoing Laboratory Testing > STI screening)
  • Hepatitis B surface antigen and antibody (HBsAg and anti-HBs) and core antibody (anti-HBc) testing to rule out active hepatitis B virus (HBV) infection and assess need for HBV vaccination if an individual’s hepatitis serologies are unknown or if there was borderline or low-level immunity in the past

Education:

  • Discuss the importance of adherence to the oral loading dose of LEN and provide the dosing pack for self-administration on the following day (day 2).
  • Discuss potential adverse effects and ways to mitigate discomfort associated with injection site reactions (ISRs), such as using ice and over-the-counter analgesics.
  • Ensure individuals know how to contact the care team with questions or concerns.
  • Review the timeframe for subsequent injections, and the importance of communication with the care team if an appointment will be rescheduled or missed.
  • Review the availability of oral bridging medication should an injection need to be delayed beyond 28 weeks (6 months plus 2 weeks).

Follow-up:

  • Schedule the follow-up injection visit for 6 months (plus or minus 2 weeks) from the current visit.
  • Consider an interim 3-month HIV testing and STI screening visit based on risk (can defer HIV/STI screening if the individual is low risk) or plan for interim STI testing at an external laboratory; if appropriate, discuss doxycycline post-exposure prophylaxis (doxy-PEP) for bacterial STI prevention (see NYSDOH AI guideline Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections).
Continuation visit:
  • Assess for signs and symptoms of acute HIV infection since the last visit.
  • Confirm continued interest in PrEP and review PrEP options.
  • Assess for ISRs since last visit and review management options.
  • Review prescribed and over-the-counter medications to assess for drug-drug interactions.
  • Confirm a negative laboratory-based HIV Ag/Ab test result within the past 7 days or a rapid Ag/Ab test with a laboratory-based HIV Ag/Ab test on day of visit. A nucleic acid amplification test (HIV viral load test) is not required for on-time dosing.
  • Perform STI screening as per PrEP protocols and discuss doxy-PEP as appropriate (see links above).
  • Schedule the follow-up injection visit for 6 months (plus or minus 2 weeks).
  • Stress the importance of communication with the individual’s care team for any changes to scheduled visits or insurance.
  • Review the availability of oral bridging medication should an injection need to be delayed beyond 28 weeks (6 months plus 2 weeks).
  • Assess need for additional support for behavioral health, primary care, reproductive health, substance use, housing, or other medical and social services.

Managing missed injections: As mentioned above, subcutaneous (SC) LEN is given every 6 months, with a window period of 2 weeks before or after the prior injection. Missed injections are bridged with oral LEN or another oral PrEP regimen if oral LEN is not available. For both planned and unplanned missed injections, if oral LEN is not initiated for bridging and more than 28 weeks have lapsed since the prior injection, reinitiation with oral LEN 600 mg daily for 2 days is needed in addition to LEN injections.

  • Planned missed injection >14 days late (>28 weeks since the last injection): If an individual misses their LEN injection for a planned reason, initiate oral LEN 300 mg once every 7 days (beginning when the injection is due) and continue until SC LEN can be administered, up to a maximum of 6 months (26 weeks). If the injection is missed beyond 6 months (i.e., more than 52 weeks since the last injection), transition the individual to another PrEP regimen if they plan to continue PrEP (see Discontinuing SC LEN, below). If oral LEN is not available for bridging, prescribe another oral PrEP regimen.
  • Unplanned missed injection >14 days late (>28 weeks since the last injection): If an individual misses their SC LEN injection for an unplanned reason, determine why the individual is unable to return and refer them for appropriate services as needed. Offer the individual oral LEN or another oral PrEP regimen as noted above for planned missed injections.

Discontinuing SC LEN: Levels of SC LEN begin to decline in the body 6 months after the last injection and continue to decline over 18 months (the medication “tail”). During this time there are increasingly lower levels of SC LEN that will not protect from HIV infection. Individuals receiving SC LEN as PrEP should be educated on the medication “tail” and provided individualized guidance on alternative PrEP options and prevention planning if HIV risk continues.

Managing a positive HIV test result: See Managing a Positive HIV Test Result in the NYSDOH AI PrEP to Prevent HIV and Promote Sexual Health guideline. For individuals who have a positive HIV test result while receiving SC LEN for PrEP, a first-line integrase-based antiretroviral regimen should be initiated while awaiting confirmatory test results; see the NYSDOH AI guideline Selecting an Initial ART Regimen.

Implementation of SC LEN PrEP in Clinical Settings

The logistics of subcutaneous lenacapavir in pre-exposure prophylaxis programs may be challenging and require institutional, clinician, and individual preparations. Procedures for obtaining prior authorizations, medication storage, scheduling and reminders, tracking systems, staff education, and staffing levels must be addressed with implementation plans appropriate to each setting (see Box 2, below).

Box 2: Implementation Strategies for Subcutaneous Lenacapavir as Pre-Exposure Prophylaxis
Institutional and clinician preparations:
  • Assess pharmacy resources and on-site procedures for storage of oral and injectable medications.
  • Develop procedures for obtaining prior authorizations for insurance and third-party coverage.
  • Train medical care providers on the protocols for lenacapavir (LEN) use and monitoring.
  • Train nurses and other medical care providers regarding proper syringe preparation and injection techniques.
  • Establish billing protocols for the procurement and administration of injectable pre-exposure prophylaxis (PrEP).
  • Implement an appointment-reminder system and make call-backs after missed doses.
  • Plan for treatment continuation during shutdowns or other catastrophic events.
  • Educate about the use of oral bridging therapy when appropriate.
  • Educate about possible adverse effects of LEN and how to manage them.
  • Ensure that individuals know how to reach the care team if needed.
  • Schedule follow-up appointments for administration in advance.
PrEP recipient preparations:
  • Confirm the ability to maintain required clinic visit schedule for injections, including transportation availability.
  • Advise on the importance of communicating with the team regarding any insurance and coverage changes.

Comparison of Available PrEP Regimens

Table 1, below, compares the benefits, limitations, and risks of available regimens for HIV pre-exposure prophylaxis. For additional information, see the NYSDOH AI guideline PrEP to Prevent HIV and Promote Sexual Health.

Abbreviations: CAB LA, long-acting injectable cabotegravir (Apretude); HBV, hepatitis B virus; HSV, herpes simplex virus; IM, intramuscular; MSM, men who have sex with men; PrEP, pre-exposure prophylaxis; SC LEN, subcutaneous lenacapavir (Yeztugo); STI, sexually transmitted infection; TAF/FTC, tenofovir alafenamide/emtricitabine (Descovy); TDF/FTC, tenofovir disoproxil fumarate/emtricitabine (Truvada).

Note:

  1. Some protection against HSV has been reported in heterosexual populations without HIV Celum, et al. 2014.
Table 1: Benefits, Limitations, and Risks of Available PrEP Regimens
All PrEP Regimens Oral PrEP With TDF/FTC or TAF/FTC Injectable PrEP With CAB LA Injectable PrEP With SC LEN
Benefits
  • Highly effective when taken as directed
  • May decrease anxiety regarding HIV acquisition
  • Engages sexually active at-risk individuals in care who are then screened regularly for STIs
  • 99% effective in reducing the risk of HIV acquisition when used as prescribed
  • TDF/FTC: Indicated for all sexual and injection exposures
  • TAF/FTC: Indicated for sexual exposures in MSM and in transgender women who have sex with men
  • Single tablet taken daily, or for TDF/FTC can also be taken before and after sex
  • Good safety profiles in people who do not have HIV
  • Minimal adverse effects, most of which resolve quickly or can be managed
  • TDF/FTC appears to be safe for use during attempts to conceive and during pregnancy
  • Treats HBV infection
  • Statistical superiority to TDF/FTC has been attributed to a lack of adherence to the oral regimen
  • Indicated for all sexual exposures
  • Administered intramuscularly once every 2 months
  • Directly observed therapy
  • Advantageous option when adherence to oral PrEP may be challenged by ongoing substance use or mental health concerns, neurocognitive disorders, difficulty swallowing pills, privacy concerns, or other challenges
  • Statistical superiority to TDF/FTC has been attributed to a lack of adherence to the oral regimen
  • Indicated for all sexual exposures
  • Administered subcutaneously once every 6 months
  • Directly observed therapy
  • Advantageous option when adherence to oral PrEP may be challenged by ongoing substance use or mental health concerns, neurocognitive disorders, difficulty swallowing pills, privacy concerns, or other challenges
Limitations
  • Protection correlates with adherence to the dosing schedule
  • No significant protection against STIs other than HIV [a]
  • Requires adherence to the daily administration schedule
  • Requires planning and adherence when TDF/FTC is dosed on demand
  • No data on TAF/FTC for individuals who inject drugs
  • Requires additional monitoring in individuals with chronic HBV infection
  • Cost of TAF/FTC (no generic available)
  • Requires deep IM injection
  • No data for individuals who inject drugs
  • Requires oral medications as bridging therapy when injections are missed
  • Requires ≥6 in-person healthcare visits per year
  • Does not treat HBV infection
  • Not appropriate for individuals with injectable silicone or other fillers in the gluteal area
  • Implementation logistics
  • Cost (no generic available)
  • Increased risk of long-term impactful medication interactions
  • Data pending for individuals who inject drugs
  • Requires oral medications as bridging therapy when injections are missed
  • Does not treat HBV infection
  • Implementation logistics
  • Cost (no generic available)
Risks
  • Potential for delayed detection of HIV infection using standard HIV testing algorithms
  • Continued use after undiagnosed HIV infection may result in development of drug-resistant virus
  • Safety concerns for individuals with impaired kidney function
  • Compared with TAF, TDF may be associated with reversible decreases in bone density
  • Potential injection site reactions and other adverse events, including pyrexia
  • Long tail phase once treatment is discontinued
  • Potential for breakthrough infections despite on-time injections
  • Injection site reactions are common (nodules, pain, and erythema at injection site)
  • Long tail phase once treatment is discontinued
  • Potential for breakthrough infections despite on-time injections

All Recommendations

ALL RECOMMENDATIONS: INTERIM GUIDELINE ON THE USE OF TWICE-YEARLY LENACAPAVIR FOR HIV PREVENTION
Subcutaneous Lenacapavir as PrEP
  • Clinicians should recommend SC LEN as a preferred PrEP regimen for protection against HIV through sexual exposure for individuals who are willing to receive subcutaneous injections every 6 months and have no contraindications or barriers to its use. (A1) For other preferred PrEP regimens, see the NYSDOH AI guideline PrEP to Prevent HIV and Promote Sexual Health.
  • Clinicians should discuss potential risks and benefits and engage individuals who are or may become pregnant in shared decision-making when considering SC LEN as PrEP. (A3)
Dosing, Preparation, and Administration of SC LEN as PrEP

Abbreviations: PrEP, pre-exposure prophylaxis; SC LEN, subcutaneous lenacapavir (Yeztugo).

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]

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]

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Updates, Authorship, and Related Guidelines

Updates, Authorship, and Related Guidelines
Date of original publication July 02, 2025
Intended users Clinicians who are recommending, initiating, or maintaining pre-exposure prophylaxis (PrEP) care for individuals at risk of acquiring HIV
Lead author(s)

Rona M. Vail, MD, AAHIVS; Aviva Cantor, DMSc, PA, AAHIVS1

1Callen-Lorde Community Health Center, New York, NY

Writing group

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; Jessica Rodrigues, MPH, MS; Brianna L. Norton, DO, MPH; Charles J. Gonzalez, MD; Christopher J. Hoffmann, MD, MPH, MSc, FACP

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
Guidelines
Podcast

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 July 9, 2025