Causal Effects of Stochastic PrEP Interventions on HIV Incidence Among Men Who Have Sex With Men.

Antiretroviral preexposure prophylaxis (PrEP) is highly effective in preventing human immunodeficiency virus (HIV) infection, but uptake has been limited and inequitable. Although interventions to increase PrEP uptake are being evaluated in clinical trials among men who have sex with men (MSM), those trials cannot evaluate effects on HIV incidence. Estimates from observational studies of the causal effects of PrEP-uptake interventions on HIV incidence can inform decisions about intervention scale-up. We used longitudinal electronic health record data from HIV-negative MSM accessing care at Fenway Health, a community health center in Boston, Massachusetts, from January 2012 through February 2018, with 2 years of follow-up. We considered stochastic interventions that increased the chance of initiating PrEP in several high-priority subgroups. We estimated the effects of these interventions on population-level HIV incidence using a novel inverse-probability weighted estimator of the generalized g-formula, adjusting for baseline and time-varying confounders. Our results suggest that even modest increases in PrEP initiation in high-priority subgroups of MSM could meaningfully reduce HIV incidence in the overall population of MSM. Interventions tailored to Black and Latino MSM should be prioritized to maximize equity and impact.

Potential impact of doxycycline post-exposure prophylaxis prescribing strategies on incidence of bacterial sexually transmitted infections.

BACKGROUND: Doxycycline post-exposure prophylaxis (doxyPEP) reduces bacterial sexually transmitted infection (STI) incidence in people with HIV (PWH) or using HIV preexposure prophylaxis (PrEP). Given concerns about widespread antibiotic use, we identified doxyPEP prescribing strategies to minimize use while maximizing impact on STIs. METHODS: We used electronic health records of gay and bisexual men (GBM), transgender women, and non-binary people assigned male sex at birth with ≥2 STI tests (chlamydia, gonorrhea, syphilis) at an LGBTQ-focused health center during 2015-2020. We defined 10 hypothetical doxyPEP prescribing strategies based on PrEP use, HIV status, or STI history. We estimated doxyPEP use and STI diagnoses averted in counterfactual scenarios in which people meeting prescribing criteria received doxyPEP, assuming STI rates during use would have been reduced by clinical trial efficacy estimates. RESULTS: Among 10,546 individuals (94% GBM), rate of any STI was 35.9/100 person-years. Prescribing doxyPEP to all individuals would have averted 71% of STI diagnoses (number needed to treat for one year to avert one STI diagnosis, NNT = 3.9); prescribing to PrEP users/PWH (52%/12% of individuals) would have averted 60% of STI diagnoses (NNT = 2.9). Prescribing doxyPEP for 12 months after STI diagnosis would have reduced the proportion using doxyPEP to 38% and averted 39% of STI diagnoses (NNT = 2.4). Prescribing after concurrent or repeated STIs would have maximized efficiency (lowest NNTs) but prevented fewer STIs. CONCLUSIONS: Prescribing doxyPEP to individuals with STIs, particularly concurrent or repeated STIs, could avert a substantial proportion of all STI diagnoses. The most efficient prescribing strategies are based on STI history rather than HIV status or PrEP use.

Provider Implicit Bias in Prescribing HIV Pre-exposure Prophylaxis (PrEP) to People Who Inject Drugs.

BACKGROUND: Multiple HIV outbreaks among people who inject drugs (PWIDs) have occurred in the USA since 2015, highlighting the need for additional HIV prevention tools. Despite high levels of need, pre-exposure prophylaxis (PrEP) is drastically underutilized among PWIDs. Implicit bias toward PWID held by clinicians may impede PrEP scale-up among these underserved patients. This study examined how primary care providers' (PCPs) clinical decisions related to PrEP can be impacted by biases when the patient has a history of substance use. METHODS: We conducted an online survey of PCPs (n = 208). The survey included the implicit association test (IAT) to assess unconscious attitudes toward PWIDs, direct questions regarding clinicians' explicit PWID attitudes, and an embedded experiment in which we systematically varied the risk behavior of a hypothetical patient and asked PCPs to make clinical judgments. RESULTS: A minority (32%) of PCPs reported explicit PWID bias. The IAT indicated strong implicit PWID bias (meant IAT score = 0.59, p < .0001) among 88% of the sample. Only 9% of PCPs had no implicit or explicit PWID bias. PWID patients were judged as less likely to adhere to a PrEP regimen, less responsible, and less HIV safety conscious than heterosexual or gay male patients. Anticipated lack of adherence mediated PCPs' intent to prescribe PrEP to PWID. CONCLUSIONS: PCPs' bias may contribute to PrEP being under-prescribed to PWID. Implicit and explicit PWID biases were common in our sample. This study illustrates the need to develop and test tailored interventions to decrease biases against PWID in primary care settings.

Acceptability and Effectiveness of a One-Hour Healthcare Provider Intervention Integrating HIV Pre-Exposure Prophylaxis and Cultural Competence Training.

Enhanced provider training could improve PrEP access and equity. We conducted a pilot randomized controlled trial comparing (a) a one-hour, group-based provider intervention integrating PrEP and Cultural Competence (PCC) training with (b) a standard HIV continuing medical education session (n = 56). PCC participants favorably rated the intervention and reported increased PrEP knowledge. The PCC intervention increased their confidence performing PrEP-related clinical activities and intention to prescribe PrEP. The percentage of participants discussing PrEP with patients increased marginally in both study conditions. The percentage of participants who prescribed PrEP and self-rated cultural competence did not change in either study condition.

RESUMEN: Una mejor capacitación de los proveedores podría mejorar el acceso y la equidad de la PrEP. Realizamos un ensayo controlado aleatorizado piloto que comparó (a) una intervención grupal de proveedores de una hora que integraba la capacitación en PrEP y competencia cultural (PCC) con (b) una sesión estándar de educación médica continua sobre el VIH (n = 56). Los participantes de PCC calificaron favorablemente la intervención e informaron un mayor conocimiento de la PrEP. La intervención de PCC aumentó su confianza en la realización de actividades clínicas relacionadas con la PrEP y su intención de prescribir la PrEP. El porcentaje de participantes que discutieron la PrEP con los pacientes aumentó marginalmente en ambas condiciones del estudio. El porcentaje de participantes que prescribieron la PrEP y la competencia cultural autoevaluada no cambió en ninguna de las condiciones del estudio.

A qualitative exploration of how to support PrEP adherence among young men who have sex with men.

New HIV infections disproportionately affect young men who have sex with men (YMSM). PrEP is effective in preventing HIV acquisition; however, adherence is critical and is often suboptimal among YMSM. Interventions addressing the unique PrEP adherence challenges faced by YMSM are needed. We conducted qualitative interviews with 20 HIV-negative, YMSM (ages 15-24) with a PrEP indication and 11 healthcare professionals to inform adaption of a PrEP adherence intervention (Life-Steps for PrEP) for YMSM. We explored environmental, healthcare, and individual factors influencing uptake, adherence, attitudes, and perspectives (including desired modifications) on the Life-Steps intervention. Interviews were analyzed using content analysis. Of YMSM study participants (mean age 21.6) 55% were White, 15% Hispanic, and 5% Black. Most YMSM were PrEP-experienced (70%). Healthcare professionals (6 prescribers, 1 nurse, 2 health educators, 2 other/unspecified) averaged 6.9 years of experience caring for YMSM. All described stigma as a barrier to PrEP; YMSM expressed concern around being perceived as "risky" and concern about inadvertent PrEP disclosure if family/friends found their medication, or if parental insurance was used. Difficulty with planning for potential adherence challenges were identified by both groups. YMSM highlighted benefits of a nurse-led intervention (i.e., adding "legitimacy"), but stressed need for nonjudgmental, "savvy" interventionists. YMSM expressed a desire for comprehensive YMSM-specific sexual health information. These findings informed modification and expansion of Life-Steps content. Results highlight key potential barriers, many of which center around privacy. Content that addresses PrEP stigma, disclosing PrEP use, navigating insurance, and planning ahead in a nonjudgmental environment by trusted providers emerged as important components of a YMSM-focused delivery of Life-Steps for PrEP.

Perspectives of Young Men Who Have Sex with Men on PrEP Adherence and Peer Navigation: A Qualitative Study.

HIV incidence is disproportionately high among young cisgender men who have sex with men (YMSM), but YMSM are less likely than adults to use HIV pre-exposure prophylaxis (PrEP). Among YMSM living with HIV, peer navigation programs have been effective in linkage to care and increasing medication adherence; such programs may aid HIV-uninfected YMSM in overcoming barriers to engagement in PrEP care. We conducted 32 semi-structured qualitative interviews at a community health center in Massachusetts, USA, specializing in sexual and gender minority health with four sub-groups of YMSM who: (1) had never discussed PrEP with a medical provider, (2) had discussed PrEP with a medical provider but declined a prescription, (3) were prescribed PrEP and have sub-optimal adherence (taking fewer than 4 pills per week), and (4) were prescribed PrEP and were optimally adherent. Domains addressed in the interviews included knowledge of PrEP and HIV prevention, barriers and facilitators to PrEP adherence, and attitudes toward peer navigation for PrEP. Interviews were transcribed and coded using thematic analysis methodology. Multiple themes emerged from the interviews, including finding that perceived costs, anticipated stigma, sexual activity, and relationship status influence PrEP uptake and adherence; establishing pill-taking routines is an important adherence facilitator; and peer navigators could offer benefits for PrEP adherence.

Study protocol for an efficacy trial of the "PrEP for Health" intervention to increase HIV PrEP use among people who inject drugs.

BACKGROUND: HIV incidence has recently increased among people who inject drugs (PWID) across the United States, with outbreaks occurring in states with long-standing syringe service programs (SSPs) including Massachusetts (MA). Antiretroviral pre-exposure prophylaxis (PrEP) is an evidence-based HIV prevention strategy recommended for PWID, but uptake in this marginalized population is extraordinarily low. METHODS: We describe the design and procedures for a National Institute on Drug Abuse (NIDA)-funded (R01) randomized controlled trial (RCT) testing the efficacy of "PrEP for Health," a multicomponent behavioral intervention to increase PrEP uptake, adherence, and persistence among HIV-negative PWID attending SSPs in two areas of the U.S. Northeast that are heavily affected by injection-related HIV transmission. Participants are equally randomized to receive the "PrEP for Health" intervention (involving individually tailored HIV and PrEP education, motivational interviewing, problem-solving skills and planning, and ongoing navigation support) or an enhanced standard of care (eSOC) control condition involving a brief educational video on the utility of PrEP for HIV prevention. Co-primary outcomes are PrEP uptake (using medical/pharmacy records) and adherence (using tenofovir quantification in hair samples); a secondary outcome is PrEP persistence (using medical/pharmacy records) over 12 months. Major assessments occur at baseline, 1-, 3-, 6-, and 12-month follow-up visits. Planned analyses will examine intervention efficacy, specific hypothesized conceptual mediators of the intervention effect (e.g., self-perceived HIV risk; PrEP knowledge, interest in use, motivation, and behavioral skills) and epidemiologically linked moderators (e.g., age; gender; condomless vaginal or anal sex). DISCUSSION: Findings from our extensive preliminary research with the study population revealed that a multicomponent, theory-based intervention targeting PrEP knowledge, motivation, self-efficacy, behavioral skills, and structural barriers to PrEP access is urgently needed for PWID who are at risk of HIV acquisition. We also learned that SSPs represent a highly acceptable service setting for delivering such interventions. In this study, we are evaluating the efficacy of the "PrEP for Health" intervention. If efficacious, findings from our implementation evaluation could help guide its dissemination to diverse SSPs and possibly other community-based settings accessed by this population. TRIAL REGISTRATION: ClinicalTrials.gov number NCT04430257, registered June 12, 2020.

Optimizing Provider Preexposure Prophylaxis (PrEP) Training: A Cross-Sectional Analysis of Recommendations from Providers Across the PrEP Implementation Cascade.

Expanding PrEP access necessitates training that supports healthcare providers' progression along the PrEP implementation cascade, moving from PrEP awareness to prescription. We surveyed 359 USA providers about PrEP training content and format recommendations. We examined the association between cascade location and training recommendations. Most providers were aware of PrEP (100%), willing to prescribe PrEP (97.2%), had discussed PrEP with patients (92.2%), and had prescribed PrEP (79.9%). Latent class regression analysis revealed that cascade location was associated with training recommendations. Although all providers recommended PrEP-specific content (e.g., patient eligibility), providers who were located further along the cascade also recommended more comprehensive content, including sexual history-taking and sexual and gender minority competence training. Providers further along the cascade were also more likely to recommend interactive training formats (e.g., role-playing). These insights from providers furthest along the cascade indicate the importance of including comprehensive content and interactive formats in future PrEP training initiatives.

An Experimental Study of the Effects of Patient Race, Sexual Orientation, and Injection Drug Use on Providers' PrEP-Related Clinical Judgments.

Social biases may influence providers' judgments related to pre-exposure prophylaxis (PrEP) and patients' consequent PrEP access. US primary and HIV care providers (n = 370) completed an experimental survey. Each provider reviewed one fictitious medical record of a patient seeking PrEP. Records varied by patient race (Black or White) and risk behavior (man who has sex with men [MSM], has sex with women [MSW], or injects drugs [MID]). Providers reported clinical judgments and completed measures of prejudice. Minimal evidence of racially biased judgments emerged. Providers expressing low-to-moderate sexual prejudice judged the MSM as more likely than the MSW to adhere to PrEP, which was associated with greater PrEP prescribing intention; sexual prejudice was negatively associated with anticipated MSM adherence. Providers judged the MID to be at higher risk, less likely to adhere, less safety-conscious, and less responsible than both the MSM and MSW; adverse adherence and responsibility judgments were associated with lower prescribing intention.

RESUMEN: Los sesgos sociales pueden influir sobre los juicios de proveedores de salud con respecto a la profilaxis pre-exposición (PrEP) y el consecuente acceso de los pacientes a PrEP. Proveedores de cuidados primarios y de VIH en los Estados Unidos (n = 370) respondieron una encuesta experimental. Cada proveedor leyó una historia médica de un paciente ficticio interesado en obtener PrEP. Las historias médicas variaron la raza (Negro o Blanco) y conducta de riesgo (hombre que tiene sexo con hombres [HSH], hombre que tiene sexo con mujeres [HSM], u hombre  usuario de drogas inyectables [HDI]) del paciente. Los proveedores reportaron juicios clínicos y completaron medidas sobre prejuicio. La evidencia sobre sesgos raciales en los juicios clínicos fue mínima. Los proveedores que expresaron prejuicio sexual bajo a moderado, juzgaron que el paciente HSH tendría mayor adherencia a PrEP que el paciente HSM, lo cual se asoció con mayor intención de prescribir PrEP; el prejuicio sexual se asoció negativamente con la adherencia anticipada en HSH. El paciente HDI fue percibido como en mayor riesgo, con menor adherencia, menos preocupado por la seguridad, y menos responsable que los HSH y HSM; los juicios sobre baja adherencia y responsabilidad estuvieron asociados con menor intención de prescribir PrEP.

"Let's Be a Person to Person and Have a Genuine Conversation": Comparing Perspectives on PrEP and Sexual Health Communication Between Black Sexual Minority Men and Healthcare Providers.

Patient-provider communication is a key factor affecting HIV pre-exposure prophylaxis (PrEP) awareness and access among Black sexual minority men (SMM). Optimizing patient-provider communication requires a deeper understanding of communication dynamics. In this study, we investigated the perspectives of both HIV-negative/status-unknown Black SMM and practicing community healthcare providers regarding patient-provider communication about PrEP and sexual health. We conducted eleven semi-structured qualitative focus groups (six with Black SMM; five with providers) in the Northeastern USA and thematically analyzed transcripts. A total of 36 Black SMM and 27 providers participated in the focus groups. Our analysis revealed points of alignment and divergence in the two groups' perspectives related to patient-provider communication. Points of alignment included: (1) the importance ascribed to maximizing patients' comfort and (2) belief in patients' right to non-discriminatory healthcare. Points of divergence included: (1) Black SMM's preference for sexual privacy versus providers' preference that patients share sexual information, (2) Black SMM's perception that providers have an ethical responsibility to initiate conversations about PrEP with patients versus providers' perception of such conversations as being optional, and (3) Black SMM's preference for personalized sexual health conversations versus providers' preference for standardized conversations. Findings underscore a need for providers to offer more patient-centered sexual healthcare to Black SMM, which should entail routinely presenting all prevention options available-including PrEP-and inviting open dialogue about sex, while also respecting patients' preferences for privacy about their sexuality. This approach could increase PrEP access and improve equity in the US healthcare system.

HIV Preexposure Prophylaxis and Sexual Satisfaction Among Men Who Have Sex With Men.

ABSTRACT: In this large online survey of primarily men who have sex with men, those who used preexposure prophylaxis reported greater sexual satisfaction than did nonusers, including sexual sensations, sexual presence/awareness, and sexual exchange. Person-centered care and messaging may require acknowledging that some people use preexposure prophylaxis for reasons beyond HIV prevention.

Patient-Led Decision-Making for HIV Preexposure Prophylaxis.

PURPOSE OF REVIEW: Shared decision-making is a process that involves bidirectional exchange of information between patients and providers to support patients in making individualized, evidence-based decisions about their healthcare. We review the evidence on patient-led decision-making, a form of shared decision-making that maximizes patient autonomy, as a framework for decisions about HIV preexposure prophylaxis (PrEP). We also assess the likelihood that patient-led decision-making occurs for PrEP and describe interventions to facilitate this process. RECENT FINDINGS: Patient-led decision-making is likely to be uncommon for PrEP, in part because healthcare providers lack knowledge and training about PrEP. Few evidence-based interventions exist to facilitate patient-led decision-making for PrEP. There is a need for rigorously developed interventions to increase knowledge of PrEP among patients and healthcare providers and support patient-led decision-making for PrEP, which will be increasingly important as the range of available PrEP modalities expands.

Primary Care Providers' Perspectives on Using Automated HIV Risk Prediction Models to Identify Potential Candidates for Pre-exposure Prophylaxis.

Identifying patients at increased risk for HIV acquisition can be challenging. Primary care providers (PCPs) may benefit from tools that help them identify appropriate candidates for HIV pre-exposure prophylaxis (PrEP). We and others have previously developed and validated HIV risk prediction models to identify PrEP candidates using electronic health records data. In the current study, we convened focus groups with PCPs to elicit their perspectives on using prediction models to identify PrEP candidates in clinical practice. PCPs were receptive to using prediction models to identify PrEP candidates. PCPs believed that models could facilitate patient-provider communication about HIV risk, destigmatize and standardize HIV risk assessments, help patients accurately perceive their risk, and identify PrEP candidates who might otherwise be missed. However, PCPs had concerns about patients' reactions to having their medical records searched, harms from potential breaches in confidentiality, and the accuracy of model predictions. Interest in clinical decision-support for PrEP was greatest among PrEP-inexperienced providers. Successful implementation of prediction models will require tailoring them to providers' preferences and addressing concerns about their use.

Low Awareness of and Access to Pre-exposure Prophylaxis But High Interest Among Heterosexual Women in Cleveland, Ohio.

Women received <5% of all US pre-exposure prophylaxis (PrEP) prescriptions in 2016. Among 351 heterosexual women surveyed in Cleveland, Ohio, 14.5% were aware of PrEP, 20.5% knew where to access PrEP, 75.9% were willing to try PrEP, and 50.9% expressed interest in more information.

A Review of HIV Pre-exposure Prophylaxis Streamlining Strategies.

PURPOSE OF REVIEW: Standard care for HIV pre-exposure prophylaxis (PrEP) in the USA creates substantial burdens for patients, clinicians, and the healthcare system; to optimize uptake, there is a need for innovative strategies to streamline its provision. RECENT FINDINGS: Our review, structured by the expanded chronic care model, identified eleven promising strategies to streamline PrEP care. Approaches ranged widely in mechanism of action. Using text messages to support care was the only strategy with clinical trial evidence supporting its use. Other modalities such as patient navigation, telemedicine PrEP models, alternate dosing availability, same-day prescription, and provider training have promising pilot or associational data and seem likely to lower barriers to entering into or remaining in care. Many of the strategies have established success in related domains such as HIV care, meriting consideration in evaluating their use for PrEP. Making PrEP care less burdensome will be an important part of bringing it to scale. Text message interventions have proven efficacy and merit broad adoption. Encouraging preliminary evidence for other strategies indicates the importance of building a stronger evidence base to clarify the effect of each strategy. Ongoing development of an evidence base should not delay the use of these promising strategies; instead, it calls for careful consideration for how each program may best match its environment to facilitate PrEP prescribing and use.

PrEP Product Acceptability and Dual Process Decision-Making Among Men Who Have Sex with Men.

PURPOSE OF REVIEW: Advances in short- and long-acting pre-exposure prophylaxis (PrEP) technologies have incentivized the need to understand how individuals make trade-offs and competing decisions regarding PrEP modalities. The purpose of this review was to examine how researchers have conceptualized and measured attributes that are either intuitive and emotional (System 1) or deliberative and cognitive (System 2) in conjoint analysis or discrete choice experiments focused on diverse PrEP technologies among men who have sex with men (MSM). RECENT FINDINGS: Across the 9 studies meeting inclusion criteria, 5 included oral PrEP, 3 included topical rectal microbicides, 4 included PrEP injectables, and 1 study focused on an HIV prevention vaccine. Studies have not used uniform metrics, making comparisons difficult. Researchers measured attributes linked to System 2 processing (e.g., cost, efficacy), yet none examined System 1 processing. There is not one product or attribute preferable to all groups. Prevention products will need to be developed and promoted to reflect that diversity. Given that PrEP technologies have been solely informed by System 2 attributes, efforts to integrate System 1 attributes into ongoing and future PrEP choice experiments are pivotal to advance PrEP acceptability research and interventions to support their implementation.

Artificial Intelligence and Machine Learning for HIV Prevention: Emerging Approaches to Ending the Epidemic.

PURPOSE OF REVIEW: We review applications of artificial intelligence (AI), including machine learning (ML), in the field of HIV prevention. RECENT FINDINGS: ML approaches have been used to identify potential candidates for preexposure prophylaxis (PrEP) in healthcare settings in the USA and Denmark and in a population-based research setting in Eastern Africa. Although still in the proof-of-concept stage, other applications include ML with smartphone-collected and social media data to promote real-time HIV risk reduction, virtual reality tools to facilitate HIV serodisclosure, and chatbots for HIV education. ML has also been used for causal inference in HIV prevention studies. ML has strong potential to improve delivery of PrEP, with this approach moving from development to implementation. Development and evaluation of AI and ML strategies for HIV prevention may benefit from an implementation science approach, including qualitative assessments with end users, and should be developed and evaluated with attention to equity.

US Guideline Criteria for Human Immunodeficiency Virus Preexposure Prophylaxis: Clinical Considerations and Caveats.

Clinical guidelines for human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) developed by the US Centers for Disease Control and Prevention have been instrumental in the implementation of PrEP in medical practices throughout the country. However, the eligibility criteria contained within may inadvertently limit PrEP access for some patients. We describe the following key considerations and caveats related to these criteria: promotion of a selective vs universal approach to sexual health education involving PrEP; misalignment between criteria stated in the table and text boxes; problematic categorization and confounding of sexual orientation, gender identity, and risk behavior; underemphasis of network/community-level drivers of HIV transmission; oversimplification of serodiscordant risk; and lack of clarity surrounding the relevance of condoms to PrEP eligibility. We offer concrete recommendations to address the identified issues and strengthen future iterations of the guidelines, applying these recommendations in an alternative table of "criteria."