HIV-1 Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis: Pooled Analysis From 72 Global Studies.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. RESULTS: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.

Early adopters of doxycycline as post-exposure prophylaxis to prevent bacterial sexually transmitted infections in a real-world clinical setting.

OBJECTIVES: Doxycycline as post-exposure prophylaxis (DoxyPEP) is a novel prevention approach which has demonstrated efficacy in preventing bacterial sexually transmitted infections (STIs) in men who have sex with men (MSM) and transgender women (TGW) including people who are living with HIV and those on HIV pre-exposure prophylaxis (PrEP). We evaluated patient knowledge and interest in DoxyPEP, as well as early adopters of its use. METHODS: In 2023, patients presenting for HIV and STI services at a primary care and sexual health clinic were asked about DoxyPEP knowledge, interest and use. Bivariate and multivariate analyses were used to evaluate demographics and behaviours associated with these outcomes. RESULTS: A total of n=421 people presented for care. Of these, 314 were MSM/TGW. Fifteen percent were Black/African-American, and 21% were Hispanic/Latino. A total of 50% of MSM/TGW had heard of DoxyPEP, 49% were interested and 18% reported prior DoxyPEP use. Having a history of STI infection ever (adjusted OR (aOR) 5.95, 95% CI 2.69 to 13.13) and in the past 12 months (aOR 2.99, 95% CI 1.56 to 5.72) were both associated with DoxyPEP use. Individuals who had ever used HIV PrEP had nearly three times the odds of ever taking DoxyPEP (aOR 2.88, 95% CI 1.56 to 5.30). There was no association between the use of DoxyPEP and race, ethnicity or HIV status. CONCLUSIONS: Among MSM and TGW, there is already significant awareness, interest and use of DoxyPEP to prevent bacterial STIs. Public health efforts should focus on improving access and delivery of this STI prevention intervention to MSM and TGW.

Factors Correlated with Anticoagulation Choice in Primary Care Patients with Atrial Fibrillation and High Stroke Risk.

BACKGROUND: The available data on anticoagulation therapy in real-world primary care settings for atrial fibrillation (AF) patients at high risk of stroke is limited. OBJECTIVE: To evaluate anticoagulation therapy and elucidate the factors associated with the selection between direct oral anticoagulants (DOACs) and warfarin. DESIGN AND PARTICIPANTS: This is a retrospective cohort study that included patients ≥ 18 years old at a large primary care outpatient group, a network of twenty clinics in the northeast United States between January 4, 2021 - January 4, 2023. MAIN MEASURES: Oral anticoagulation therapy in AF patients with high risk of stroke (CHA2DS2-VASc score of ≥ 2 in men or ≥ 3 in women). KEY RESULTS: Among the 3,118 adult patients with AF and high risk of stroke (median age 77.90, IQR 71.66-84.50 years; male 57.6%), we found that older age (aOR 1.40, p = 0.003), greater BMI (25-29.9: aOR 1.32, p = 0.048; ≥ 30 aOR 1.42, p = 0.010), and taking more than five medications (aOR 2.28, p < 0.001) were more likely to be on an oral anticoagulant. Among those taking an OAC, having Medicare as the sole coverage (aOR 0.53, p = 0.032), male gender (aOR 0.69, p = 0.011), worse renal function (aOR 0.80, p = 0.021), and higher CHA2DS2-VASc score (aOR 0.88, p = 0.024) are more likely to be on warfarin than a DOAC. Patients taking more than five medications daily (6-10 medications: aOR 1.92, p = 0.013; ≥ 16: aOR = 2.10, p = 0.006) were more likely to be on an anticoagulant and may receive a DOAC over warfarin. CONCLUSIONS: AF with high stroke risk adult patients are more likely to be on an oral anticoagulant if they are older, having BMI ≥ 25, or taking more than five medications. Medicare as the sole coverage, male gender, worse renal function, and higher CHA2DS2-VASc scores are factors associated with greater warfarin usage, while patients taking over five daily medications are more likely to be prescribed DOACs.

Implementation of Point of Care Sexually Transmitted Infections Testing in a Community Clinic Setting.

ABSTRACT: The rates of sexually transmitted infections (STIs) in the United States, including chlamydia and gonorrhea, are rising. Point-of-care (POC) testing could increase access to testing and treatment. This evaluation found POC STI testing to be concordant with the results of traditional laboratory testing for 100% of patients who were tested. Ninety-five percent of the patients reported being satisfied with the experience, and 66% preferred it to traditional laboratory testing. The most commonly reported reason for preferring the test was the short amount of time it took to receive results. However, insurance reimbursed less than 30% of what was billed for the POC tests. Low insurance reimbursement rates could be a barrier to implementation long-term financial sustainability of POC STI testing.

Characterizing Interest in and Uptake of Preexposure Prophylaxis for HIV Prevention Among Men in a US State Correctional System.

BACKGROUND: People experiencing incarceration are disproportionately impacted by HIV and are potential candidates for HIV preexposure prophylaxis (PrEP). We explored factors associated with PrEP interest and PrEP uptake and described barriers to PrEP uptake among incarcerated men in a state correctional system. METHODS: From September 2019 to July 2022, incarcerated men at the Rhode Island Department of Corrections were screened for PrEP eligibility and referred to a PrEP initiation study. We used bivariate analyses and multivariable logistic regression models to explore factors associated with PrEP interest and uptake in the screening sample. RESULTS: Of the men screened and determined to be eligible for PrEP, approximately half (50%) were interested in taking PrEP. Individuals identifying as men who have sex with men (adjusted odds ratio, 4.46; 95% confidence interval, 1.86-11.4) and having multiple female sex partners (adjusted odds ratio, 2.98; 95% confidence interval, 1.47-6.27) were more likely to express interest in PrEP (interested/not interested) than those not reporting these behavioral factors. Preexposure prophylaxis uptake (yes/no) was 38%. Lack of PrEP interest, low self-perceived risk of HIV acquisition, and unpredictable lengths of incarceration were the most frequently encountered barriers to PrEP uptake. CONCLUSIONS: Men reporting sexual transmission behaviors were more interested in PrEP and had higher uptake than other men. Preexposure prophylaxis interest and HIV risk factors were both moderately high, which suggests that men experiencing incarceration should be screened for and offered PrEP as part of standard clinical care. Study findings have important implications for research and practice to adapt PrEP care to correctional systems.

Pilot Randomized Controlled Trial of Game Plan for PrEP: A Brief, Web and Text Message Intervention to Help Sexual Minority Men Adhere to PrEP and Reduce Their Alcohol Use.

Suboptimal adherence to oral PrEP medications, particularly among younger sexual minority men (SMM), continues to be a key barrier to achieving more substantial declines in new HIV infections. Although variety of interventions, including web and text-message-based applications, have successfully addressed PrEP adherence, very few have addressed the potential influence of alcohol. This pilot study explored whether the Game Plan for PrEP, a brief, web-based and text messaging intervention, helped promote PrEP persistence and adherence and reduced condomless sex and alcohol use. Seventy-three heavy-drinking SMM on PrEP were recruited online from states with Ending the HIV Epidemic jurisdictions and randomly assigned 1:1 to receive either the Game Plan for PrEP intervention or an attention-matched control. We collected online surveys assessing primary outcomes at one, three, and six months post-enrollment. As secondary outcomes, we also collected dried blood spot samples at baseline, three, and six months to analyze for biomarkers of PrEP and alcohol use. Our results showed that the odds of stopping PrEP or experiencing a clinically meaningful lapse in PrEP adherence (≥ 4 consecutive missed doses) were not different across the two conditions. We also did not find evidence of any differences in condomless sex or drinking outcomes across conditions, although participants in both conditions reported drinking less often over time. These findings were consistent across both self-reported outcomes and biomarkers. Overall, we did not find evidence that our brief, web and text messaging intervention encouraged more optimal PrEP coverage or moderate their alcohol use.

Identifying HIV PrEP Attributes to Increase PrEP Use Among Different Groups of Gay, Bisexual, and Other Men Who Have Sex with Men: A Latent Class Analysis of a Discrete Choice Experiment.

Daily pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV among gay, bisexual, and other men who have sex with men (GBMSM), although uptake remains suboptimal. By identifying the features of PrEP that appeal to various subgroups of GBMSM, this study aimed to improve PrEP uptake by examining preferences for PrEP use. Adults ≥ 18 years old in six New England states completed an online discrete choice experiment survey. A latent class analysis (LCA) was conducted to identify groups of GBMSM based on four attributes of choices for PrEP (cost, time, side effects, and mode of administration). Multinominal logistic regression was conducted to compare the association between sociodemographic and behavioral characteristics and class memberships. Data from 675 GBMSM were analyzed. A 3-Class model was selected as the best fit model. Class 1 (47.7% of individuals) was identified as having "no specific preferences". Class 2 (18.5% of individuals) were "Cost- and time-conscious" and were significantly more likely to be older, have prior sexually transmitted infection (STI) testing, have low household income, private insurance, and have extreme concerns about HIV risk than those with no specific preference (Class 1). Finally, Class 3 (34.1% of individuals) were "Side effects-conscious" and were more likely to have low income, private insurance, and have moderate and extreme concerns about HIV risk than those with no specific preference (Class 1). Findings indicate that outreach to GBMSM who have never used PrEP should emphasize low cost and short travel times to increase potential PrEP use.

"Make it more than a pill, make it an experience of health:" results from an open pilot intervention to retain young African American men who have sex with men in PrEP care.

Uptake and retention in clinical care for pre-exposure prophylaxis (PrEP) is suboptimal, particularly among young African American men who have sex with men (MSM) in the Deep South. We conducted a two-phase study to develop and implement an intervention to increase PrEP persistence. In Phase I, we conducted focus groups with 27 young African American MSM taking PrEP at a community health center in Jackson, Mississippi to elicit recommendations for the PrEP persistence intervention. We developed an intervention based on recommendations in Phase I, and in Phase II, ten participants were enrolled in an open pilot. Eight participants completed Phase II study activities, including a single intervention session, phone call check-ins, and four assessments (Months 0, 1, 3, and 6). Exit interviews demonstrated a high level of acceptability and satisfaction with the intervention. These formative data demonstrate the initial promise of a novel intervention to improve PrEP persistence among young African American MSM.

Study protocol of a randomized controlled trial to assess the efficacy of the "PrEPare for Work" intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S.

BACKGROUND: Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as "sex workers." This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs' unique life circumstances and provide support in exploring their sexual health options are needed. METHODS: In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of "PrEPare for Work,"- a theory-based, manualized PrEP uptake and adherence intervention for MSW - using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the "PrEPare for Work Stage 1 intervention" (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the "PrEPare for Work Stage 2 intervention" (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. DISCUSSION: Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs' unique life circumstances are urgently needed. In this study, we are evaluating whether "PrEPare for Work" can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT05736614, registered February 8, 2023.

Characterizing Social Connectedness and Associated Mental Health Symptoms among Sexual Minority Men Enrolled in a Substance Use Recovery Support Program.

BACKGROUND: Sexual minority men (SMM; gay, bisexual, and other men who have sex with men) report higher rates of substance use compared to other populations. Social connectedness is a critical component for promoting and maintaining recovery from substance use disorders. However, the degree of social connectedness among SMM who report substance use is largely unknown. OBJECTIVES: We examined substance use, social connectedness (past 30-d participation in formal recovery support, past 30-d interaction with supportive family/friends, relationship satisfaction, and types of support) and mental health among SMM at the time of their enrollment in a behavioral substance use program from September 2019 to October 2021. RESULTS: Of the107 SMM, 80% of the sample reported past 30-d illicit substance use, with methamphetamine representing the most commonly reported drug used (53%). Participants used a variety of social connections for support, including self-help groups (44% voluntary; 5% religious-affiliated; 20% other) and family/friends (81%). Importantly, 15% reported they had no one to turn to when having trouble and 36% were either dissatisfied or very dissatisfied with their relationships. Participants who endorsed significant depressive (58%) and anxiety (70%) symptoms were more likely to endorse relationship dissatisfaction than participants who did not endorse symptoms (p < 0.01). CONCLUSIONS: One-third of SMM enrolled in a substance use recovery program expressed relationship dissatisfaction, particularly those struggling with depression or anxiety. Future research and programming should examine ways of leveraging existing social connectedness or forging new social supports to enhance mental health and substance use recovery for SMM using substances.

A Description of Telehealth Use Among Sexually Transmitted Infection Providers in the United States, 2021.

BACKGROUND: Telehealth offers one approach to improving access to sexually transmitted infection (STI) prevention and care services. Therefore, we described recent telehealth use among those providing STI-related care and identified opportunities for improving STI service delivery. MATERIALS AND METHODS: Using the DocStyles Web-based, panel survey conducted by Porter Novelli from September 14 to November 10, 2021, 1500 healthcare providers were asked about their current telehealth usage, demographics, and practice characteristics, and compared STI providers (≥10% of time spent on STI care and prevention) to non-STI providers. RESULTS: Among those whose practice consisted of at least 10% STI visits (n = 597), 81.7% used telehealth compared with 75.7% for those whose practice consisted of less than 10% STI visits (n = 903). Among the providers with at least 10% STI visits in their practice, telehealth use was highest among obstetrics and gynecology specialists, those practicing in suburban areas, and those practicing in the South. Among providers whose practice consisted of at least 10% STI visits and who used telehealth (n = 488), the majority were female and obstetrics and gynecology specialists practicing in suburban areas of the South. After controlling for age, gender, provider specialty, and geographic location of their practice, providers whose practice consisted of at least 10% STI visits had increased odds (odds ratio, 1.51; 95% confidence interval, 1.16-1.97) of using telehealth compared with providers whose visits consisted of less than 10% STI visits. CONCLUSIONS: Given the widespread use of telehealth, efforts to optimize delivery of STI care and prevention via telehealth are important to improve access to services and address STIs in the United States.

Safety of Longer-Term Doxycycline Use: A Systematic Review and Meta-Analysis With Implications for Bacterial Sexually Transmitted Infection Chemoprophylaxis.

BACKGROUND: Sexually transmitted infections (STIs) such as syphilis, gonorrhea, and chlamydia have significantly increased over the past decade in the United States. Doxycycline as chemoprophylaxis (i.e., postexposure prophylaxis) offers promise for addressing bacterial STIs. The goal of the current study was to evaluate the safety of longer-term doxycycline use (defined as 8 or more weeks) in the context of potential use as STI chemoprophylaxis through a systematic literature review and meta-analysis. METHODS: This review used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to search MEDLINE/PubMed for clinical studies published from August 2003 to January 2023 that reported on adverse events with doxycycline use with a focus on side effects and metabolic effects of long-term use. RESULTS: A total of 67 studies were included in the systematic review. Overall, studies on longer-term doxycycline use reported 0% to greater than 50% adverse events ranging from mild to severe. Most common adverse events included gastrointestinal symptoms (i.e., nausea, vomiting, and abdominal pain), dermatologic (i.e., rash), and neurological (i.e., headache and dizziness) symptoms. Discontinuation of doxycycline due to adverse events was relatively uncommon in most studies. A meta-analysis of placebo controlled clinical trials (N = 18) revealed that gastrointestinal and dermatological adverse events were more likely to occur in the doxycycline group. CONCLUSIONS: Longer-term (8+ weeks) doxycycline use is generally safe and may be associated with minor side effects. Further research is needed on the potential metabolic impact of longer-term doxycycline use.

Sexually Transmitted Infections Risk and Interstate Sexual Networks Among Men Who Have Sex With Men in New England.

ABSTRACT: By investigating relationships between sexual mobility and sexual transmitted infection (STI) risk factors among men who have sex with men, we found that STI history, number of sexual partners, and substance use are associated with increased odds of interstate sexual encounters, suggesting that interjurisdictional approaches to STI prevention are needed.

Optimizing Uptake of Long-Acting Injectable Pre-exposure Prophylaxis for HIV Prevention for Men Who Have Sex with Men.

Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention tool. Long-acting injectable PrEP (LAI-PrEP) offers another opportunity to reduce HIV. However, how at-risk individuals will consider LAI-PrEP over other modes of administration is unclear. We conducted a discrete choice experiment on preferences for PrEP among a sample of N = 688 gay, bisexual, and other men who have sex with men (GBMSM). We analyzed preferences for mode of administration, side-effects, monetary cost, and time cost using a conditional logit model and predicted preference for PrEP options. LAI-PrEP was preferred, despite mode of administration being the least important PrEP attribute. Side-effects were the most important attribute influencing preferences for PrEP (44% of decision); costs were second-most-important (35% of decision). PrEP with no side-effects was the most important preference, followed by monthly out-of-pocket costs of $0. Practitioners and policymakers looking to increase PrEP uptake should keep costs low, communicate clearly about PrEP side-effects, and allow the use of patient-preferred modes of PrEP administration, including LAI-PrEP.

RESUMEN: La profilaxis prexposición (PrEP) es una herramienta de prevención del VIH muy eficaz. La PrEP inyectable de acción prolongada (LAI-PrEP) ofrece otra oportunidad para reducir el VIH. Sin embargo, no está claro cómo las personas en riesgo considerarán LAI-PrEP sobre otros modos de administración. Realizamos un experimento de elección discreta sobre las preferencias por la PrEP entre una muestra de N = 688 hombres homosexuales, bisexuales y otros hombres que tienen sexo con hombres (GBMSM). Analizamos las preferencias por el modo de administración, los efectos secundarios, el costo monetario y el costo del tiempo mediante un modelo logit condicional y la preferencia prevista por las opciones de PrEP. Se prefirió LAI-PrEP, a pesar de que el modo de administración es el atributo de PrEP menos importante. Los efectos secundarios fueron el atributo más importante que influyó en las preferencias por la PrEP (44% de la decisión); los costos fueron los segundos más importantes (35% de la decisión). La PrEP sin efectos secundarios fue la preferencia más importante, seguida de costos de bolsillo mensuales de $0. Los médicos y legisladores que buscan aumentar la aceptación de la PrEP deben mantener los costos bajos, comunicar claramente los efectos secundarios de la PrEP y permitir el uso de los modos de administración de la PrEP preferidos por los pacientes, incluido LAI-PrEP.

Characterizing HIV Syndemics and the Role of Incarceration Among Men Who have Sex with Men Presenting for Care at a Sexually Transmitted Infections Clinic.

Men who have sex with men (MSM) with a history of incarceration experience unique risk factors for HIV acquisition. The current study examined unique risk factors for HIV among MSM with a history of incarceration presenting to a sexually transmitted infections (STI) clinic. We analyzed self-reported behavioral data from clinical encounters among patients attending the clinic between January 2012 and April 2021. There were 17,221 unique visits, of which 5988 were MSM. Of these, 4.34% (N = 206) were MSM with a history of incarceration. MSM with a history of incarceration were significantly more likely to report a range of behavioral risk factors for HIV, yet also were significantly less likely to perceive themselves at risk for HIV. Future research and practice should develop culturally tailored biobehavioral HIV prevention services and consider embedding these programs within criminal justice settings to better reach this at-risk group.

Same-Sex Marriage Laws, Provider-Patient Communication, and PrEP Awareness and Use Among Gay, Bisexual, and Other Men Who have Sex with Men in the United States.

State-level structural stigma and its consequences in healthcare settings shape access to pre-exposure prophylaxis (PrEP) for HIV prevention among gay, bisexual, and other men who have sex with men (GBMSM). Our objective was to assess the relationships between same-sex marriage laws, a measure of structural stigma at the state level, provider-patient communication about sex, and GBMSM awareness and use of PrEP. Using data from the Fenway Institute's MSM Internet Survey collected in 2013 (N = 3296), we conducted modified Poisson regression analyses to evaluate associations between same-sex marriage legality, measures of provider-patient communication, and PrEP awareness and use. Living in a state where same-sex marriage was legal was associated with PrEP awareness (aPR 1.27; 95% CI 1.14, 1.41), as were feeling comfortable discussing with primary care providers that they have had sex with a man (aPR 1.63; 95% CI 1.46, 1.82), discussing with their primary care provider having had condomless sex with a man (aPR 1.65; 95% CI 1.49, 1.82), and discussing with their primary care provider ways to prevent sexual transmission of HIV (aPR 1.39; 95% CI 1.26, 1.54). Each of these three measures of provider-patient communication were additionally associated with PrEP awareness and use. In sum, structural stigma was associated with reduced PrEP awareness and use. Policies that reduce stigma against GBMSM may help to promote PrEP and prevent HIV transmission.

PrEPare for Work: A Pilot Randomized Controlled Trial of an Intervention to Optimize HIV PrEP Outcomes Among Male Sex Workers.

HIV pre-exposure prophylaxis (PrEP) use is limited among male sex workers, who are at exceptionally high-risk for HIV infection. We developed a theory-informed, two-pronged intervention ("PrEPare-for-Work") to optimize PrEP initiation and adherence among male sex workers, which was preliminarily evaluated in a two-stage pilot randomized controlled trial of 110 male sex workers in the US Northeast. Individuals randomized to the Stage 1 PrEPare-for-Work Case Management arm were three times as likely as those in the standard of care (SOC) arm to initiate PrEP (RR = 2.95, 95% CI = 1.57-5.57). Participants who initiated PrEP and were randomized to the Stage 2 PrEPare-for-Work Adherence Counseling arm had higher rates of prevention-effective adherence (measured via tenofovir in hair) compared to those in the SOC arm (RR = 1.7, 95% CI 0.64-4.77; 55.6% vs. 28.6%, respectively); though not statistically significant. Given the need and the promise of this pilot RCT, further efficacy testing is warranted and should be prioritized.

RESUMEN: El uso de la profilaxis prexposición (PrEP) para prevenir la adquisición del VIH es limitado entre trabajadores sexuales masculinos, que están en muy alto riesgo de contraerlo. Desarrollamos una intervención de dos partes basada en la teoría para optimizar el inicio y la observancia del tratamiento de la PrEP entre trabajadores sexuales masculinos, que se evaluó preliminarmente en un ensayo piloto controlado y aleatorizado (ECA) de dos fases de 110 trabajadores sexuales masculinos en el noreste de Estados Unidos. Las personas aleatorizadas al grupo de intervención (la primera fase de nuestro programa "PrEPare for Work" ­ la atención individualizada) eran tres veces más probable que las aleatorizadas al grupo control (la norma de atención) a iniciar la PrEP (RR = 2.95, 95% IC = 1.57­5.57). Los participantes que iniciaron la PrEP y se aleatorizaron al grupo de intervención (la segunda fase de "PrEPare for Work" ­ la terapia para aumentar la adherencia al tratamiento) tenían tasas más altas de adherencia al tratamiento (medido por tenofovir en el cabello) que los aleatorizados al grupo control (RR = 1.7, 95% IC 0.64­4.77; 55.6% vs. 28.6%, respectivamente); aunque la diferencia no fue estadísticamente significativa. En vista de la necesidad y el potencial de este ECA piloto, más pruebas de eficacia son necesarias y deben ser priorizadas.

Factors associated with suboptimal retention in HIV pre-exposure prophylaxis care among men who have sex with men.

Despite the efficacy of HIV pre-exposure prophylaxis (PrEP), retention in care in the United States remains suboptimal. The goal of this study was to explore factors that lead to suboptimal retention in PrEP care for men who have sex with men (MSM) in real-world clinical settings in the United States. Trained interviewers conducted semi-structured interviews with MSM (N = 49) from three clinics who had been engaged in PrEP care in the Midwest (n = 15), South (n = 15), and Northeast (n = 19) geographic regions and had experienced a lapse in PrEP use. Factors that emerged as related to suboptimal retention in PrEP care included structural factors such as transportation and out-of-pocket costs; social factors such as misinformation on media and in personal networks; clinical factors such as frequency and timing of appointments; and behavioral factors such as changes in sexual behavior and low perceived risk for HIV. Participants suggested reducing the out-of-pocket costs of medications and lab visits, having flexible appointment times, culturally responsive services, and comprehensive patient navigation to help retention in care. These findings leveraged real-world experiences and opinions of patients to inform gaps in current services and how to make changes to optimize PrEP care.

Co-occurring mental health and drug use experiences among Black and Hispanic/Latino sexual and gender diverse individuals.

Black and Hispanic/Latino sexual and gender diverse individuals disproportionately experience overlapping health disparities, such as drug use and elevated depressive symptoms, which are often driven by minority stressors. We sought to better understand the interaction between drug use and mental health, as it may be fruitful in developing effective interventions to address co-occurring health disparities. In a longitudinal, 5-wave sample of 300 Black and Hispanic/Latino sexual and gender diverse (SGD) individuals collected between March 2020 and March 2022, we found a within-person association between greater than average levels of psychological distress (depression and anxiety) and more frequent extra-medical use of cannabis, inhalants, methamphetamines, and opioids over the span of two years. These associations held after adjusting for the direct, within-person association of internalized homonegativity with drug use frequency. These results suggest that psychological distress explains at least some variance in drug use among Black and Hispanic/Latino SGD individuals. This highlights the importance of interventions that focus on mental health among Black and Hispanic/Latino SGD individuals who report drug use.

Perspectives of a peer-driven approach to improve pre-exposure prophylaxis and HIV prevention among Black/African American and Hispanic/Latino men who have sex with men.

BACKGROUND: Black/African American (B/AA) and Hispanic/Latino (H/L) men who have sex with men (MSM) are significantly less likely than white MSM to initiate pre-exposure prophylaxis (PrEP). A peer-driven intervention (PDI) may be an effective approach to addressing this disparity. In this study, we explored community member perspectives of a PDI to promote PrEP uptake among B/AA and H/L MSM. METHODS: We conducted semi-structured interviews with B/AA and H/L HIV-negative MSM between August 2018 and October 2019 in Rhode Island, USA. Participants reported their perspectives and recommendations for a PDI. Data from participant responses were thematically analysed. RESULTS: Of 15 MSM, the median age was 25years (interquartile range: 22, 33). The majority identified as B/AA (53.3%), H/L (66.7%), and having a college education or above (53.3%). Most participants viewed a PDI positively and were willing to learn and promote PrEP among their peers. Participants identified and supported several potential intervention components, such as education about the benefit of PrEP, emphasising prevention-effective dosing, and clarifying no prevention effect towards other sexually transmitted infections. They preferred in-person meetings to electronic communication. Preferred characteristics of peer educators included compassion, good communication skills, and enthusiasm about PrEP. CONCLUSIONS: This in-depth qualitative interview suggested that a PDI approach is promising in promoting PrEP uptake, as it could deliver culturally appropriate education and encourage PrEP uptake via peer influence among B/AA and H/L MSM.