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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.

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. [ABSTRACT FROM AUTHOR]

Background: As in much of the United States, there have been significant increases in overdose deaths among non-Hispanic Black and Hispanic/Latinx populations in Rhode Island over the past decade. Given the shifting dynamics of the overdose epidemic, there is an urgent need for focused interventions that address the specific needs of diverse communities. This study explores differences in drug use patterns, harm reduction behaviors and types and barriers to treatment by race and ethnicity., Methods: This study utilized baseline data from the Rhode Island Prescription and Illicit Drug Study (RAPIDS). We assessed sociodemographic characteristics, drug use patterns, harm reduction practices, treatment type, and barriers to treatment in a cross-sectional analysis of people who use drugs (PWUD), stratified by race and ethnicity (non-Hispanic white, non-Hispanic Black, non-Hispanic other race, and Hispanic). Chi-square tests of independence and ANOVA tests were used to identify statistically significant differences by race and ethnicity., Results: Among 509 participants, the median age was 43, and the majority were men (64%). Non-Hispanic Black participants reported significantly less regular use of unregulated opioids, such as heroin (10%) and fentanyl (12%), as compared to non-Hispanic white participants (39% and 33%, respectively). Non-Hispanic Black participants reported significantly less experience responding to overdoses: only 39% had ever administered naloxone and 34% had ever performed rescue breathing, as compared to 67% and 57% among non-Hispanic white participants, respectively. Despite significant differences in drug use patterns, there were few differences in harm reduction practices by race and ethnicity. Current treatment enrollment was highest among those who were non-Hispanic white (38%) and lowest among those who were non-Hispanic Black (7%)., Conclusions: These findings suggest that there are differences in overdose response experience and treatment exposure between non-Hispanic Black PWUD and those belonging to other racial and ethnic groups, indicating a need for enhanced investment in overdose response education, naloxone distribution and treatment access for non-Hispanic Black PWUD., Competing Interests: Competing interests Dr. Biello reports receiving unrestricted research funds from Merck outside the submitted work. Dr. Sherman is an expert witness in ongoing opioid litigation. No other co-authors have interests to disclose.