Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial.

BACKGROUND: Although pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce substance use and condomless anal sex (CAS) in this population, but these motivational enhancement interventions require modifications to promote engagement along the PrEP care continuum. OBJECTIVE: PrEP Readiness Interventions for Supporting Motivation (PRISM) is a pilot sequential multiple assignment randomized trial testing the feasibility, acceptability, and preliminary effectiveness of distinct combinations of telehealth MI and CM in 70 cisgender sexual minority men who use stimulants that are not currently taking PrEP. METHODS: A national sample was recruited via social networking applications to complete a baseline assessment and mail-in HIV testing. Those with nonreactive HIV results were randomized to receive either (1) a 2-session MI intervention focusing on PrEP use (session 1) and concomitant stimulant use or CAS (session 2) or (2) a CM intervention with financial incentives for documented evidence of PrEP clinical evaluation by a medical provider (US $50) and filling a PrEP prescription (US $50). At the 3-month follow-up assessment, participants who reported they had not filled a prescription for PrEP were randomized a second time to either (1) switch to a second-stage intervention (ie, MI+CM or CM+MI) or (2) continue with assessments only. Outcomes for both responders and nonresponders were reassessed at a 6-month follow-up. The primary outcome is documented evidence of filling a PrEP prescription over 6 months. Self-reported secondary outcomes include PrEP clinical evaluation by a medical provider, stimulant use, and CAS. Qualitative exit interviews were conducted with a subgroup of responders and nonresponders to characterize their experiences with the MI and CM interventions. RESULTS: Implementation of PRISM underscores challenges in reaching sexual minority men who use stimulants to optimize HIV prevention efforts. Approximately 1 in 10 (104/1060) eligible participants have enrolled. Of the 104 who enrolled, 87 (84%) completed mail-in HIV testing. We delivered 5 preliminary HIV-positive results, including posttest counseling with referrals to confirmatory testing. CONCLUSIONS: Lessons learned from PRISM underscore the central importance of a flexible, participant-centered approach to support the engagement of sexual minority men who use stimulants. Leveraging telehealth platforms to deliver motivational enhancement interventions also expanded their reach and potential public health impact with this high-priority population. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in sexual minority men who use stimulants. TRIAL REGISTRATION: ClinicalTrials.gov NCT04205487; https://clinicaltrials.gov/study/NCT04205487. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48459.

Randomized Controlled Trial of Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants.

Background: Although pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men (SMM) who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce substance use and condomless anal sex in this population, but these motivational enhancement interventions require adaptation to promote engagement along the PrEP care continuum. Methods: PRISM is a pilot sequential multiple assignment randomized trial (SMART) testing the feasibility, acceptability, and preliminary effectiveness of distinct combinations of telehealth MI and CM in 70 cisgender SMM who use stimulants that are not currently taking PrEP. A national sample was recruited via social networking applications to complete a baseline assessment and mail-in HIV testing. Those with non-reactive HIV results are randomized to receive either: 1) a 2-session MI intervention focusing on PrEP use (session 1) and concomitant stimulant use or condomless anal sex (session 2); or 2) a CM intervention with financial incentives for documented evidence of PrEP clinical evaluation by a medical provider ($50) and filling a PrEP prescription ($50). At the 3-month follow-up assessment, participants who report they have not filled a prescription for PrEP are randomized a second time to either: 1) Switch to a second-stage intervention (i.e., MI + CM or CM + MI); or 2) Continue with assessments only. Outcomes for both responders and non-responders are reassessed at a 6-month follow-up. The primary outcome is documented evidence of filling a PrEP prescription. Self-reported, secondary outcomes include PrEP clinical evaluation by a medical provider, stimulant use, and condomless anal sex. Qualitative exit interviews are conducted with a sub-group of responders and non-responders to characterize their experiences with the MI and CM interventions. Discussion: Implementation of this pilot SMART underscores the challenges in reaching SMM who use stimulants to optimize HIV prevention efforts such that approximately one in ten (104/1,060) eligible participants enrolled. However, 85% (70/82) of enrolled participants with non-reactive HIV results were randomized. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in SMM who use stimulants. Trial Registration: This protocol was registered on clinicaltrials.gov (NCT04205487) on December 19, 2019.

Feasibility and Acceptability Pilot Test of Connecting Latinos en Parejas: A Couples-Based HIV Prevention Intervention for Latino Male Couples.

Despite recent emphasis on couples-based HIV prevention interventions, efficacious interventions for Latino male couples have yet to be tested. The study examined the feasibility and acceptability of the Connecting Latinos en Pareja (CLP) intervention, a couples-based HIV prevention intervention for Latino male couples. This pilot demonstrated high feasibility, meeting targets for recruitment, retention, and intervention completion. We recruited a diverse cohort of 46 individuals/23 couples with a retention rate of 80% over 6 months and a 100% intervention completion rate in both conditions (four structured couple sessions in each condition). This pilot RCT was not powered to detect significant intervention impact on the primary outcome; however, there was a significant increase in relationship functioning among couples in the intervention group relative to controls and promising trends in changes in several key outcome and mediating variables. Secondary analysis documented trends in the expected directions for several other key hypothesized mechanisms of action (stimulant use, psychological symptoms, quality of life) as well as the primary outcome of proportion of protected sex acts (overall and broken out by main vs. outside partners). Qualitative exit interviews revealed high levels of acceptability of the CLP intervention. Participants highlighted affective component of the intervention and perceived effectiveness in improving dyadic communication skills and safer sex practices. Our findings show that a pilot trial of CLP is highly feasible and acceptable, with CLP demonstrating promising evidence of changes in key intervention mechanisms.

More than just oral PrEP: exploring interest in rectal douche, dissolvable implant, removable implant and injection HIV prevention approaches among racially diverse men who have sex with men in the Northeast Corridor.

OBJECTIVES: HIV scholars and practitioners have worked to expand strategies for prevention among marginalised populations who are disproportionately impacted by the epidemic, such as racial minority men who have sex with men (MSM). Given this urgency, the objective of this study was to assess interest in biomedical prevention strategies. METHODS: This exploratory and cross-sectional study investigated interest in four biomedical prevention tools-rectal douche, dissolvable implant, removable implant and injection-among a racially diverse sample of MSM from the Northeast Corridor region between Philadelphia and Trenton. Data were collected as part of screening for Connecting Latinos en Pareja, a couples-based HIV prevention intervention for Latino MSM and their partners. RESULTS: A total of 381 individuals participated in the screener and provided information about their interest in bio tools. Approximately 26% of participants identified as black, 28% as white and 42% as 'other' or multiracial; 49% identified as Latino. Majority (54%) reported some form of child sexual abuse. Of the participants who reported being in a primary relationship (n=217), two-thirds reported unprotected anal sex within that relationship over the past 90 days (n=138, 64%) and approximately half (n=117, 54%) reported unprotected anal sex outside of the relationship in this period. Majority of participants reported interest in all bio tools assessed, including dissolvable implants (60%), removable implants (64%), rectal douching (79%) and injection (79%). Although interest in bio tools was broadly unassociated with demographics and sexual risk behaviours, analyses revealed significant associations between reports of child sexual abuse and interest in implant and injection methods. CONCLUSIONS: The authors recommend investing in these prevention methods, particularly rectal douching and injection, as a means of preventing HIV among racial minority MSM. Given the interest in biomedical prevention tools, future studies should explore potential strategies for adherence.

A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial.

BACKGROUND: Latino men who have sex with men (MSM) experienced a 13% increase in HIV diagnoses from 2010 to 2014, more than any other racial/ethnic subgroup of MSM in the United States. If current HIV diagnoses rates persist, about one in four Latino MSM in the United States will be diagnosed with HIV during their lifetime. Although some efficacious HIV prevention interventions for Latino MSM exist, none have focused on couples. This paper describes the protocol of a randomized controlled trial (RCT) to test the preliminary efficacy of a couple-based HIV prevention intervention that is culturally tailored for Latino men and their same-sex partners. METHODS: The RCT will determine the preliminary efficacy of Connecting Latinos en Pareja (CLP) to increase the proportion of anal sex acts that are HIV protected (i.e., anal sex acts in which condoms, pre-exposure prophylaxis (PrEP), treatment as prevention (TasP), or a combination thereof, are used to reduce risk of HIV transmission). CLP builds upon previous couple-based interventions with white and black MSM by incorporating biomedical prevention techniques, such as PrEP and TasP, implementing a framework responsive to the couple's serostatus, and addressing the socio-cultural factors that influence HIV risk among Latino MSM. We also include input from community stakeholders, members of the target population, and a community advisory board as part of intervention development. Assessments will be conducted at baseline, and 3- and 6-months post-intervention to examine the intervention effects on outcomes (HIV-protected sex acts), and factors potentially mediating or moderating intervention effects. DISCUSSION: This paper describes an innovative RCT that incorporates multiple HIV prevention techniques for Latino MSM in couples, regardless of serostatus. The ongoing involvement of community stakeholders, members of the target population, and a community advisory board is emphasized, and plans for widespread dissemination and application of findings into practice are discussed. TRIAL REGISTRATION: Trial registration: NCT03048838 . Registered on 3 February 2017.