RESUMO
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.
RESUMO
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.
