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.

Leah Davis-Ewart, Christian Grov, Rachel Verhagen, Jennifer Manuel, Michael Viamonte, Samantha Dilworth, Nicole O'Dell, Omar Valentin, Sidney Carr, Emily Cherenack, Chelsea Henderson, Susanne Doblecki-Lewis, Inbal Nahum-Shani, Adam W Carrico
Author Information
  1. Leah Davis-Ewart: Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, United States. ORCID
  2. Christian Grov: Graduate School of Public Health and Health Policy, City University of New York, New York, NY, United States. ORCID
  3. Rachel Verhagen: Department of Psychology, College of Arts and Science, University of Miami, Miami, FL, United States. ORCID
  4. Jennifer Manuel: School of Medicine, University of California, San Francisco, San Francisco, CA, United States. ORCID
  5. Michael Viamonte: Miller School of Medicine, University of Miami, Miami, FL, United States. ORCID
  6. Samantha Dilworth: Miller School of Medicine, University of Miami, Miami, FL, United States. ORCID
  7. Nicole O'Dell: Miller School of Medicine, University of Miami, Miami, FL, United States. ORCID
  8. Omar Valentin: Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, United States. ORCID
  9. Sidney Carr: Miller School of Medicine, University of Miami, Miami, FL, United States. ORCID
  10. Emily Cherenack: Miller School of Medicine, University of Miami, Miami, FL, United States. ORCID
  11. Chelsea Henderson: Miller School of Medicine, University of Miami, Miami, FL, United States. ORCID
  12. Susanne Doblecki-Lewis: Miller School of Medicine, University of Miami, Miami, FL, United States. ORCID
  13. Inbal Nahum-Shani: Institute for Social Research, University of Michigan, Ann Arbor, MI, United States. ORCID
  14. Adam W Carrico: Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, United States. ORCID

Abstract

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.

Keywords

Associated Data

ClinicalTrials.gov | NCT04205487

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Grants

  1. P50 DA054039/NIDA NIH HHS
  2. R01 DA039901/NIDA NIH HHS
  3. R34 DA046367/NIDA NIH HHS

Word Cloud

Created with Highcharts 10.0.0PrEPuseHIVmensexualminoritystimulantsMICMtestingtelehealth1interventionclinicalCASmotivationalinterventionsPRISMrandomizedeffectivenessstimulant2prescriptionpre-exposureprophylaxisMotivationalinterviewingcontingencymanagementpopulationenhancementengagementInterventionspreliminaryassessmentmail-inresultseithersessiondocumentedevidenceevaluationmedicalproviderUS$50fillingfollow-upparticipantsrespondersnonresponderspreventionenrolledUseBACKGROUND:AlthoughsubstantiallymitigateriskcommonlyexperiencedifficultiesengagingservicesreducesubstancecondomlessanalsexrequiremodificationspromotealongcarecontinuumOBJECTIVE:ReadinessSupportingMotivationpilotsequentialmultipleassignmenttrialfeasibilityacceptabilitydistinctcombinations70cisgendercurrentlytakingMETHODS:nationalsamplerecruitedviasocialnetworkingapplicationscompletebaselinenonreactivereceive2-sessionfocusingconcomitantfinancialincentives3-monthreportedfilledsecondtimeswitchsecond-stageieMI+CMCM+MIcontinueassessmentsOutcomesreassessed6-monthprimaryoutcome6monthsSelf-reportedsecondaryoutcomesincludeQualitativeexitinterviewsconductedsubgroupcharacterizeexperiencesRESULTS:ImplementationunderscoreschallengesreachingoptimizeeffortsApproximately10104/1060eligible1048784%completeddelivered5HIV-positiveincludingposttestcounselingreferralsconfirmatoryCONCLUSIONS:Lessonslearnedunderscorecentralimportanceflexibleparticipant-centeredapproachsupportLeveragingplatformsdeliveralsoexpandedreachpotentialpublichealthimpacthigh-priorityresearchneededdeterminesupportingTRIALREGISTRATION:ClinicalTrialsgovNCT04205487https://clinicaltrialsgov/study/NCT04205487INTERNATIONALREGISTEREDREPORTIDENTIFIERIRRID:DERR1-102196/48459EnhancementIncreasePre-ExposureProphylaxisSexualMinorityMenStimulants:ProtocolPilotSequentialMultipleAssignmentRandomizedTrialcocainecondommethamphetaminemotivation

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