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Accepted for/Published in: JMIR Research Protocols

Date Submitted: May 13, 2023
Date Accepted: Aug 15, 2023

The final, peer-reviewed published version of this preprint can be found here:

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

Davis-Ewart L, Grov C, Verhagen R, Manuel J, Viamonte M, Dilworth S, O'Dell N, Valentin O, Carr S, Cherenack E, Doblecki-Lewis S, Nahum-Shani I, Carrico AW

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

JMIR Res Protoc 2023;12:e48459

DOI: 10.2196/48459

PMID: 37831485

PMCID: 10612012

Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot SMART

  • Leah Davis-Ewart; 
  • Christian Grov; 
  • Rachel Verhagen; 
  • Jennifer Manuel; 
  • Michael Viamonte; 
  • Samantha Dilworth; 
  • Nicole O'Dell; 
  • Omar Valentin; 
  • Sidney Carr; 
  • Emily Cherenack; 
  • Susanne Doblecki-Lewis; 
  • Inbal Nahum-Shani; 
  • Adam W. Carrico

ABSTRACT

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.

Objective:

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.

Methods:

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.

Results:

Approximately one in ten (104/1,060) eligible participants enrolled. However, 85% (70/82) of enrolled participants with non-reactive HIV results were randomized.

Conclusions:

Implementation of this pilot SMART underscores the challenges in reaching SMM who use stimulants to optimize HIV prevention. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in SMM who use stimulants Clinical Trial: This protocol was registered on clinicaltrials.gov (NCT04205487) on December 19, 2019.


 Citation

Please cite as:

Davis-Ewart L, Grov C, Verhagen R, Manuel J, Viamonte M, Dilworth S, O'Dell N, Valentin O, Carr S, Cherenack E, Doblecki-Lewis S, Nahum-Shani I, Carrico AW

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

JMIR Res Protoc 2023;12:e48459

DOI: 10.2196/48459

PMID: 37831485

PMCID: 10612012

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