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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Dec 3, 2018
Date Accepted: May 10, 2019
(closed for review but you can still tweet)

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

Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol

Starks TJ, Robles G, Pawson M, Jimenez RH, Gandhi M, Parsons JT, Millar BM

Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol

JMIR Res Protoc 2019;8(7):e13015

DOI: 10.2196/13015

PMID: 31274114

PMCID: 6637725

Motivational Interviewing to reduce drug use and HIV incidence among high PrEP priority YMSM in relationships (Project PARTNER): A randomized controlled trial protocol

  • Tyrel J. Starks; 
  • Gabriel Robles; 
  • Mark Pawson; 
  • Ruben H. Jimenez; 
  • Monica Gandhi; 
  • Jeffrey T. Parsons; 
  • Brett M. Millar

ABSTRACT

Background:

Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the U.S. , and, among young MSM aged 20-29, as many as 79-84% of new infections occur between primary partners. Contributing to HIV risk, young MSM use drugs at comparatively high rates. To date, no interventions have been developed which specifically address the unique needs of partnered YMSM or incorporate a focus on relationship factors in addressing personal motivation for change.

Objective:

This study seeks to evaluate the efficacy of PARTNER (Prevention and Risk: Treatment with a New Emphasis on Relationships), a motivational interviewing -based intervention which integrates video-based communication skills training to address drug use and HIV prevention among partnered YMSM, including PrEP uptake and adherence; and to evaluate potential moderators or mediators of intervention efforts. Secondarily, we will explore the potential to develop and validate a novel biomarker for PrEP adherence by analyzing PrEP drug levels in fingernails.

Methods:

This study utilizes a randomized controlled trial design to compare the 4-session PARTNER intervention to an attention-matched psychoeducation control arm with follow-up assessments conducted at 3-, 6-, 9- and 12-months post-baseline. The study will recruit and enroll 240 partnered YMSM between the ages 18-29. Participants will be HIV-negative, and will report recent (past 30-day) drug use and either condomless anal sex (CAS) with a casual partner; a non-monogamous primary partner (regardless of HIV status); or a sero-discordant primary partner (regardless of sexual agreement). Self-report drug use and sexual behavior data are gathered via Timeline Follow-back interview. Biological samples are collected for drug use (fingernail assay), sexual HIV transmission risk (rectal and urethral gonorrhea and chlamydia testing) and PrEP adherence (dried blood spots and fingernails for a novel PrEP drug level assay).

Results:

Project PARTNER has been open to enrollment since February, 2018. Enrollment is ongoing.

Conclusions:

Existing research on partnered YMSM within the framework of Couples Interdependence Theory (CIT) has suggested that relationship factors (e.g., dyadic functioning and sexual agreements) are meaningfully related to substance use and HIV transmission risk for partnered men. Results pertaining to the efficacy of the proposed intervention, as well as the identification of putative moderators and mediators, will substantially inform the tailoring of interventions for YMSM in relationships and contribute to a growing body of relationship science focused on enhancing health outcomes. Clinical Trial: ClinicalTrials.gov; NCT03396367


 Citation

Please cite as:

Starks TJ, Robles G, Pawson M, Jimenez RH, Gandhi M, Parsons JT, Millar BM

Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol

JMIR Res Protoc 2019;8(7):e13015

DOI: 10.2196/13015

PMID: 31274114

PMCID: 6637725

Per the author's request the PDF is not available.