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. 2024 Nov 19;24(1):3216.
doi: 10.1186/s12889-024-20719-y.

A protocol for a randomized controlled trial of couples motivational interviewing to reduce drug use and HIV transmission risk among male couples in the US: the Couples Health Project

Tyrel J Starks  1   2 , Joseph R Hillesheim  3 , Juan Castiblanco  3 , Gabriel Robles  4 , Karen S Ingersoll  5 , Angulique Y Outlaw  6 , Demetria Cain  3
Affiliations

A protocol for a randomized controlled trial of couples motivational interviewing to reduce drug use and HIV transmission risk among male couples in the US: the Couples Health Project

Tyrel J Starks et al. BMC Public Health. .

Abstract

Background: To reduce substance use and sexual HIV transmission risk among sexual minority men (SMM) requires the development of interventions tailored for those in relationships. In the past 5 years, there have been considerable advances in the development of motivational nterviewing (MI) with couples. The Couples Health Project (CHP) is the first multi-session risk reduction protocol built on this formative research. The purpose of this study is to evaluate the efficacy of CHP relative to a standard of care control - couples HIV testing and counseling (CHTC).

Methods: Eligibility includes couples where both partners are aged 18 or older, identify as cisgender male (assigned male sex at birth and identify as male gender), live in the US, and can communicate in English. Additionally, at least one partner has to be aged 18-34, HIV-negative, report recent drug use (excluding cannabis) and report condomless anal sex during the past 30 days. Couples are randomized post-baseline assessment to either CHP or CHTC. Follow-up assessments are completed at 3, 6, and 9-months post-randomization.

Discussion: Findings from this trial will inform the practice of MI with couples. If found efficacious, the CHP intervention would be the first multi-session MI with couples' risk reduction protocol designed for use by substance use treatment or HIV prevention service providers who wish to engage SMM and their relationship partners.

Protocol version: 1.0; April 1, 2024.

Trial registration: ClinicalTrials.gov Protocol Registration; NCT06307977; completed March 6, 2024; https://register.

Clinicaltrials: gov/ .

Keywords: Club drugs; Couples; Emerging adults; Gay and bisexual men; Men who have sex with men; Substance use.

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Conflict of interest statement

Declarations Ethics approval and consent to participate All procedures were reviewed by the CUNY University Integrated Institutional Review Board (CUNY-UI IRB). Participants will be provided consent information in writing. Consent information will be verbally reviewed by a research assistant and participants will verbally indicate consent to participate. A waiver of documentation of consent was obtained to reduce participant burden in this remote intervention study. Consent for publication Not applicable. Competing interests The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Participant timeline
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References

    1. Diagnoses of HIV infection in the United States and Dependent Areas. 2021 [https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-34/index.html]
    1. Davidovich U, de Wit J, Albrecht N, Geskus R, Stroebe W, Coutinho R. Increase in the share of steady partners as a source of HIV infection: a 17-year study of seroconversion among gay men. AIDS. 2001;15(10):1303–8. - PubMed
    1. Sullivan PS, Salazar L, Buchbinder S, Sanchez TH. Estimating the proportion of HIV transmissions from main sex partners among men who have sex with men in five US cities. AIDS. 2009;23(9):1153–62. - PubMed
    1. Goodreau SM, Carnegie NB, Vittinghoff E, Lama JR, Sanchez J, Grinsztejn B, Koblin BA, Mayer KH, Buchbinder SP. What drives the US and Peruvian HIV epidemics in men who have sex with men (MSM)? PLoS ONE. 2012;7(11):e50522. - PMC - PubMed
    1. Goodreau SM, Carnegie NB, Vittinghoff E, Lama JR, Sanchez J, Grinsztejn B, Koblin BA, Mayer KH, Buchbinder SP. Correction: what drives the US and Peruvian HIV epidemics in men who have sex with men (MSM)? PLoS ONE. 2013;8(7):e50522. - PMC - PubMed

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