An mHealth Intervention for Gay and Bisexual Men’s Health in Romania: Clinical Trial Protocol
Background
The Comunică intervention aims to reduce HIV risk among gay and bisexual men in Romania, where stigma contributes to high HIV incidence. It involves live text-based counseling sessions using motivational interviewing and cognitive behavioral therapy skills.
Objective
This paper describes the protocol for a randomized controlled trial to test the efficacy of Comunică in a national trial.
Methods
305 gay and bisexual men were randomized to receive Comunică or a content-matched education attention control condition. Participants undergo rapid HIV and syphilis testing and 3-site chlamydia and gonorrhea testing at baseline and the 12-month follow-up.
Results
Data collection began in May 2019, and data analyses are scheduled to begin in April 2024. The study aims to prioritize and publish a list of manuscripts upon completion.
Conclusions
If efficacious, Comunică presents a scalable platform to support gay and bisexual men living in Romania and similar high-stigma, low-resource countries.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03912753; Link
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