Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men.

BACKGROUND: Gay, bisexual, and other men who have sex with men (GBMSM) represent a high-risk group for HIV transmission in Romania, yet they possess few resources for prevention. Despite having no formal access to pre-exposure prophylaxis (PrEP) through the health system, GBMSM in Romania demonstrate a high need for and interest in this medication. In anticipation of a national rollout of PrEP, this study tests the efficacy of a novel strategy, Prepare Romania, that combines two evidence-based PrEP promotion interventions for GBMSM living in Romania. METHODS: This study uses a randomized controlled trial design to examine whether GBMSM living in Romania receiving Prepare Romania, a culturally adapted counseling and mobile health intervention (expected n = 60), demonstrate greater PrEP adherence and persistence than those assigned to a PrEP education control arm (expected n = 60). Participants from two main cities in Romania are prescribed PrEP and followed-up at 3 and 6 months post-randomization. PrEP adherence data are obtained through weekly self-report surveys and dried blood spot testing at follow-up visits. Potential mediators (e.g., PrEP use motivation) of intervention efficacy are also assessed. Furthermore, Prepare Romania's implementation (e.g., proportion of enrolled participants attending medical visits, intervention experience) will be examined through interviews with participants, study implementers, and healthcare officials. DISCUSSION: The knowledge gained from this study will be utilized for further refinement and scale-up of Prepare Romania for a future multi-city effectiveness trial. By studying the efficacy of tools to support PrEP adherence and persistence, this research has the potential to lay the groundwork for PrEP rollout in Romania and similar contexts. Trial registration This study was registered on ClinicalTrials.gov, identifier NCT05323123 , on March 25, 2022.

An mHealth Intervention for Gay and Bisexual Men's Mental, Behavioral, and Sexual Health in a High-Stigma, Low-Resource Context (Project Comunica): Protocol for a Randomized Controlled Trial.

BACKGROUND: The World Health Organization reported that 80% of new HIV diagnoses in Europe in 2014 occurred in Central and Eastern Europe. Romania has a particularly high HIV incidence, AIDS prevalence, and number of related deaths. HIV incidence in Romania is largely attributed to sexual contact among gay and bisexual men. However, homophobic stigma in Romania serves as a risk factor for HIV infection for gay and bisexual men. The Comunica intervention aims to provide a much-needed HIV risk reduction strategy, and it entails the delivery of motivational interviewing and cognitive behavioral therapy skills across 8 live text-based counseling sessions on a mobile platform to gay and bisexual men at risk of HIV. The intervention is based on the information-motivation-behavior and minority stress models. There is preliminary evidence suggesting that Comunica holds promise for reducing gay and bisexual men's co-occurring sexual (eg, HIV transmission risk behavior), behavioral (eg, heavy alcohol use), and mental (eg, depression) health risks in Romania. OBJECTIVE: This paper describes the protocol for a randomized controlled trial designed to test the efficacy of Comunica in a national trial. METHODS: To test Comunica's efficacy, 305 gay and bisexual men were randomized to receive Comunica or a content-matched education attention control condition. The control condition consisted of 8 time-matched educational modules that present information regarding gay and bisexual men's identity development, information about HIV transmission and prevention, the importance of HIV and sexually transmitted infection testing and treatment, heavy alcohol use and its associations with HIV transmission risk behavior, sexual health communication, finding social support, and creating sexual health goals. Participants undergo rapid HIV and syphilis testing and 3-site chlamydia and gonorrhea testing at baseline and the 12-month follow-up. Outcomes are measured before the intervention (baseline) and at the 4-, 8-, and 12-month follow-ups. RESULTS: The study was funded in September 2018, and data collection began in May 2019. The last participant follow-up was in January 2024. Currently, the data analyst is cleaning data sets in preparation for data analyses, which are scheduled to begin in April 2024. Data analysis meetings are scheduled regularly to establish timelines and examine the results as analyses are gradually being conducted. Upon completion, a list of manuscripts will be reviewed and prioritized, and the team will begin preparing them for publication. CONCLUSIONS: This study is the first to test the efficacy of an intervention with the potential to simultaneously support the sexual, behavioral, and mental health of gay and bisexual men in Central and Eastern Europe using motivational interviewing support and sensitivity to the high-stigma context of the region. If efficacious, Comunica presents a scalable platform to provide support to gay and bisexual men living in Romania and similar high-stigma, low-resource countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT03912753; https://clinicaltrials.gov/study/NCT03912753. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52853.

A randomized controlled trial of an mHealth intervention for gay and bisexual men's mental, behavioral, and sexual health in a high-stigma, low-resource context: Project Comunica protocol.

Background: The World Health Organization (WHO) reported that 80% of new HIV diagnoses in 2014 in Europe occurred in Central and Eastern Europe (CEE). Romania has particularly high HIV incidence, AIDS prevalence, and AIDS-related deaths. HIV incidence today in Romania is largely attributed to sexual contact among gay and bisexual men (GBM). However, homophobic stigma in Romania keeps GBM out of reach of the scant available prevention services and serves as a risk factor for HIV. The Comunica intervention delivers motivational interviewing and cognitive-behavioral therapy skills across eight live text-based counseling sessions. Preliminary evidence suggests that Comunica possesses promise for reducing GBM's co-occurring mental (e.g., depression), behavioral (e.g., heavy alcohol use), and sexual (e.g., HIV-transmission-risk behavior) health risks in Romania and perhaps other similar high-stigma national contexts. This paper describes a randomized controlled trial (RCT) designed to test the efficacy of Comunica. Methods: To test Comunica's efficacy, 305 GBM were randomized to receive Comunica or a content-matched education attention control condition. The control condition consists of eight time-matched educational modules that present information regarding GBM identity development, information about HIV transmission and prevention, the importance of HIV/STI testing and treatment, heavy alcohol use and its associations with HIV-transmission-risk behavior, sexual health communication, finding social support, and creating sexual health goals. Outcomes are measured pre-intervention (baseline), and at 4-, 8-, and 12-month follow-ups. The primary outcome is frequency of condomless anal sex acts with HIV-positive or unknown-status partners outside of the context of one's own adherent PrEP use or primary partner's adherent PrEP use or undetectable viral load in the past 30 days at each follow-up. Secondary outcomes include depression, anxiety, suicidal thoughts, heavy alcohol use, and HIV/STI testing; motivational and stigma-related mechanisms of intervention efficacy will also be examined. Discussion: If found to be efficacious, Comunica presents a scalable platform to provide mental, behavioral, and sexual health support to GBM living in Romania and similar high-stigma, low-resource areas within the CEE region and beyond. Trial registration: Registered April 11, 2019 to ClinicalTrials.gov Identifier: NCT03912753.