CompletedNot Applicable

Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)

United States34 participantsStarted 2021-09-30

Plain-language summary

The primary goal of this study is to test a minority stress model of psychological health outcomes for Black sexual minority men (BSMM) while using and not using a novel intervention named THRIVE 365. THRIVE 365 combines mHealth and institutional support elements to provide four areas of support for BSMM: 1) Promote HIV and psychological health knowledge and motivation; 2) Foster a sense of community and positive social connections among BSMM; 3) Connect clients to BSMM-affirming healthcare, including HIV treatment and mental healthcare; 4) Provide resources for housing, transportation, and other economic empowerment. To examine the effects of the intervention, we will utilize a 14-day daily diary study to capture daily intervention engagement, HIV and psychological health outcomes, coping, and experiences of racial and sexual minority stressors. We will first examine main associations between intervention engagement and HIV (antiretroviral treatment use) and psychological health (depressive symptoms, anxiety symptoms, emotion regulation difficulties outcomes) outcomes, then consider how intervention engagement affects coping and attenuates the impacts of racial and sexual minority stressors during the 14 day period.

Who can participate

Age range

16 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 16 years old or older ; * Identifying as masculine * Identifying as Black/African American * Reporting being attracted to and/or sexually active with men; * Able to complete all procedures in English. * Mobile access to the internet in order to complete the once-daily survey procedures. Exclusion Criteria: * evidence of unstable, unmanaged, or serious psychiatric symptoms that could be made worse by participation; * evidence of gross cognitive impairment that would interfere with successful completion of study procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Antiretroviral (ART) Medication Use

Timeframe: 24 Hours

Depressive Symptoms

Timeframe: 24 Hours

Anxiety Symptoms

Timeframe: 24 Hours

Emotion Regulation

Timeframe: 24 Hours

Trial details

NCT IDNCT05376397

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-30

Results submitted2023-12-18

View on ClinicalTrials.gov More Medication Adherence trials

Plain-language summary

Who can participate

Age range

16 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.