Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings (NCT03912753) | Clinical Trial Compass
CompletedNot Applicable
Building Mobile HIV Prevention and Mental Health Support in Low-resource Settings
Romania300 participantsStarted 2019-05-20
Plain-language summary
The purpose of this research study is to provide help and support for mental health and human immunodeficiency virus (HIV) risk reduction among Romanian gay and bisexual men.
GBM will participate in this study using mobile device (phones, tablets, or laptops) and will complete several confidential surveys and 8 confidential one-hour sessions, either with a trained counselor via chat or by reading about health information. This study also involves testing for HIV, syphilis, chlamydia, and gonorrhea.
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:
Gay and bisexual men (GMB) will be eligible if they report:
* Male sex at birth and current male identity;
* At least 16 years old;
* ≥ 1 act of condomless anal sex with an HIV-positive or status-unknown male partner in the prior month;
* ≥ 2 heavy drinking days in the prior month;
* Own a mobile device (smartphone, tablet, laptop); and
* Are confirmed to be HIV-negative upon testing at study baseline.
Exclusion Criteria:
* GMB will be excluded if they report past-year: a) psychiatric hospitalization; b) psychotic and manic symptoms; or c) current mood-stabilizing or anti-psychotic medication prescription
* Any condition that, in the principal investigators' judgment, interferes with safe study participation.
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
1
Number of Self-reported Condomless Anal Sex (CAS) Acts in the Last 30 Days
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline
2
Number of Self-reported Days With Heavy Alcohol Use in the Last 30 Days
Timeframe: Measured at baseline, 4 months post-baseline, 8 months post-baseline, and 12 months post-baseline