Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health … (NCT01854853) | Clinical Trial Compass
CompletedPhase 1
Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health Disorder
Brazil305 participantsStarted 2012-08
Plain-language summary
Adolescents with mental health (MH) disorders (MHD) have higher rates of HIV/STI sexual risk behaviors than those in the general population. In Brazil, among youth seeking HIV testing, those testing positive had more MH problems than HIV-negative youth; HIV/STI sexual risk reduction is not regularly implemented within MH care for adolescents. Our NIMH-funded RCT in Rio de Janeiro (Rio; R01MH065163; PI: Wainberg) promises to provide such intervention for adults with MHD. A comparable evidence-based HIV/STI prevention intervention for adolescents is not available in Brazil; this application targets this need.
Using quantitative and qualitative methods we will explore the contextual influences on sexual risk behavior of Brazilian youth ages 13-24 with MHD to inform intervention adaptation. The investigators will then pilot-test the family-based (parent-adolescent dyad) intervention HIV, STI and pregnancy prevention intervention with a sample of male and female youth age 13-24 years (n=144) with MHD who are in MH treatment in four community-based sites in preparation for the RCT.
Who can participate
Age range
13 Years – 24 Years
Sex
ALL
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:
* Adolescent with a mental health disorder in any of the four pilot sites;
* Ages 13-24;
* having a caregiver who is willing to participate and sign consent for their adolescent's involvement in the study.
Exclusion Criteria:
* primary alcohol or other drug use disorder (AOD);
* mental retardation or pervasive developmental disorder as primary diagnosis;
* a medical or psychiatric illness requiring hospitalization; and
* currently psychotic or suicidal.
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.