HIV Clinical Trial
Official title:
Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health
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.
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. To address this public health need and opportunity, we propose to a) adapt a U.S. efficacious family-based HIV prevention intervention for youth with MHD (STYLE; R01MH63008; PI: Brown) within the three types of settings providing most of the care to adolescents with MHD in Brazil; and b) pilot test the intervention to examine the acceptability, feasibility, and implementation parameters of the resulting Brazil intervention (STYLE-B) within these settings, and to determine key research parameters in preparation for an implementation randomized clinical trial (RCT). 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 STYLE-B 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. Youth/caregiver dyads will receive a full-day group session, return in two weeks for an adolescent/caregiver dyad session, and participate in a half-day group session three months later. Acceptability and feasibility will be assessed using process measures after each session. The investigators will assess change in sexual risk behavior outcomes from baseline to 3-months post-intervention. The investigators will elucidate factors influencing intervention adoption (e.g., recruitment, referrals; resources; climate, readiness and capacity for intervention) within the three service systems for youth with MHD in Brazil. The investigators will develop digital web-based interactive technology to train intervention facilitators in preparation for the RCT. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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