Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Sexually Transmitted Infection Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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STYLE Brazil

STYLE-BRazil Multifamily Group HIV/STI Prevention intervention

Group Type EXPERIMENTAL

STYLE Brazil

Intervention Type BEHAVIORAL

Multifamily group HIV/STI Prevention Intervention

Health Promotion

Health Promotion Intervention - Adolescents only

Group Type ACTIVE_COMPARATOR

Health Promotion

Intervention Type BEHAVIORAL

Health promotion intervention

Interventions

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STYLE Brazil

Multifamily group HIV/STI Prevention Intervention

Intervention Type BEHAVIORAL

Health Promotion

Health promotion intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No