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Completed

NCT Number: NCT01854853

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

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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Key information

Age range

13 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CAPSi João Caetano

Itaboraí, Rio de Janeiro, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STYLE Brazil

Behavioral

Multifamily group HIV/STI Prevention Intervention

health promotion

Behavioral

Health promotion intervention

Primary outcomes

  1. AIDS Risk Behavior Assessment (ARBA)

    Time frame: In the past 3 months

    We will assess sexual activity, unprotected sex acts and number of sexual partners (if sexually active) or delay sexual debut (if not sexually active) in the last 3 months at baseline and 3 months post intervention

Secondary outcomes

  1. Parent-adolescent communication about sex scale

    Time frame: Past 3 months

    The measure assess parent adolescent communication about sex in the last 3 months

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 16, 2013
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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