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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; HIV; Sexually Transmitted Infection
• Intervention / Treatment: Behavioral: STYLE Brazil; Behavioral: Health Promotion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Itaborai, RJ, Brazil
      • CAPSi João Caetano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: STYLE Brazil; STYLE-BRazil Multifamily Group HIV/STI Prevention intervention	Behavioral: STYLE Brazil; Multifamily group HIV/STI Prevention Intervention
ACTIVE_COMPARATOR: Health Promotion; Health Promotion Intervention - Adolescents only	Behavioral: Health Promotion; Health promotion intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AIDS Risk Behavior Assessment (ARBA)	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	In the past 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent-adolescent communication about sex scale	The measure assess parent adolescent communication about sex in the last 3 months	Past 3 months

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Milton L Wainberg, MD, NYSPI/Columbia University

Publications and helpful links

General Publications

• Wainberg ML, McKinnon K, Mattos PE, Pinto D, Mann CG, de Oliveira CS, de Oliveira SB, Remien RH, Elkington KS, Cournos F; PRISSMA Project. A model for adapting evidence-based behavioral interventions to a new culture: HIV prevention for psychiatric patients in Rio de Janeiro, Brazil. AIDS Behav. 2007 Nov;11(6):872-83. doi: 10.1007/s10461-006-9181-8. Epub 2007 Jan 10.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (ESTIMATE): May 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: HIV; Pregnancy; STI; safer sex; unsafe sex
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: 6394; R34MH094163 (NIH)