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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01854853
First received: May 2, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
HIV
Sexually Transmitted Infection
Pregnancy
Behavioral: Family-based intervention
Behavioral: Health Intervention (Placebo arm)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • AIDS Risk Behavior Assessment (ARBA) [ Time Frame: In the past 3 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Parent-adolescent communication about sex scale [ Time Frame: Past 3 months ] [ Designated as safety issue: No ]
    The measure assess parent adolescent communication about sex in the last 3 months


Estimated Enrollment: 600
Study Start Date: August 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family-based group intervention
Multifamily group of parent-adolescent dyads
Behavioral: Family-based intervention
multifamily group parent-adolescent dyads
Behavioral: Health Intervention (Placebo arm)
Health Intervention addressing multiple health issues - smocking, sexual transmitted infections, nutrition, etc.
Placebo Comparator: Health intervention
adolescent group intervention
Behavioral: Family-based intervention
multifamily group parent-adolescent dyads
Behavioral: Health Intervention (Placebo arm)
Health Intervention addressing multiple health issues - smocking, sexual transmitted infections, nutrition, etc.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854853

Locations
Brazil
CAPSi João Caetano Recruiting
Itaborai, RJ, Brazil
Contact: Priscila Ribeiro, Psychologist    55 21 2542.4517    psicologia_priscila@hotmail.com   
Principal Investigator: Katia Edmundo, PhD         
Sub-Investigator: Maria Tavares, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Milton L Wainberg, MD NYSPI/Columbia University
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01854853     History of Changes
Other Study ID Numbers: #6394/R34MH094163
Study First Received: May 2, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board
Brazil: Ethics Committee

Keywords provided by New York State Psychiatric Institute:
unsafe sex
safer sex
HIV
STI
Pregnancy

Additional relevant MeSH terms:
Mental Disorders
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014