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

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ClinicalTrials.gov Identifier: NCT01854853
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:

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 or disease Intervention/treatment Phase
HIV Sexually Transmitted Infection Pregnancy Behavioral: STYLE Brazil Behavioral: Health Promotion Phase 1

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  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health
Study Start Date : August 2012
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854853


Locations
Brazil
CAPSi João Caetano
Itaborai, RJ, Brazil
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Milton L Wainberg, MD NYSPI/Columbia University

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01854853     History of Changes
Other Study ID Numbers: 6394
R34MH094163 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

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

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