Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health Disorder
Primary Purpose
HIV, Sexually Transmitted Infection, Pregnancy
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
STYLE Brazil
Health Promotion
Sponsored by
About this trial
This is an interventional prevention trial for HIV focused on measuring unsafe sex, safer sex, HIV, STI, Pregnancy
Eligibility 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.
Sites / Locations
- CAPSi João Caetano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STYLE Brazil
Health Promotion
Arm Description
STYLE-BRazil Multifamily Group HIV/STI Prevention intervention
Health Promotion Intervention - Adolescents only
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Parent-adolescent communication about sex scale
The measure assess parent adolescent communication about sex in the last 3 months
Full Information
NCT ID
NCT01854853
First Posted
May 2, 2013
Last Updated
October 11, 2016
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01854853
Brief Title
Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health Disorder
Official Title
Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Infection, Pregnancy
Keywords
unsafe sex, safer sex, HIV, STI, Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
305 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STYLE Brazil
Arm Type
Experimental
Arm Description
STYLE-BRazil Multifamily Group HIV/STI Prevention intervention
Arm Title
Health Promotion
Arm Type
Active Comparator
Arm Description
Health Promotion Intervention - Adolescents only
Intervention Type
Behavioral
Intervention Name(s)
STYLE Brazil
Intervention Description
Multifamily group HIV/STI Prevention Intervention
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion
Intervention Description
Health promotion intervention
Primary Outcome Measure Information:
Title
AIDS Risk Behavior Assessment (ARBA)
Description
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
Time Frame
In the past 3 months
Secondary Outcome Measure Information:
Title
Parent-adolescent communication about sex scale
Description
The measure assess parent adolescent communication about sex in the last 3 months
Time Frame
Past 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton L Wainberg, MD
Organizational Affiliation
NYSPI/Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAPSi João Caetano
City
Itaborai
State/Province
RJ
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
17216334
Citation
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.
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Brazilian HIV/Sexually Transmitted Infection (STI) Prevention for Adolescents With Mental Health Disorder
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