Clinical trial NCT01854853: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV
Sexually Transmitted Infection
Pregnancy
Keywords: unsafe sex
safer sex
HIV
STI
Pregnancy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-05-16
Enrollment: 305
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: AIDS Risk Behavior Assessment (ARBA)
timeFrame: In the past 3 months
Secondary outcomes:
measure: Parent-adolescent communication about sex scale
timeFrame: Past 3 months
Other outcomes:
Locations:
city: Itaborai
country: Brazil
facility: CAPSi João Caetano
state: RJ
Study officials:
affiliation: NYSPI/Columbia University
name: Milton L Wainberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.