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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854853
• Other study ID #: 6394
• Secondary ID: R34MH094163
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2013
• Last updated: October 11, 2016
• Start date: August 2012
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 24 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV
• Infection
• Pregnancy
• Sexually Transmitted Diseases
• Sexually Transmitted Infection

Intervention

Behavioral:
• STYLE Brazil
Multifamily group HIV/STI Prevention Intervention
• Health Promotion
Health promotion intervention

Locations

Country	Name	City	State
Brazil	CAPSi João Caetano	Itaborai	RJ

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. Epub 2007 Jan 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Parent-adolescent communication about sex scale	The measure assess parent adolescent communication about sex in the last 3 months	Past 3 months	No