NCT01854853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for phase_1 hiv

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1 hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

May 2, 2013

Last Update Submit

October 11, 2016

Conditions

HIVSexually Transmitted InfectionPregnancy

Keywords

unsafe sexsafer sexHIVSTIPregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Parent-adolescent communication about sex scale

    Past 3 months

Study Arms (2)

STYLE Brazil

EXPERIMENTAL

STYLE-BRazil Multifamily Group HIV/STI Prevention intervention

Behavioral: STYLE Brazil

Health Promotion

ACTIVE COMPARATOR

Health Promotion Intervention - Adolescents only

Behavioral: Health Promotion

Interventions

STYLE BrazilBEHAVIORAL

Multifamily group HIV/STI Prevention Intervention

STYLE Brazil
Health PromotionBEHAVIORAL

Health promotion intervention

Health Promotion

Eligibility Criteria

Age13 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CAPSi João Caetano

Itaboraí, Rio de Janeiro, Brazil

Location

Related 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. doi: 10.1007/s10461-006-9181-8. Epub 2007 Jan 10.

    PMID: 17216334BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted DiseasesUnsafe Sex

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Milton L Wainberg, MD

    NYSPI/Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 16, 2013

Study Start

August 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

BR(1)