Clinical Trials Directory

Trials / Completed

CompletedNCT00494273

HIV Prevention in Haitian American Adolescents

HIV Prevention in Haitian Youths (HAP)

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
320 (planned)
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
Sex
All
Age
14 Years – 17 Years
Healthy volunteers
Accepted

Summary

There has not been a great deal of research involving Haitian American adolescents and HIV risk reduction. The purpose of the study is to learn better ways to teach teenagers about living healthy by educating these children about how to make good choices about things like eating healthy, exercise, and sexual behavior. The primary focus of the proposed study is to understand the mechanisms of adopting safer sex practices among Haitian American (H-A) adolescents. We will enroll 160 male and 160 female participants to achieve the target sample of 272 participants at the 12-month follow-up time point.

Detailed description

The primary focus of the study is to understand the mechanisms of adopting safer sex practices among Haitian American (H-A) adolescents. We replicated a Cognitive-Behavioral HIV transmission risk reduction (CB-HIV-TRR) intervention entitled "Becoming A Responsible Teen" (BART, St. Lawrence, et al, 1995; St. Lawrence, 1998). This approach, which emphasizes building skills and self-efficacy in the process of risk reduction, was demonstrated to be highly effective with African American male and female adolescents in Mississippi. In a meta-analysis of published CB-HIV-RR intervention outcome studies (Kalichman, et al., 1996), the BART intervention was shown to have produced the highest effect not only for the published studies with adolescents, but also for HIV prevention interventions of all other populations studied. Based on its promising effects, the BART intervention has been officially designed as one of only four HIV risk "Programs that Work" by CDC Division of Adolescent and School Health (DASH). CDC designates programs as such based on reviewing programs in the literature using rigorous criteria. The proposed work focused on delineating theoretically important conditions associated with HIV transmission risk reduction (HIV-TRR) to address issues of mechanism of action and generalizability, respectively. Specifically, this 5 year study evaluates the effects of a version of the BART intervention that has been adapted to be appropriate to Haitian adolescents in Miami) as compared to a standard care (SC) condition among 160 male and 160 female high risk Haitian adolescents.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral and Standard Care with Healthy Living

Timeline

Start date
2002-12-01
Primary completion
2006-12-01
Completion
2006-12-01
First posted
2007-06-29
Last updated
2014-10-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00494273. Inclusion in this directory is not an endorsement.