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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive 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.