Viewing Study NCT00494273



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Last Modification Date: 2024-10-26 @ 9:34 AM
Study NCT ID: NCT00494273
Status: COMPLETED
Last Update Posted: 2014-10-29
First Post: 2007-06-28

Brief Title: HIV Prevention in Haitian American Adolescents
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD

Study Overview

Official Title: HIV Prevention in Haitian Youths HAP
Status: COMPLETED
Status Verified Date: 2014-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None