Overview

This trial is active, not recruiting.

Condition hiv infections
Treatment cognitive behavioral and standard care with healthy living
Phase phase 1/phase 2
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date December 2002
End date December 2006
Trial size 320 participants
Trial identifier NCT00494273, RO1HD38458

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose prevention

Primary Outcomes

Measure
The BART Condition will reduce HIV transmission risk behavior over time more than the SC. Assessments will be completed prior, after, 4 , 8 and 12 months after the intervention. Measure examples are
time frame:
Sexual and Condom Attitudes
time frame:
Self-Efficacy Scale
time frame:
Behavioral Intentions scale
time frame:
Health Protective Sexual Communication Scale
time frame:
Comfort talking about Safer Sex measure
time frame:
Condom Use Skills
time frame:
Risk Behavior Assessment
time frame:

Secondary Outcomes

Measure
Examples are
time frame:
The Millon Adolescent Clinical Inventory
time frame:
The Adolescent-Family Inventory of Life Events & Changes
time frame:
Stephenson Multigroup Acculturation Scale
time frame:
Adolescent Health Questionnaire-Adolescent and Parent Version.
time frame:

Eligibility Criteria

Male or female participants from 14 years up to 17 years old.

Inclusion Criteria: 1. The adolescent reports being at high risk for HIV transmission by virtue of having ever engaged in risky sexual behavior. 2. The adolescent is available for the full duration of the study with no anticipated circumstances impeding study participation (e.g., jail term, out-of-town, etc.). 3. The adolescent is fluent in spoken English required to complete our assessment battery and participate in group interventions. Because all of the adolescent are in or have been in the English speaking Public School system they virtually all are fluent in English. 4. The adolescent is willing to assent for participation in the study. 5. The adolescent has an identifiable parent or parent-figure (i.e., a number of adolescents will have sisters, aunts, or grandmothers who function as their primary caretaker) who is the legal guardian for the adolescent and who is willing to sign the informed consent. A bilingual assessor who is fluent in Creole will be available to parents that speak limited English and the consent forms for the parents will be in Creole. 6. The adolescent is assessed not to be harmful to self or others using the relevant sections of the POSIT-HRS and Millon Adolescent Clinical Inventory (MACI). 7. The adolescent has no evidence of psychiatric impairments (e.g., psychosis) that might compromise the participants’ ability to comprehend and participate in the assessment and intervention processes. 8. The child’s guardian will be invited to complete a questionnaire regarding communication with their teenager about sex and their guardian's level of acculturation.

Additional Information

Official title HIV Prevention in Haitian Youths (HAP)
Principal investigator Robert M. Malow, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2007.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).