HIV Prevention in Haitian American Adolescents

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Behavioral: Cognitive Behavioral and Standard Care with Healthy Living	Phase 1; Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	320 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single
Primary Purpose:	Prevention
Official Title:	HIV Prevention in Haitian Youths (HAP)
Study Start Date :	December 2002
Actual Primary Completion Date :	December 2006
Actual Study Completion Date :	December 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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
2. Sexual and Condom Attitudes
3. Self-Efficacy Scale
4. Behavioral Intentions scale
5. Health Protective Sexual Communication Scale
6. Comfort talking about Safer Sex measure
7. Condom Use Skills
8. Risk Behavior Assessment

Secondary Outcome Measures :

1. Examples are
2. The Millon Adolescent Clinical Inventory
3. The Adolescent-Family Inventory of Life Events & Changes
4. Stephenson Multigroup Acculturation Scale
5. Adolescent Health Questionnaire-Adolescent and Parent Version.

Eligibility Criteria

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Ages Eligible for Study:	14 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Locations

United States, Florida
Center for Haitian Studies
Miami, Florida, United States, 33138

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:	Robert M. Malow, Ph.D.	Florida International University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00494273 History of Changes
Other Study ID Numbers:	R01HD038458 ( U.S. NIH Grant/Contract )
First Posted:	June 29, 2007
Last Update Posted:	October 29, 2014
Last Verified:	September 2014

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Haitian American Adolescents; HIV Prevention; Cognitive Behavioral Intervention

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases	Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases