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HIV Prevention in Haitian American Adolescents

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral and Standard Care with Healthy Living

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Haitian American Adolescents, HIV Prevention, Cognitive Behavioral Intervention

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The adolescent reports being at high risk for HIV transmission by virtue of having ever engaged in risky sexual behavior.
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.).
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.
The adolescent is willing to assent for participation in the study.
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.
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).
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.
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.

Sites / Locations

Center for Haitian Studies

Outcomes

Primary Outcome Measures

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

Sexual and Condom Attitudes

Self-Efficacy Scale

Behavioral Intentions scale

Health Protective Sexual Communication Scale

Comfort talking about Safer Sex measure

Condom Use Skills

Risk Behavior Assessment

Secondary Outcome Measures

Examples are

The Millon Adolescent Clinical Inventory

The Adolescent-Family Inventory of Life Events & Changes

Stephenson Multigroup Acculturation Scale

Adolescent Health Questionnaire-Adolescent and Parent Version.

Full Information

NCT ID

NCT00494273

First Posted

June 28, 2007

Last Updated

October 28, 2014

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00494273

Brief Title

HIV Prevention in Haitian American Adolescents

Official Title

HIV Prevention in Haitian Youths (HAP)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Haitian American Adolescents, HIV Prevention, Cognitive Behavioral Intervention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

320 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral and Standard Care with Healthy Living

Primary Outcome Measure Information:

Title

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

Title

Sexual and Condom Attitudes

Title

Self-Efficacy Scale

Title

Behavioral Intentions scale

Title

Health Protective Sexual Communication Scale

Title

Comfort talking about Safer Sex measure

Title

Condom Use Skills

Title

Risk Behavior Assessment

Secondary Outcome Measure Information:

Title

Examples are

Title

The Millon Adolescent Clinical Inventory

Title

The Adolescent-Family Inventory of Life Events & Changes

Title

Stephenson Multigroup Acculturation Scale

Title

Adolescent Health Questionnaire-Adolescent and Parent Version.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The adolescent reports being at high risk for HIV transmission by virtue of having ever engaged in risky sexual behavior. 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.). 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. The adolescent is willing to assent for participation in the study. 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. 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). 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert M. Malow, Ph.D.

Organizational Affiliation

Florida International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Haitian Studies

City

Miami

State/Province

Florida

ZIP/Postal Code

33138

Country

United States

12. IPD Sharing Statement

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HIV Prevention in Haitian American Adolescents

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