Clinical trial NCT00494273: HIV Prevention in Haitian American Adolescents
Official title: HIV Prevention in Haitian Youths (HAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: Haitian American Adolescents
HIV Prevention
Cognitive Behavioral Intervention
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-06-29
Enrollment: 320
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

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
measure: Sexual and Condom Attitudes
measure: Self-Efficacy Scale
measure: Behavioral Intentions scale
measure: Health Protective Sexual Communication Scale
measure: Comfort talking about Safer Sex measure
measure: Condom Use Skills
measure: Risk Behavior Assessment
Secondary outcomes:
measure: Examples are
measure: The Millon Adolescent Clinical Inventory
measure: The Adolescent-Family Inventory of Life Events & Changes
measure: Stephenson Multigroup Acculturation Scale
measure: Adolescent Health Questionnaire-Adolescent and Parent Version.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Center for Haitian Studies
state: Florida
Study officials:
affiliation: Florida International University
name: Robert M. Malow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: