Evaluation of Haitian American Responsible Teens

NCT02674165 | Completed Phase 3

• 1 other identifier: H30298
• Study Type: interventional
• Target: 637
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Haitian American Responsible Teen (HART) afterschool program, a cultural adaptation of the BART curriculum, will provide an HIV/AIDS curriculum adapted to Haitian students that consists of eight sessions lasting approximately two hours each over a twelve- week period. The comparison group will receive a nutrition intervention during the same time period. The primary goals of the evaluation are to determine the effectiveness of the HART program on delaying initiation of sexual intercourse, reducing number of sexual partners, and increasing "abstinent" behavior and contraception use among those who were sexually experienced at baseline. Over a five semester period, the programs will be implemented in 7 or more schools in the greater Boston area, with offerings in the fall, the spring and summer, among approximately 780 male and female Haitian students. The programs will recruit 9th \& 10th grade Haitian students who will range in age from 13 to 19 years old. We will implement a randomized controlled trial in which each semester, students within schools will be stratified by gender and then randomly assigned to participate in the HART or the nutrition condition. Students will be recruited annually and enrolled until the summer of 2015. During the spring and summer of 2012, 120 youth will be randomly assigned to a treatment condition. During year three, 180 youth will be randomly assigned to condition each semester (360 youth total during Year 3). During year four, 180 youth will be randomly assigned in the first semester, and 120 youth will be randomly assigned in the second semester (300 youth total during Year 4). The number of times student-level randomization will occur and the number of groups formed will vary depending on the size of the 9th and 10th grade Haitian population served in each school.

Conditions

Sexual Behavior

Outcome Measures

Primary Outcomes (1)

• HIV knowledge measured by having a statistically significant difference between treatment and control participants, in proportion of true or false statements about HIV transmission, prevention and cure that are accurately identified.

  This outcome is collected at one week post intervention using a quantitative self-administered survey. Pre-test measures and key demographic data e.g. age, gender and other covariates of prognostic significance that are found not to have a balanced distribution between the treatment and control are adjusted for using multivariate analysis to increase precision of treatment effect measure

  One week after the intervention ended

Secondary Outcomes (3)

• Three- cognitive constructs that are causally related with HIV knowledge within the "Information Motivation and Behavioral Skills" framework.. Our study includes : 3 measures of Personal motivation

  One week after the intervention ended

• 4 measures of Social motivation for preventive behavior

  One week after the intervention ended

• 4 measures of Behavioral skills of avoiding risky social situations that could engage in risky sexual behavior.

  One week after the intervention ended

Study Arms (2)

Intervention

EXPERIMENTAL

The pregnancy prevention intervention to be tested is an adaptation of Becoming a Responsible Teen (BART), an evidence-based (proven to work by research) HIV prevention curriculum designed primarily for African American adolescents, ages 14-18, in community-based settings. The culturally-adapted version HART consists of nine sessions, lasting about 2 hours each, and includes interactive group discussions and role plays that are -performed by adolescents. Unlike BART, one PTSD awareness session has been added to address what happens to people who have been exposed to mental trauma and natural disasters.

Behavioral: HART

Control or nutrition

NO INTERVENTION

Nutrition/fitness curriculum will teach students about ingredients in food that are good for the body and will keep it in good health

Interventions

HART BEHAVIORAL

Skills based sexual education intervention plus PTSD awareness

Intervention

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Haitian descent
• to 19 years of age
• th and 10th grade
• Having signed assent and parental consent forms
• Willingness to participate in the pretest survey

You may not qualify if:

• Not of Haitian descent
• Age greater than 19 years
• Under 13 years of age
• Cognitive impairment
• Not having signed assent and parental consent forms
• Not willingness to participate in the pretest survey

Sponsors & Collaborators

• Boston Medical Center: lead

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professosr of Pediatrics

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 4, 2016
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share