Evaluation of Haitian American Responsible Teens

NCT ID: NCT02674165

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 637 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-09-30

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.

Detailed Description

This is an intervention with an evaluation component. In each school, students will have equal chance to participate in the sex education class or in the nutrition education class. Each participating school will have two (2) groups:

• The intervention group which will receive the HART sex education curriculum.
• The comparison group which will receive a nutrition education curriculum. There will be one PTSD awareness session for both groups.. This session will be provided by mental health professionals from the Haitian Mental Health Network. Each group will consist of about 13-15 student participants, with the groups meeting each week on specific week days. In addition to the ten-week curriculum, there will be sessions at the beginning and end of the cycle to administer the pre- and post-test questionnaires. The 12-week cycle will be repeated 2-3 times through the school year.

Conditions

Sexual Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

HART

Intervention Type: BEHAVIORAL

Skills based sexual education intervention plus PTSD awareness

Control or nutrition

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HART

Skills based sexual education intervention plus PTSD awareness

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Haitian descent

2. 13 to 19 years of age

3. 9th and 10th grade

4. Having signed assent and parental consent forms

5. Willingness to participate in the pretest survey

Exclusion Criteria

1. Not of Haitian descent

2. Age greater than 19 years

3. Under 13 years of age

4. Cognitive impairment

5. Not having signed assent and parental consent forms

6. Not willingness to participate in the pretest survey

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nicole Prudent

Associate Clinical Professosr of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

H30298

Identifier Type: -

Identifier Source: org_study_id