Clinical trial NCT02674165: Evaluation of Haitian American Responsible Teens
Official title: Evaluation of Haitian American Responsible Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Behavior
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 637
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: One week after the intervention ended
Secondary outcomes:
measure: 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
timeFrame: One week after the intervention ended
measure: 4 measures of Social motivation for preventive behavior
timeFrame: One week after the intervention ended
measure: 4 measures of Behavioral skills of avoiding risky social situations that could engage in risky sexual behavior.
timeFrame: One week after the intervention ended
Other outcomes:
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