Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa
- Conditions
- Intimate Partner ViolenceSexual Behavior
- Interventions
- Behavioral: Safe South Africa
- Registration Number
- NCT03179982
- Lead Sponsor
- Brown University
- Brief Summary
The purpose of this study is to test the feasibility and acceptability of Safe South Africa, an integrated intervention for preventing HIV and Intimate Partner Violence perpetration for male adolescents 15-17 years of age.
- Detailed Description
This study will investigate the acceptability and feasibility of Safe South Africa, an integrated intervention to prevent adolescent behavioral risk for human immunodeficiency virus (HIV) and perpetration of intimate partner violence (IPV). Safe South Africa is a theory-driven, developmentally-tailored and gender-specific intervention designed for male adolescents 15-17 years of age. The research will be conducted in South Africa, a country with the largest HIV epidemic and some of the highest rates of IPV perpetration in the world. Preventive interventions are urgently needed during adolescence when risk for human immunodeficiency virus (HIV) and intimate partner violence (IPV) increases exponentially. Yet, few behavioral interventions integrate HIV-IPV prevention and are tailored for the unique age and developmental needs of adolescents. We will investigate the acceptability and feasibility of Safe South Africa with three study aims: (1) a development aim - this aim will result in the creation of Safe South Africa, an integrated male adolescent preventive intervention for HIV risk behavior and IPV perpetration; (2) an acceptability aim - this aim will consist of an evaluation of the social ecology of HIV and IPV risk with a survey of N=100 of adolescents, and a test of the acceptability of Safe South Africa through an open pilot trial with N=20 male adolescents; and (3) a feasibility aim - this aim will consist of a randomized controlled pilot trial with 1- and 6-month follow-up in a sample of N=60 male adolescents to assess the feasibility and acceptability for a future fully powered randomized controlled trial to evaluate efficacy of the intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
- Male adolescent
- 15-17 years of age, inclusive of 15 and 17
- parent/guardian does not provide consent
- adolescent does not provide assent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Safe South Africa Male adolescents (15-17 years) will be randomly allocated to an intervention arm based on permuted blocked randomization. The intervention arm will receive the HIV-IPV intervention called Safe South Africa. Safe South Africa is a group-based, facilitated behavioral intervention for prevention of HIV risk and IPV perpetration specifically tailored for male adolescents. The behavioral intervention is comprised of 2-hour sessions, held once a week for a total of two weeks.
- Primary Outcome Measures
Name Time Method Intervention acceptability 6 months satisfaction with intervention content using a Client Satisfaction Questionnaire that measures satisfaction using likert scale responses
Intervention feasibility 6 months Measured by attendance rates at intervention sessions
Intervention fidelity at each intervention session, coding will be conducted through study completion, an average of 2 years Measured by coding % of the time interventionists have fidelity to core intervention components
- Secondary Outcome Measures
Name Time Method Change from baseline in sexual behavior 6 months measured through rates of sexual risk behavior
Change from baseline in Intimate Partner Violence (IPV) behavior 6 months measured through rates of IPV
Change from baseline in bystander intervention behavior 6 months measured through rates of bystander intervention behavior
Trial Locations
- Locations (1)
South African Medical Research School
🇿🇦Cape Town, South Africa