Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa

Conditions
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Sexual Behavior, Intimate Partner Violence

Intervention / Treatment
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* Behavioral: Safe South Africa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male adolescent 15-17 years of age, inclusive of 15 and 17 Exclusion Criteria: parent/guardian does not provide consent adolescent does not provide assent

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Safe South Africa<br>* Core components of the Safe South Africa intervention include the following: Theory driven, best-evidence intervention approaches to adolescent HIV prevention Linkages between HIV and IPV Victim Empathy Healthy Norms Regarding Masculinity Bystander Intervention Skills<br>|
| No Intervention: Control<br>Male adolescents (15-17 years) will be randomly allocated to a control arm based on permuted blocked randomization. The control arm will consist of ordinary usual care. The ordinary usual care condition will consist of a packet of existing available brochures on HIV and other sexually transmitted diseases including testing, prevention, and treatment; IPV prevention and intervention; and places to access prevention, care, and support for these outcomes and related health outcomes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention acceptability | satisfaction with intervention content using a Client Satisfaction Questionnaire that measures satisfaction using likert scale responses | 6 months | 
| Intervention feasibility | Measured by attendance rates at intervention sessions | 6 months | 
| Intervention fidelity | Measured by coding % of the time interventionists have fidelity to core intervention components | at each intervention session, coding will be conducted through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sexual behavior | measured through rates of sexual risk behavior | 6 months | 
| Change from baseline in Intimate Partner Violence (IPV) behavior | measured through rates of IPV | 6 months | 
| Change from baseline in bystander intervention behavior | measured through rates of bystander intervention behavior | 6 months |