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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Behavior; Intimate Partner Violence
• Intervention / Treatment: Behavioral: Safe South Africa

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • South African Medical Research School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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
No Intervention: Control; 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?

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Rhode Island Hospital; Medical Research Council, South Africa

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): October 23, 2019
• Study Completion (Actual): October 23, 2019

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: R34MH113484 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No