Testing the Efficacy of Safe South Africa

NCT ID: NCT06750107

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 836 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-22
• Study Completion Date: 2028-12-30

Brief Summary

In this study, investigators will examine the efficacy of Safe South Africa, a behavioral intervention that is developmentally- and gender-tailored to prevent human immunodeficiency virus (HIV) and intimate partner violence (IPV) among adolescent boys. South Africa faces some of the highest global rates of HIV and IPV with sustained high incidence of HIV and alarming rates of IPV among adolescents and thus, is an ideal site to advance prevention science to tackle these urgent public health priorities. Testing the efficacy of an integrated intervention to prevent HIV risk behavior and IPV for adolescent boys can support optimal health for young people, their future partners, and society.

Detailed Description

Adolescence presents an ideal developmental transition period for an integrated intervention targeting prevention of HIV risk behaviors and intimate partner violence (IPV), including sexual violence. Adolescent boys in particular are at high risk for HIV and perpetration of IPV. Yet, few behavioral interventions integrate HIV-IPV prevention and are tailored for the unique developmental needs of adolescent boys. In this study, investigators build on previous scientific work that demonstrated the acceptability and feasibility of Safe South Africa, an integrated HIV-IPV intervention that uses a developmentally- and gender-tailored approach grounded in social norms theory to prevent adolescent HIV risk behavior and IPV. Investigators will conduct the work in South Africa, a country with the largest HIV epidemic and some of the highest rates of IPV in the world. The investigative team propose the following specific aims: (1) Tailoring Safe South Africa intervention content to address the unique behavioral and social norms data that drives HIV and IPV behaviors among boys in their socioecological environments. (2) Testing the efficacy of the Safe South Africa intervention in preventing HIV/STIs and reducing IPV frequency among N=836 adolescent boys (ages 15- 17), with the scientific team's working hypothesis that the intervention, relative to the usual care condition, will show (a) lower incidence of any STI (including HIV); and (b) reductions in IPV perpetration frequency and decreased endorsement of IPV supportive attitudes. (3) Identifying barriers and facilitators to implementing Safe South Africa within a school setting to provide data for future dissemination (presuming Safe South Africa is efficacious). Investigators will examine processes critical to future dissemination through (a) fidelity data examining adherence to core active components of the standardized intervention manual guiding consistent delivery of the intervention; and (b) qualitative data on the experience during and post-implementation from adolescents and stakeholders using N=20 in-depth interviews with each group.

Conditions

Intervention; Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Behavioral Intervention Safe South Africa

This experimental behavioral intervention is designed to (a) lower incidence of sexually transmitted infections (gonorrhea, chlamydia and HIV); and (b) reductions in Intimate Partner Violence (IPV) perpetration frequency and decreased endorsement of IPV supportive attitudes

Group Type: EXPERIMENTAL

Safe South Africa

Intervention Type: BEHAVIORAL

The Safe South Africa intervention is a developmentally-tailored intervention for adolescent boys, designed to reduce actual or intended HIV risk behaviors, actual or intended IPV perpetration frequency, and endorsement of IPV supportive attitudes. This intervention comprises 2-hour sessions, held once a week for a total of two weeks. The intervention also includes take-home activities to deepen behavioral engagement with received sessions and to "prime the pump" for up-coming sessions. Part 2 involves behavioral practice, including bystander intervention techniques.

Control of Standard Care

The control arm will receive standard care. In South Africa, at the time of study planning there are no integrated HIV-IPV interventions that are evidence-based for this age group so the control group will not receive anything, reflective of what would be standard care in this setting.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Safe South Africa

The Safe South Africa intervention is a developmentally-tailored intervention for adolescent boys, designed to reduce actual or intended HIV risk behaviors, actual or intended IPV perpetration frequency, and endorsement of IPV supportive attitudes. This intervention comprises 2-hour sessions, held once a week for a total of two weeks. The intervention also includes take-home activities to deepen behavioral engagement with received sessions and to "prime the pump" for up-coming sessions. Part 2 involves behavioral practice, including bystander intervention techniques.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• identification as boys
• ages 15-17 years
• enrolled at public high schools in South Africa situated in communities with high rates of HIV and violence

Exclusion Criteria

• does not have written parental consent
• does not have written assent

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

American University

OTHER

Sponsor Role: collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Caroline Kuo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Kuo

Role: PRINCIPAL_INVESTIGATOR

American University and Brown University

Locations

Schools in Cape Town area

Cape Town, , South Africa

Countries

South Africa

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01MH129161

Identifier Type: NIH

Identifier Source: org_study_id

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