Testing the Efficacy of Safe South Africa

Brown University

Status and phase: Active, not recruiting; Phase 3

Conditions: Intervention; Control

Treatments: Behavioral: Safe South Africa

Study type: Interventional

Funder types: Other

Identifiers

NCT06750107

R01MH129161 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 836 patients

Sex: Male

Ages: 15 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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836 participants in 2 patient groups

Behavioral Intervention Safe South Africa

Experimental group

Description:

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

Treatment:

Behavioral: Safe South Africa

Control of Standard Care

No Intervention group

Description:

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.