Testing the Efficacy of Safe South Africa

NCT06750107 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: R01MH129161
• Study Type: interventional
• Target: 836
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervention; Control

Outcome Measures

Primary Outcomes (3)

• Reduction in incidence of HIV and or Chlamydia and or Gonorrhoeae

  Biologically verified Chlamydia trachomatis and/or Neisseria gonorrhoeae and/or HIV are measured as incident infections, defined as the number of participants in the sample who newly acquire HIV and/or Chlamydia and/or Gonorrhoeae as compared to the prior timepoint (this compares 12 month data to baseline). Chlamydia and Gonorrhoeae will be measured using urine sample using an assay (Discharge Multiplex PCR). HIV samples will be captured using a sterile single-person pricking tool is used to create a five dried blood spots card. Samples are tested using a 4th generation assay (Biorad Genscreen ULTRA HIV Ag-Ab assay).

  12 months

• Reduction in acts of intimate partner violence

  For those who have engaged in intimate touching, self-reported data on the number of completed acts of forced touching, oral sex, anal sex, and vaginal sex, as well as attempted acts of forced oral, anal, and vaginal sex are collecting using the Sexual Experiences Survey (SES) Short Form Perpetration (SES-SFP) is a survey tool developed by Mary P. Koss (Koss, M. P., Abbey, A., Campbell, R., Cook, S., Norris, J., Testa, M., Ullman, S., West, C., \& White, J. (2007). Revising the SES: A Collaborative Process to Improve Assessment of Sexual Aggression and Victimization. Psychology of Women Quarterly, 31(4), 357-370. https://doi.org/10.1111/j.1471-6402.2007.00385.x). The number of participants who have engaged in one or more acts of completed or attempted forced touching are reported at the 12 month timepoint, as compared to prior timepoints.

  12 months

• Lower proportion of those who have reduced endorsement of intimate partner violence supportive attitudes

  For those who have engaged in intimate touching, self-reported data on endorsement of IPV supportive attitudes will be measured using the Rape Myth Acceptance Scale. At 12 months, we will compare the proportion of individuals who will lower their Rape Myth Acceptance (RMA) score between baseline and twelve months. The Rape Myth Acceptance Scale is: • Payne DL, Lonsway KA, Fitzgerald LF. Rape myth acceptance: Exploration of its structure and its measurement using the Illinois Rape Myth Acceptance Scale. Journal of Research in Personality 1999;33:27-68.

  12 months

Study Arms (2)

Behavioral Intervention Safe South Africa

EXPERIMENTAL

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

Behavioral: Safe South Africa

Control of Standard Care

NO INTERVENTION

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.

Interventions

Safe South Africa 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.

Behavioral Intervention Safe South Africa

Eligibility Criteria

• Age: 15 Years - 17 Years
• Gender Eligibility Details: Identifies as a boy or man
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical Research Council, South Africa: collaborator
• Brown University: lead
• American University: collaborator
• Rhode Island Hospital: collaborator

Study Sites (1)

Schools in Cape Town area

Cape Town, South Africa

Location

Study Officials

• Caroline Kuo

  American University and Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

ZA (1)