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

NCT03179982 | Completed Results DMC

• 1 other identifier: R34MH113484
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sexual Behavior; Intimate Partner Violence

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Satisfaction With Intervention Content

  Satisfaction with intervention content is based off of a measure called the Client Satisfaction Questionnaire developed by Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: Development of a general scale. Evaluation and Program Planning. 1979;2:197-207. We focus on the question from that scale that assesses satisfaction with the program. The item asks, "How satisfied are you with the program you have received?" Participants could rank their satisfaction from: 1 = quite dissatisfied, 2 = mildly dissatisfied, 3 = mostly satisfied, 4 = very satisfied." Higher scores correspond with higher satisfaction with the intervention program.

  6 months

• Intervention Feasibility

  Feasibility is measured by ability to recruit the planned number of participants into the trial. We wanted to recruit at least 95% of the target number of planned participants. Feasibility is also measured by retention of trial participants at the final timepoint. A cut off of 75% retention of all participants enrolled in the trial at the final timepoint is viewed as a good result for feasibility.

  6 months

• Intervention Fidelity

  Fidelity was not based off a published measure. Rather, a neutral observer rated the facilitator's delivery skills and adherence to a manualized protocol for delivering the intervention that guided the consistent delivery of core theoretical components of the intervention. This neutral observer used the following rankings on a scale with rankings ranging from 1 (equating to a category labeled as low demonstration of skills, \<25% of the time) to 3 (equating to a category labeled as high demonstration of skills, \>75% of the time). An average ranking of 2.5 or more is seen as success for fidelity.

  From the start of the intervention delivery period to the end of the delivery period - a 2 month timespan in total.

Secondary Outcomes (3)

• Number of Participants Who Refused Sex at 6 Months

  6 months

• Number of Participants Engaging in Intimate Partner Violence at 6 Months

  6 months

• Change From Baseline in Likelihood of Bystander Intervention Behavior

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Safe South Africa BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 15 Years - 17 Years
• Gender Eligibility Details: Participants must identify as male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male adolescent
• years of age, inclusive of 15 and 17

You may not qualify if:

• parent/guardian does not provide consent
• adolescent does not provide assent

Sponsors & Collaborators

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

Study Sites (1)

South African Medical Research School

Cape Town, South Africa

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Caroline Kuo
• Organization: American University

ckuo@american.edu

2028853054

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 7, 2017
• Study Start: February 1, 2019
• Primary Completion: October 23, 2019
• Study Completion: May 31, 2021
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)