Clinical Trials Directory

Trials / Completed

CompletedNCT03179982

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Brown University · Academic / Other
Sex
Male
Age
15 Years – 17 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSafe South AfricaCore 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

Timeline

Start date
2019-02-01
Primary completion
2019-10-23
Completion
2021-05-31
First posted
2017-06-07
Last updated
2025-06-24
Results posted
2025-06-24

Locations

1 site across 1 country: South Africa

Source: ClinicalTrials.gov record NCT03179982. Inclusion in this directory is not an endorsement.