Schools Championing Safe South Africa

Sponsor
Brown University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05869864
Collaborator
(none)
282
1
2
16
17.7

Study Details

Study Description

Brief Summary

This study explores the acceptability and feasibility of a school-based intervention called Schools Championing Safe South Africa that engages teachers and students in an integrated approach for preventing risk behavior related to acquisition of HIV and perpetration of IPV among adolescents in South Africa. Teachers and students are agents of change who can transform the school social environment to promote HIV and IPV prevention behaviors for adolescents.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Schools Championing Safe South Africa
Phase 1

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. Educational environments play a vital role in shaping behavioral choices among adolescent boys. Specifically, teachers and student peers serve as agents of change for adolescent boys' HIV and IPV prevention needs in four important ways. First, teachers and student peers influence community norms for appropriate adolescent male behaviors relating to dating, relationships, and sexual violence within the school ecology. Second, teachers and student peers have persistent contact with adolescents and thus, can play an influential role in adolescents' lives as role models for healthy norms. Third, teachers and student peers substantively motivate and reinforce protective behaviors relating to prevention of HIV and IPV. Fourth, teachers are ideally prepared to deliver age- and developmentally-tailored preventive interventions to adolescents because they are professionally trained to engage with adolescents in age and developmentally appropriate teaching. Despite the important role of teachers and student peers in promoting the health of adolescents, there are currently no HIV-IPV interventions in global priority settings for these epidemics that target teachers and student peers in school environments. In this study, we will develop and then investigate the acceptability and feasibility of Schools Championing Safe South Africa, an integrated HIV-IPV intervention where teachers and student peers engage adolescent boys in a developmentally-tailored approach to prevent adolescent HIV risk behavior and IPV using a social norms approach. Investigators work in South Africa, a country with the largest HIV epidemic and some of the highest rates of IPV in the world. This study explores the acceptability and feasibility of a school-based intervention called Schools Championing Safe South Africa that engages teachers and students in an integrated approach for preventing risk behavior related to acquisition of HIV and perpetration of IPV among adolescents in South Africa. Teachers and students are agents of change who can transform the school social environment to promote HIV and IPV prevention behaviors for adolescents.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
282 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The primary goal of this study is to assess acceptability of the behavioral intervention in a small group of participants and to determine feasibility of the study design for a future fully-powered clinical trial. The secondary goal of this study is to evaluate under-powered directions of behavior change relating to prevention or reduction of HIV risk behavior and intimate partner violence.The primary goal of this study is to assess acceptability of the behavioral intervention in a small group of participants and to determine feasibility of the study design for a future fully-powered clinical trial. The secondary goal of this study is to evaluate under-powered directions of behavior change relating to prevention or reduction of HIV risk behavior and intimate partner violence.
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Schools Championing Safe South Africa: An Intervention Engaging Teachers and Students in Adolescent Prevention of HIV Risk and Intimate Partner Violence
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Half of the participants in the pilot will receive the experimental behavioral intervention.

Behavioral: Schools Championing Safe South Africa
The intervention consists of 2 parts - a poster campaign with social norms messages on violence and HIV risk, and 2 lessons in life orientation (a health curriculum delivered during school).

No Intervention: Control

Half of the participants in the pilot will receive nothing, and serve as the control.

Outcome Measures

Primary Outcome Measures

  1. Rate of acceptability of the intervention to participants [6 months]

    Client Satisfaction Questionnaire - Using the client satisfaction questionnaire, investigators will measure satisfaction using likert scale responses that range from 1 to 5 with 5 aligning with high satisfaction with the intervention. Investigators are aiming for 80% of more of participants with rankings of satisfied or higher.

  2. Feasibility of recruitment and retention of participants [6 months]

    There is no scale for feasibility. Investigators will look at recruitment rates. Investigators will look at retention rates. Feasibility will be aligned with 75% or higher retention rates at the follow-up timepoints.

Secondary Outcome Measures

  1. Prevention or reduction of sexual behavior related to HIV acquisition risk. [6 months]

    This is an underpowered outcome because the primary goal of this study is not to evaluate efficacy. There is no scale for these behaviors. For this secondary outcome, investigators will examine whether rates of sexual risk behavior including actual or intended acts of unprotected sex decrease.

  2. Prevention or reduction of attempted or completed acts of intimate partner violence [6 months]

    This is an underpowered outcome because the primary goal of this study is not to evaluate efficacy. For this secondary outcome, investigators will examine if there is a decrease in incidents of attempted and completed acts of sexual violence.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 17 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • identifies as boy

  • 15-17 years of age inclusive

  • attends school where study is occurring

Exclusion Criteria:
  • unable to secure parental consent

  • unable to secure parental consent child assent

Contacts and Locations

Locations

Site City State Country Postal Code
1 South African Medical Research Council Cape Town South Africa

Sponsors and Collaborators

  • Brown University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Caroline Kuo, Associate Professor, Brown University
ClinicalTrials.gov Identifier:
NCT05869864
Other Study ID Numbers:
  • Schools Championing
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 22, 2023