- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05869864
Schools Championing Safe South Africa
June 13, 2023 updated by: Caroline Kuo, Brown University
Schools Championing Safe South Africa: An Intervention Engaging Teachers and Students in Adolescent Prevention of HIV Risk and Intimate Partner Violence
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
282
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Caroline C Kuo
- Phone Number: 2028853054
- Email: ckuo@american.edu
Study Locations
-
-
-
Cape Town, South Africa
- South African Medical Research Council
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Half of the participants in the pilot will receive the experimental behavioral intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of acceptability of the intervention to participants
Time Frame: 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.
|
6 months
|
Feasibility of recruitment and retention of participants
Time Frame: 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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention or reduction of sexual behavior related to HIV acquisition risk.
Time Frame: 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.
|
6 months
|
Prevention or reduction of attempted or completed acts of intimate partner violence
Time Frame: 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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Estimated)
August 1, 2023
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
May 11, 2023
First Submitted That Met QC Criteria
May 19, 2023
First Posted (Actual)
May 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 15, 2023
Last Update Submitted That Met QC Criteria
June 13, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Schools Championing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prevention or Reduction of HIV Risk Behavior
-
Geisinger ClinicCompletedHealth Promotion | Prevention | Risk Reduction Behavior | TelehealthUnited States
-
University of Southern CaliforniaCenters for Disease Control and Prevention; Charles Drew University of Medicine...CompletedHIV | Risk Reduction BehaviorUnited States
-
Public Health Foundation Enterprises, Inc.San Francisco Department of Public Health; Alto PharmacyRecruitingHIV Prevention | Adherence, Medication | Risk Reduction | Pre-exposure Prophylaxis (PrEP)United States
-
China National Center for Cardiovascular DiseasesActive, not recruitingCardiovascular Diseases | Primary Prevention | Risk ReductionChina
-
Ministry of Health, TurkeyTurk Telekomunikasyon A.Ş., Istanbul, TurkeyCompletedPrimary Prevention | Lifestyle Risk Reduction | Digital HealthTurkey
-
Seattle Children's HospitalTickit Health SolutionsCompletedRisk Reduction BehaviorUnited States
-
University of Colorado, DenverNational Institute of Mental Health (NIMH)Active, not recruitingRisk Reduction BehaviorUnited States
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)CompletedHealth Behavior | Risk Reduction BehaviorUnited States
-
University of Colorado, DenverSmith-Richardson FoundationCompletedRisk Reduction Behavior | Reproductive BehaviorUnited States
Clinical Trials on Schools Championing Safe South Africa
-
Brown UniversityRhode Island Hospital; Medical Research Council, South AfricaCompletedSexual Behavior | Intimate Partner ViolenceSouth Africa
-
Penn State UniversityNational Institute on Drug Abuse (NIDA)CompletedSubstance-Related Disorders | Sexually Transmitted DiseasesSouth Africa
-
University of California, Los AngelesDuke UniversityRecruitingSuicidal IdeationUnited States
-
Claremont Graduate UniversityCompletedSun Safety | Sun Safe Schools | Prevention of Skin CancerUnited States
-
University of MichiganUniversity of California, San Francisco; Human Sciences Research CouncilRecruitingHuman Immunodeficiency VirusSouth Africa
-
Xiangya Hospital of Central South UniversityActive, not recruiting
-
Hunan Province Tumor HospitalNot yet recruiting
-
AbbottCompletedProstatic NeoplasmBelgium, Luxembourg
-
Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)Completed
-
American University of Beirut Medical CenterCompleted