Prevention or Reduction of HIV Risk BehaviorPhase 1NCT05869864
Schools Championing Safe South Africa
A Phase 1 study testing Schools Championing Safe South Africa in people with Prevention or Reduction of HIV Risk Behavior and Prevention or Reduction of Intimate Partner Violence, run by Brown University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention or Reduction of HIV Risk Behavior, Prevention or Reduction of Intimate Partner Violence
- What is being tested?
- Schools Championing Safe South Africa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteSouth Africa
- Study dates
- 31 Jan 2023to 22 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- identifies as boy
- 15-17 years of age inclusive
- attends school where study is occurring
Who cannot join
- unable to secure parental consent
- unable to secure parental consent child assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prevention or Reduction of HIV Risk Behavior, Prevention or Reduction of Intimate Partner Violence
- Being tested
- Schools Championing Safe South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schools Championing Safe South AfricaBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Half of the participants in the pilot will receive the experimental behavioral intervention. Receives: Behavioral: Schools Championing Safe South Africa |
| Control | No intervention | Half of the participants in the pilot will receive nothing, and serve as the control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Expressed Satisfaction With the Intervention
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. The questionnaire is based off of the following measure: 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.
Only participants in the intervention arm answer questions on satisfaction with the intervention.
Measured: 6 months
Number of Participants Who Were Retained At the 6-month Time Point
There is no scale for feasibility. Investigators will look at retention rates. Feasibility will be aligned with 75% or higher retention rates at the 6 month timepoint.
Measured: 6 months
Secondary outcomes (2)
Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use.
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 the percent of participants who engaged in lifetime condom use. This will be reported for each arm, comparing percentages engaged in lifetime condom use at the 6-month time point for each arm separately.
Measured: 6 months
Prevention or Reduction of Attempted or Completed Acts of Intimate Partner Violence Using Mary Koss's Short Form Sexual Violence Perpetration Scale At the 1-month Time Point
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. The percentage of participants engaged in any completed act of sexual perpetration - defined as 1 or more acts of forced touching, oral sex, anal sex, and/or vaginal sex - will be compared for the intervention arm, looking at baseline versus 1 month. Similarly, the percentage of participants engaged in any completed act of sexual perpetration - defined as 1 or more acts of forced touching, oral sex, anal sex, and/or vaginal sex - will be compared for the control arm, looking at baseline versus 1 month.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start31 Jan 2023
- Primary completion18 Oct 2023
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prevention or Reduction of HIV Risk BehaviorStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Kuo, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869864
- Sponsor's protocol ID
- Schools Championing
- Status last verified
- Jun 2025
- First submitted
- 11 May 2023
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schools Championing Safe South Africa: An Intervention Engaging Teachers and Students in Adolescent Prevention of HIV Risk and Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT05869864
- Acronym / sponsor ID
- Schools Championing
- Conditions
- Prevention or Reduction of HIV Risk Behavior, Prevention or Reduction of Intimate Partner Violence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Schools Championing Safe South AfricaHalf of the participants in the pilot will receive the experimental behavioral intervention. |
| Control | No intervention | –Half of the participants in the pilot will receive nothing, and serve as the control. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- identifies as boy
- 15-17 years of age inclusive
- attends school where study is occurring
Key exclusion criteria (2 listed)
- unable to secure parental consent
- unable to secure parental consent child assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schools Championing Safe South AfricaThe 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). | Behavioural | Intervention |
Primary outcome
Number of Participants Who Expressed Satisfaction With the Intervention
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. The questionnaire is based off of the following measure: 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. Only participants in the intervention arm answer questions on satisfaction with the intervention.
Number of Participants Who Were Retained At the 6-month Time Point
Time frame: 6 months
There is no scale for feasibility. Investigators will look at retention rates. Feasibility will be aligned with 75% or higher retention rates at the 6 month timepoint.
2 secondary outcomes
Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use.
Time frame: 6 months
Prevention or Reduction of Attempted or Completed Acts of Intimate Partner Violence Using Mary Koss's Short Form Sexual Violence Perpetration Scale At the 1-month Time Point
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Schools Championing Safe South Africa in people with Prevention or Reduction of HIV Risk Behavior and Prevention or Reduction of Intimate Partner Violence, run by Brown University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Expressed Satisfaction With the Intervention (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.