InterventionPhase 3NCT06750107
Testing the Efficacy of Safe South Africa
A Phase 3 study testing Safe South Africa in people with Intervention and Control, run by Brown University at 1 site in South Africa.
Trial summary
In this study, investigators will examine the efficacy of Safe South Africa, a behavioral intervention that is developmentally- and gender-tailored to prevent human immunodeficiency virus (HIV) and intimate partner violence (IPV) among adolescent boys. 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
- Intervention, Control
- What is being tested?
- Safe South Africa
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 836 participants
- Where
- 1 siteSouth Africa
- Study dates
- 22 Jan 2025to 30 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- identification as boys
- ages 15-17 years
- enrolled at public high schools in South Africa situated in communities with high rates of HIV and violence
Who cannot join
- does not have written parental consent
- does not have written assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Efficacy of Safe South Africa: An Intervention to Prevent HIV Risk and Interpersonal Violence Among Adolescent Boys
In this study, investigators will examine the efficacy of Safe South Africa, a behavioral intervention that is developmentally- and gender-tailored to prevent human immunodeficiency virus (HIV) and intimate partner violence (IPV) among adolescent boys. South Africa faces some of the highest global rates of HIV and IPV with sustained high incidence of HIV and alarming rates of IPV among adolescents and thus, is an ideal site to advance prevention science to tackle these urgent public health priorities. Testing the efficacy of an integrated intervention to prevent HIV risk behavior and IPV for adolescent boys can support optimal health for young people, their future partners, and society.
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. In this study, investigators build on previous scientific work that demonstrated the acceptability and feasibility of Safe South Africa, an integrated HIV-IPV intervention that uses a developmentally- and gender-tailored approach grounded in social norms theory to prevent adolescent HIV risk behavior and IPV. Investigators will conduct the work in South Africa, a country with the largest HIV epidemic and some of the highest rates of IPV in the world. The investigative team propose the following specific aims: (1) Tailoring Safe South Africa intervention content to address the unique behavioral and social norms data that drives HIV and IPV behaviors among boys in their socioecological environments. (2) Testing the efficacy of the Safe South Africa intervention in preventing HIV/STIs and reducing IPV frequency among N=836 adolescent boys (ages 15- 17), with the scientific team's working hypothesis that the intervention, relative to the usual care condition, will show (a) lower incidence of any STI (including HIV); and (b) reductions in IPV perpetration frequency and decreased endorsement of IPV supportive attitudes. (3) Identifying barriers and facilitators to implementing Safe South Africa within a school setting to provide data for future dissemination (presuming Safe South Africa is efficacious). Investigators will examine processes critical to future dissemination through (a) fidelity data examining adherence to core active components of the standardized intervention manual guiding consistent delivery of the intervention; and (b) qualitative data on the experience during and post-implementation from adolescents and stakeholders using N=20 in-depth interviews with each group.
- Conditions
- Intervention, Control
- Being tested
- Safe South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe South AfricaBehavioural
The Safe South Africa intervention is a developmentally-tailored intervention for adolescent boys, designed to reduce actual or intended HIV risk behaviors, actual or intended IPV perpetration frequency, and endorsement of IPV supportive attitudes. This intervention comprises 2-hour sessions, held once a week for a total of two weeks. The intervention also includes take-home activities to deepen behavioral engagement with received sessions and to "prime the pump" for up-coming sessions. Part 2 involves behavioral practice, including bystander intervention techniques.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention Safe South Africa | Experimental | This experimental behavioral intervention is designed to (a) lower incidence of sexually transmitted infections (gonorrhea, chlamydia and HIV); and (b) reductions in Intimate Partner Violence (IPV) perpetration frequency and decreased endorsement of IPV supportive attitudes Receives: Behavioral: Safe South Africa |
| Control of Standard Care | No intervention | The control arm will receive standard care. In South Africa, at the time of study planning there are no integrated HIV-IPV interventions that are evidence-based for this age group so the control group will not receive anything, reflective of what would be standard care in this setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in incidence of HIV and or Chlamydia and or Gonorrhoeae
Biologically verified Chlamydia trachomatis and/or Neisseria gonorrhoeae and/or HIV are measured as incident infections, defined as the number of participants in the sample who newly acquire HIV and/or Chlamydia and/or Gonorrhoeae as compared to the prior timepoint (this compares 12 month data to baseline). Chlamydia and Gonorrhoeae will be measured using urine sample using an assay (Discharge Multiplex PCR). HIV samples will be captured using a sterile single-person pricking tool is used to create a five dried blood spots card. Samples are tested using a 4th generation assay (Biorad Genscreen ULTRA HIV Ag-Ab assay).
Measured: 12 months
Reduction in acts of intimate partner violence
For those who have engaged in intimate touching, self-reported data on the number of completed acts of forced touching, oral sex, anal sex, and vaginal sex, as well as attempted acts of forced oral, anal, and vaginal sex are collecting using the Sexual Experiences Survey (SES) Short Form Perpetration (SES-SFP) is a survey tool developed by Mary P. Koss (Koss, M. P., Abbey, A., Campbell, R., Cook, S., Norris, J., Testa, M., Ullman, S., West, C., \& White, J. (2007). Revising the SES: A Collaborative Process to Improve Assessment of Sexual Aggression and Victimization. Psychology of Women Quarterly, 31(4), 357-370. https://doi.org/10.1111/j.1471-6402.2007.00385.x). The number of participants who have engaged in one or more acts of completed or attempted forced touching are reported at the 12 month timepoint, as compared to prior timepoints.
Measured: 12 months
Lower proportion of those who have reduced endorsement of intimate partner violence supportive attitudes
For those who have engaged in intimate touching, self-reported data on endorsement of IPV supportive attitudes will be measured using the Rape Myth Acceptance Scale. At 12 months, we will compare the proportion of individuals who will lower their Rape Myth Acceptance (RMA) score between baseline and twelve months. The Rape Myth Acceptance Scale is: • Payne DL, Lonsway KA, Fitzgerald LF. Rape myth acceptance: Exploration of its structure and its measurement using the Illinois Rape Myth Acceptance Scale. Journal of Research in Personality 1999;33:27-68.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start22 Jan 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- American University, Medical Research Council, South Africa, Rhode Island Hospital
- Responsible party
- Principal investigator, Caroline Kuo, Brown University
- Investigators
- Caroline Kuo, Principal investigator, American University and Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750107
- Sponsor's protocol ID
- R01MH129161
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers may request de-identified data and this will be shared after final analysis of outcomes is complete.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Safe South Africa: An Intervention to Prevent HIV Risk and Interpersonal Violence Among Adolescent Boys
- ClinicalTrials.gov ID
- NCT06750107
- Acronym / sponsor ID
- R01MH129161
- Conditions
- Intervention, Control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 836 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- American University, Medical Research Council, South Africa, Rhode Island Hospital
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators will examine the efficacy of Safe South Africa, a behavioral intervention that is developmentally- and gender-tailored to prevent human immunodeficiency virus (HIV) and intimate partner violence (IPV) among adolescent boys. South Africa faces some of the highest global rates of HIV and IPV with sustained high incidence of HIV and alarming rates of IPV among adolescents and thus, is an ideal site to advance prevention science to tackle these urgent public health priorities. Testing the efficacy of an integrated intervention to prevent HIV risk behavior and IPV for adolescent boys can support optimal health for young people, their future partners, and society.
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. In this study, investigators build on previous scientific work that demonstrated the acceptability and feasibility of Safe South Africa, an integrated HIV-IPV intervention that uses a developmentally- and gender-tailored approach grounded in social norms theory to prevent adolescent HIV risk behavior and IPV. Investigators will conduct the work in South Africa, a country with the largest HIV epidemic and some of the highest rates of IPV in the world. The investigative team propose the following specific aims: (1) Tailoring Safe South Africa intervention content to address the unique behavioral and social norms data that drives HIV and IPV behaviors among boys in their socioecological environments. (2) Testing the efficacy of the Safe South Africa intervention in preventing HIV/STIs and reducing IPV frequency among N=836 adolescent boys (ages 15- 17), with the scientific team's working hypothesis that the intervention, relative to the usual care condition, will show (a) lower incidence of any STI (including HIV); and (b) reductions in IPV perpetration frequency and decreased endorsement of IPV supportive attitudes. (3) Identifying barriers and facilitators to implementing Safe South Africa within a school setting to provide data for future dissemination (presuming Safe South Africa is efficacious). Investigators will examine processes critical to future dissemination through (a) fidelity data examining adherence to core active components of the standardized intervention manual guiding consistent delivery of the intervention; and (b) qualitative data on the experience during and post-implementation from adolescents and stakeholders using N=20 in-depth interviews with each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention Safe South Africa | Experimental | Behavioral: Safe South AfricaThis experimental behavioral intervention is designed to (a) lower incidence of sexually transmitted infections (gonorrhea, chlamydia and HIV); and (b) reductions in Intimate Partner Violence (IPV) perpetration frequency and decreased endorsement of IPV supportive attitudes |
| Control of Standard Care | No intervention | –The control arm will receive standard care. In South Africa, at the time of study planning there are no integrated HIV-IPV interventions that are evidence-based for this age group so the control group will not receive anything, reflective of what would be standard care in this setting. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- identification as boys
- ages 15-17 years
- enrolled at public high schools in South Africa situated in communities with high rates of HIV and violence
Key exclusion criteria (2 listed)
- does not have written parental consent
- does not have written 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 |
|---|---|---|
| Safe South AfricaThe Safe South Africa intervention is a developmentally-tailored intervention for adolescent boys, designed to reduce actual or intended HIV risk behaviors, actual or intended IPV perpetration frequency, and endorsement of IPV supportive attitudes. This intervention comprises 2-hour sessions, held once a week for a total of two weeks. The intervention also includes take-home activities to deepen behavioral engagement with received sessions and to "prime the pump" for up-coming sessions. Part 2 involves behavioral practice, including bystander intervention techniques. | Behavioural | Behavioral Intervention Safe South Africa |
Primary outcome
Reduction in incidence of HIV and or Chlamydia and or Gonorrhoeae
Time frame: 12 months
Biologically verified Chlamydia trachomatis and/or Neisseria gonorrhoeae and/or HIV are measured as incident infections, defined as the number of participants in the sample who newly acquire HIV and/or Chlamydia and/or Gonorrhoeae as compared to the prior timepoint (this compares 12 month data to baseline). Chlamydia and Gonorrhoeae will be measured using urine sample using an assay (Discharge Multiplex PCR). HIV samples will be captured using a sterile single-person pricking tool is used to create a five dried blood spots card. Samples are tested using a 4th generation assay (Biorad Genscreen ULTRA HIV Ag-Ab assay).
Reduction in acts of intimate partner violence
Time frame: 12 months
For those who have engaged in intimate touching, self-reported data on the number of completed acts of forced touching, oral sex, anal sex, and vaginal sex, as well as attempted acts of forced oral, anal, and vaginal sex are collecting using the Sexual Experiences Survey (SES) Short Form Perpetration (SES-SFP) is a survey tool developed by Mary P. Koss (Koss, M. P., Abbey, A., Campbell, R., Cook, S., Norris, J., Testa, M., Ullman, S., West, C., \& White, J. (2007). Revising the SES: A Collaborative Process to Improve Assessment of Sexual Aggression and Victimization. Psychology of Women Quarterly, 31(4), 357-370. https://doi.org/10.1111/j.1471-6402.2007.00385.x). The number of participants who have engaged in one or more acts of completed or attempted forced touching are reported at the 12 month timepoint, as compared to prior timepoints.
Lower proportion of those who have reduced endorsement of intimate partner violence supportive attitudes
Time frame: 12 months
For those who have engaged in intimate touching, self-reported data on endorsement of IPV supportive attitudes will be measured using the Rape Myth Acceptance Scale. At 12 months, we will compare the proportion of individuals who will lower their Rape Myth Acceptance (RMA) score between baseline and twelve months. The Rape Myth Acceptance Scale is: • Payne DL, Lonsway KA, Fitzgerald LF. Rape myth acceptance: Exploration of its structure and its measurement using the Illinois Rape Myth Acceptance Scale. Journal of Research in Personality 1999;33:27-68.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. Other researchers may request de-identified data and this will be shared after final analysis of outcomes is complete.
Related trials for Intervention
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
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.
Caroline Kuo principal investigator
American University and Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Safe South Africa in people with Intervention and Control, 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 3 Jun 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in incidence of HIV and or Chlamydia and or Gonorrhoeae (time frame: 12 months). The study lists 3 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 3 Jun 2026.