Sexual BehaviorNCT03179982
Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa
A study testing Safe South Africa in people with Sexual Behavior and Intimate Partner Violence, run by Brown University at 1 site in South Africa.
Trial 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. 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
- Sexual Behavior, Intimate Partner Violence
- 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
- 60 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Feb 2019to 31 May 2021
- Phase
- Interventional
- 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
- Male adolescent
- 15-17 years of age, inclusive of 15 and 17
Who cannot join
- parent/guardian does not provide consent
- adolescent does not provide assent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Sexual Behavior, Intimate Partner Violence
- Being tested
- Safe South Africa
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe South AfricaBehavioural
Core 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Male adolescents (15-17 years) will be randomly allocated to an intervention arm based on permuted blocked randomization. The intervention arm will receive the HIV-IPV intervention called Safe South Africa.
Safe South Africa is a group-based, facilitated behavioral intervention for prevention of HIV risk and IPV perpetration specifically tailored for male adolescents. The behavioral intervention is comprised of 2-hour sessions, held once a week for a total of two weeks. Receives: Behavioral: Safe South Africa |
| Control | No intervention | Male adolescents (15-17 years) will be randomly allocated to a control arm based on permuted blocked randomization. The control arm will consist of ordinary usual care. The ordinary usual care condition will consist of a packet of existing available brochures on HIV and other sexually transmitted diseases including testing, prevention, and treatment; IPV prevention and intervention; and places to access prevention, care, and support for these outcomes and related health outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Satisfaction With Intervention Content
Satisfaction with intervention content is based off of a measure called the Client Satisfaction Questionnaire developed by 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.
We focus on the question from that scale that assesses satisfaction with the program. The item asks, "How satisfied are you with the program you have received?" Participants could rank their satisfaction from: 1 = quite dissatisfied, 2 = mildly dissatisfied, 3 = mostly satisfied, 4 = very satisfied." Higher scores correspond with higher satisfaction with the intervention program.
Measured: 6 months
Intervention Feasibility
Feasibility is measured by ability to recruit the planned number of participants into the trial. We wanted to recruit at least 95% of the target number of planned participants.
Feasibility is also measured by retention of trial participants at the final timepoint. A cut off of 75% retention of all participants enrolled in the trial at the final timepoint is viewed as a good result for feasibility.
Measured: 6 months
Intervention Fidelity
Fidelity was not based off a published measure. Rather, a neutral observer rated the facilitator's delivery skills and adherence to a manualized protocol for delivering the intervention that guided the consistent delivery of core theoretical components of the intervention. This neutral observer used the following rankings on a scale with rankings ranging from 1 (equating to a category labeled as low demonstration of skills, <25% of the time) to 3 (equating to a category labeled as high demonstration of skills, >75% of the time). An average ranking of 2.5 or more is seen as success for fidelity.
Measured: From the start of the intervention delivery period to the end of the delivery period - a 2 month timespan in total.
Secondary outcomes (3)
Number of Participants Who Refused Sex at 6 Months
Measured by comparing whether % of those who refused sex at 6 months versus baseline.
Measured: 6 months
Number of Participants Engaging in Intimate Partner Violence at 6 Months
Measured by examining whether the prevalence of those engaging in intimate partner violence (forced vaginal sex) was significantly lower at 6 months as compared to baseline.
Measured: 6 months
Change From Baseline in Likelihood of Bystander Intervention Behavior
The likelihood of engaging as an active bystander to stop violence is measured through the Bystander Behavior Scale, ranging from 1-40. The questions are answered on a 5-point Likert scale, ranging from 5 = "Very unlikely" to 1 = "Very likely". Lower scores correspond to more likelihood of intervening as an active bystander to stop violence, a measure developed by Miller E, Tancredi DJ, McCauley HL, Decker MR, Virata MCD, Anderson HA, et al. "Coaching Boys into Men": A Cluster-Randomized Controlled Trial of a Dating Violence Prevention Program. Journal of Adolescent Health. 2012;51(5):431-8.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Feb 2019
- Primary completion23 Oct 2019
- Study completion31 May 2021
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 Sexual 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, Rhode Island Hospital
- Responsible party
- Principal investigator, Caroline Kuo, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179982
- Sponsor's protocol ID
- R34MH113484
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2017
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa
- ClinicalTrials.gov ID
- NCT03179982
- Acronym / sponsor ID
- R34MH113484
- Conditions
- Sexual Behavior, Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, Rhode Island Hospital
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Safe South AfricaMale adolescents (15-17 years) will be randomly allocated to an intervention arm based on permuted blocked randomization. The intervention arm will receive the HIV-IPV intervention called Safe South Africa. Safe South Africa is a group-based, facilitated behavioral intervention for prevention of HIV risk and IPV perpetration specifically tailored for male adolescents. The behavioral intervention is comprised of 2-hour sessions, held once a week for a total of two weeks. |
| Control | No intervention | –Male adolescents (15-17 years) will be randomly allocated to a control arm based on permuted blocked randomization. The control arm will consist of ordinary usual care. The ordinary usual care condition will consist of a packet of existing available brochures on HIV and other sexually transmitted diseases including testing, prevention, and treatment; IPV prevention and intervention; and places to access prevention, care, and support for these outcomes and related health outcomes. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male adolescent
- 15-17 years of age, inclusive of 15 and 17
Key exclusion criteria (2 listed)
- parent/guardian does not provide consent
- adolescent does not provide 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 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 | Behavioural | Intervention |
Primary outcome
Number of Participants With Satisfaction With Intervention Content
Time frame: 6 months
Satisfaction with intervention content is based off of a measure called the Client Satisfaction Questionnaire developed by 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. We focus on the question from that scale that assesses satisfaction with the program. The item asks, "How satisfied are you with the program you have received?" Participants could rank their satisfaction from: 1 = quite dissatisfied, 2 = mildly dissatisfied, 3 = mostly satisfied, 4 = very satisfied." Higher scores correspond with higher satisfaction with the intervention program.
Intervention Feasibility
Time frame: 6 months
Feasibility is measured by ability to recruit the planned number of participants into the trial. We wanted to recruit at least 95% of the target number of planned participants. Feasibility is also measured by retention of trial participants at the final timepoint. A cut off of 75% retention of all participants enrolled in the trial at the final timepoint is viewed as a good result for feasibility.
Intervention Fidelity
Time frame: From the start of the intervention delivery period to the end of the delivery period - a 2 month timespan in total.
Fidelity was not based off a published measure. Rather, a neutral observer rated the facilitator's delivery skills and adherence to a manualized protocol for delivering the intervention that guided the consistent delivery of core theoretical components of the intervention. This neutral observer used the following rankings on a scale with rankings ranging from 1 (equating to a category labeled as low demonstration of skills, <25% of the time) to 3 (equating to a category labeled as high demonstration of skills, >75% of the time). An average ranking of 2.5 or more is seen as success for fidelity.
3 secondary outcomes
Number of Participants Who Refused Sex at 6 Months
Time frame: 6 months
Number of Participants Engaging in Intimate Partner Violence at 6 Months
Time frame: 6 months
Change From Baseline in Likelihood of Bystander Intervention Behavior
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 study testing Safe South Africa in people with Sexual Behavior and 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 2 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 24 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 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 With Satisfaction With Intervention Content (time frame: 6 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 24 Jun 2025.