An interventional study of Safe South Africa in Sexual Behavior and Intimate Partner Violence, sponsored by Brown University. Completed at 1 site in South Africa. Open to male participants aged 15 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Brown University · Not applicable, Interventional, and Prevention
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.
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.
224 studies on the registry are indexed under Sexual Behavior; 30 are open to participants now.
This study's enrollment of 60 is below the median of 264 across 179 interventional studies indexed under Sexual Behavior.
Browse Sexual Behavior studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Safe South Africa
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: From the start of the intervention delivery period to the end of the delivery period - a 2 month timespan in total.
Number of Participants Who Refused Sex at 6 Months
Measured by comparing whether % of those who refused sex at 6 months versus baseline.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
| Milestone | Intervention | Control |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
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.
| Participants | Intervention |
|---|---|
| Number of Participants With Satisfaction With Intervention Content | 28 |
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.
| Participants | Intervention | Control |
|---|---|---|
| Intervention Feasibility | 30 | 30 |
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.
| rankings on a scale ranging from 1 to 3 | Intervention |
|---|---|
| Intervention Fidelity | 2.75 (1 to 3) |
Measured by comparing whether % of those who refused sex at 6 months versus baseline.
| Participants | Intervention | Control |
|---|---|---|
| Number of Participants Who Refused Sex at 6 Months | 24 | 24 |
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.
| Participants | Intervention | Control Arm |
|---|---|---|
| Number of Participants Engaging in Intimate Partner Violence at 6 Months | 0 | 4 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| Change From Baseline in Likelihood of Bystander Intervention Behavior | 27 (1 to 40) | 30 (1 to 40) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Control | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Intervention | Control | Total |
|---|---|---|---|
| <=18 years | 30 | 30 | 60 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 16 (15 to 17) | 16 (15 to 17) | 16 (15 to 17) |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 30 | 30 | 60 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 30 | 30 | 60 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| South Africa | 30 | 30 | 60 |
| Intimate Partner Violence (IPV) Behavior(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 7 | 6 | 13 |
| Sexual risk behavior - refusal of sex(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 17 | 17 | 34 |
| Likelhood of Bystander Intervention Behavior(score on a scale) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 29 (25 to 33) | 31 (28 to 35) | 30 (25 to 35) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2019 to primary completion in Oct 2019, 8 months.
Results were first posted in Jun 2025, 5 years 8 months after primary completion.
Of 106 non-industry interventional studies with no phase under Sexual Behavior, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 8 months is below that.
Counting every sponsor, half of 107 studies reached it within 23 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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