Trial Outcomes & Findings for Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa (NCT NCT03179982)
NCT ID: NCT03179982
Last Updated: 2025-06-24
Results Overview
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.
COMPLETED
NA
60 participants
6 months
2025-06-24
Participant Flow
Participant milestones
| Measure |
Intervention
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.
Safe South Africa: 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
|
Control
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa
Baseline characteristics by cohort
| Measure |
Intervention
n=30 Participants
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.
Safe South Africa: 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
|
Control
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
16 years
n=5 Participants
|
16 years
n=7 Participants
|
16 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Intimate Partner Violence (IPV) Behavior
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sexual risk behavior - refusal of sex
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Likelhood of Bystander Intervention Behavior
|
29 score on a scale
n=5 Participants
|
31 score on a scale
n=7 Participants
|
30 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Those exposed to the intervention were asked about acceptability.
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.
Outcome measures
| Measure |
Intervention
n=30 Participants
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.
Safe South Africa: 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
|
Control
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.
|
|---|---|---|
|
Number of Participants With Satisfaction With Intervention Content
|
28 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: We looked at retention over the trial timepoints.
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.
Outcome measures
| Measure |
Intervention
n=30 Participants
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.
Safe South Africa: 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
|
Control
n=30 Participants
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.
|
|---|---|---|
|
Intervention Feasibility
|
30 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: From the start of the intervention delivery period to the end of the delivery period - a 2 month timespan in total.Population: We coded interventionist fidelity for core components of delivery to the intervention for those participating in the intervention using rankings on a scale ranging from 1 to 3
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.
Outcome measures
| Measure |
Intervention
n=30 Participants
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.
Safe South Africa: 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
|
Control
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.
|
|---|---|---|
|
Intervention Fidelity
|
2.75 rankings on a scale ranging from 1 to 3
Interval 1.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This study was not powered to determine efficacy but to look at promising direction of behavior change, and to generate data to inform effect sizes for a future fully powered efficacy trial.
Measured by comparing whether % of those who refused sex at 6 months versus baseline.
Outcome measures
| Measure |
Intervention
n=30 Participants
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.
Safe South Africa: 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
|
Control
n=30 Participants
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.
|
|---|---|---|
|
Number of Participants Who Refused Sex at 6 Months
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 6 monthsMeasured 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
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.
Safe South Africa: 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
|
Control
n=30 Participants
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.
|
|---|---|---|
|
Number of Participants Engaging in Intimate Partner Violence at 6 Months
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Intervention
n=30 Participants
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.
Safe South Africa: 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
|
Control
n=30 Participants
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.
|
|---|---|---|
|
Change From Baseline in Likelihood of Bystander Intervention Behavior
|
27 score on a scale
Interval 1.0 to 40.0
|
30 score on a scale
Interval 1.0 to 40.0
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place