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| Name | Class |
|---|---|
| Medical Research Council, South Africa | OTHER |
| Rhode Island Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safe South Africa | Behavioral | Core components of the Safe South Africa intervention include the following:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From the start of the intervention delivery period to the end of the delivery period - a 2 month timespan in total. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Refused Sex at 6 Months | Measured by comparing whether % of those who refused sex at 6 months versus baseline. | 6 months |
| Number of Participants Engaging in Intimate Partner Violence at 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
Participants must identify as male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African Medical Research School | Cape Town | South Africa |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Those exposed to the intervention were asked about acceptability. | Posted | Count of Participants | Participants | 6 months |
|
6 months
We monitored any serious adverse event and adverse events including injury, death, and other harms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Kuo | American University | 2028853054 | ckuo@american.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2017 | May 13, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2019 | May 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Single Blind
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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.
| 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. | 6 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Age in years as reported by participants | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Intimate Partner Violence (IPV) Behavior | Perpetration of sexual violence was assessed using Mary Koss's Sexual Experiences Survey - Short Form Perpetration (SES-SFP). This 10-item measure captures frequency of attempted or completed sexual acts for vaginal sex and other forms of sexual contact, methods for perpetration, and if participants view these acts as rape. The measure allows for you to calculate the percentage of the sample who has completed 1 or more acts of forced sex (for example, 40% of the sample has engaged in 1 or more acts of forced sex). This is the type of analysis presented in the study. | Count of Participants | Participants |
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| Sexual risk behavior - refusal of sex | This is a self reported behavior - refusal of sex - relating to risk for acquisition of HIV | Count of Participants | Participants |
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| Likelhood 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. | Mean | Full Range | score on a scale |
|
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:
|
|
| Primary | 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. | We looked at retention over the trial timepoints. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | 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. | 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 | Posted | Mean | Full Range | rankings on a scale ranging from 1 to 3 | From the start of the intervention delivery period to the end of the delivery period - a 2 month timespan in total. |
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| Secondary | Number of Participants Who Refused Sex at 6 Months | Measured by comparing whether % of those who refused sex at 6 months versus baseline. | 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. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
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| Secondary | 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. | Posted | Mean | Full Range | score on a scale | 6 months |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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