Intimate Partner Violence, Sexual Behavior
Conditions
Brief 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.
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.
Interventions
BEHAVIORALSafe 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
Sponsors
Medical Research Council, South Africa
Rhode Island Hospital
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Single Blind
Eligibility
Sex/Gender
MALE
Age
15 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Male adolescent * 15-17 years of age, inclusive of 15 and 17
Exclusion criteria
* parent/guardian does not provide consent * adolescent does not provide assent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Satisfaction With Intervention Content | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Refused Sex at 6 Months | 6 months | Measured by comparing whether % of those who refused sex at 6 months versus baseline. |
| Number of Participants Engaging in Intimate Partner Violence at 6 Months | 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. |
| Change From Baseline in Likelihood of Bystander Intervention Behavior | 6 months | 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. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 16 years | 16 years | 16 years |
| Intimate Partner Violence (IPV) Behavior | 7 Participants | 6 Participants | 13 Participants |
| Likelhood of Bystander Intervention Behavior | 29 score on a scale | 31 score on a scale | 30 score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 30 Participants | 60 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Africa | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
| Sexual risk behavior - refusal of sex | 17 Participants | 17 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: 6 months
Population: We looked at retention over the trial timepoints.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Intervention Feasibility | 30 Participants |
| Control | Intervention Feasibility | 30 Participants |
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Intervention Fidelity | 2.75 rankings on a scale ranging from 1 to 3 |
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.
Time frame: 6 months
Population: Those exposed to the intervention were asked about acceptability.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Satisfaction With Intervention Content | 28 Participants |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Change From Baseline in Likelihood of Bystander Intervention Behavior | 27 score on a scale |
| Control | Change From Baseline in Likelihood of Bystander Intervention Behavior | 30 score on a scale |
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants Engaging in Intimate Partner Violence at 6 Months | 0 Participants |
| Control | Number of Participants Engaging in Intimate Partner Violence at 6 Months | 4 Participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants Who Refused Sex at 6 Months | 24 Participants |
| Control | Number of Participants Who Refused Sex at 6 Months | 24 Participants |