Prevention or Reduction of HIV Risk Behavior, Prevention or Reduction of Intimate Partner Violence
Conditions
Brief summary
This study explores the acceptability and feasibility of a school-based intervention called Schools Championing Safe South Africa that engages teachers and students in an integrated approach for preventing risk behavior related to acquisition of HIV and perpetration of IPV among adolescents in South Africa. Teachers and students are agents of change who can transform the school social environment to promote HIV and IPV prevention behaviors for adolescents.
Detailed description
Adolescence presents an ideal developmental transition period for an integrated intervention targeting prevention of HIV risk behaviors and intimate partner violence (IPV) including sexual violence. Adolescent boys in particular, are at high risk for HIV and perpetration of IPV. Yet, few behavioral interventions integrate HIV-IPV prevention and are tailored for the unique developmental needs of adolescent boys. Educational environments play a vital role in shaping behavioral choices among adolescent boys. Specifically, teachers and student peers serve as agents of change for adolescent boys' HIV and IPV prevention needs in four important ways. First, teachers and student peers influence community norms for appropriate adolescent male behaviors relating to dating, relationships, and sexual violence within the school ecology. Second, teachers and student peers have persistent contact with adolescents and thus, can play an influential role in adolescents' lives as role models for healthy norms. Third, teachers and student peers substantively motivate and reinforce protective behaviors relating to prevention of HIV and IPV. Fourth, teachers are ideally prepared to deliver age- and developmentally-tailored preventive interventions to adolescents because they are professionally trained to engage with adolescents in age and developmentally appropriate teaching. Despite the important role of teachers and student peers in promoting the health of adolescents, there are currently no HIV-IPV interventions in global priority settings for these epidemics that target teachers and student peers in school environments. In this study, we will develop and then investigate the acceptability and feasibility of Schools Championing Safe South Africa, an integrated HIV-IPV intervention where teachers and student peers engage adolescent boys in a developmentally-tailored approach to prevent adolescent HIV risk behavior and IPV using a social norms approach. Investigators work in South Africa, a country with the largest HIV epidemic and some of the highest rates of IPV in the world. This study explores the acceptability and feasibility of a school-based intervention called Schools Championing Safe South Africa that engages teachers and students in an integrated approach for preventing risk behavior related to acquisition of HIV and perpetration of IPV among adolescents in South Africa. Teachers and students are agents of change who can transform the school social environment to promote HIV and IPV prevention behaviors for adolescents.
Interventions
BEHAVIORALSchools Championing Safe South Africa
The intervention consists of 2 parts - a poster campaign with social norms messages on violence and HIV risk, and 2 lessons in life orientation (a health curriculum delivered during school).
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Intervention model description
The primary goal of this study is to assess acceptability of the behavioral intervention in a small group of participants and to determine feasibility of the study design for a future fully-powered clinical trial. The secondary goal of this study is to evaluate under-powered directions of behavior change relating to prevention or reduction of HIV risk behavior and intimate partner violence.
Eligibility
Sex/Gender
MALE
Age
15 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* identifies as boy * 15-17 years of age inclusive * attends school where study is occurring
Exclusion criteria
* unable to secure parental consent * unable to secure parental consent child assent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Expressed Satisfaction With the Intervention | 6 months | Client Satisfaction Questionnaire - Using the client satisfaction questionnaire, investigators will measure satisfaction using likert scale responses that range from 1 to 5 with 5 aligning with high satisfaction with the intervention. Investigators are aiming for 80% of more of participants with rankings of satisfied or higher. The questionnaire is based off of the following measure: 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. Only participants in the intervention arm answer questions on satisfaction with the intervention. |
| Number of Participants Who Were Retained At the 6-month Time Point | 6 months | There is no scale for feasibility. Investigators will look at retention rates. Feasibility will be aligned with 75% or higher retention rates at the 6 month timepoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use. | 6 months | This is an underpowered outcome because the primary goal of this study is not to evaluate efficacy. There is no scale for these behaviors. For this secondary outcome, investigators will examine the percent of participants who engaged in lifetime condom use. This will be reported for each arm, comparing percentages engaged in lifetime condom use at the 6-month time point for each arm separately. |
| Prevention or Reduction of Attempted or Completed Acts of Intimate Partner Violence Using Mary Koss's Short Form Sexual Violence Perpetration Scale At the 1-month Time Point | 1 month | This is an underpowered outcome because the primary goal of this study is not to evaluate efficacy. For this secondary outcome, investigators will examine if there is a decrease in incidents of attempted and completed acts of sexual violence. The percentage of participants engaged in any completed act of sexual perpetration - defined as 1 or more acts of forced touching, oral sex, anal sex, and/or vaginal sex - will be compared for the intervention arm, looking at baseline versus 1 month. Similarly, the percentage of participants engaged in any completed act of sexual perpetration - defined as 1 or more acts of forced touching, oral sex, anal sex, and/or vaginal sex - will be compared for the control arm, looking at baseline versus 1 month. |
Countries
South Africa
Participant flow
Pre-assignment details
While teachers were exposed to the intervention (including the poster campaign), they were not the main target of the intervention.Thus, data on the primary outcomes of the study was not gathered from teachers.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Half of the participants in the pilot will receive the experimental behavioral intervention.
Schools Championing Safe South Africa: The intervention consists of 2 parts - a poster campaign with social norms messages on violence and HIV risk, and 2 lessons in life orientation (a health curriculum delivered during school). | 142 |
| Control Half of the participants in the pilot will receive nothing, and serve as the control. | 140 |
| Total | 282 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical Participants under 18 years <=18 years | 142 Participants | 140 Participants | 282 Participants |
| Age, Categorical Participants under 18 years >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Participants under 18 years Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black African | 142 Participants | 136 Participants | 278 Participants |
| Race/Ethnicity, Customized Coloured | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 3 Participants | 3 Participants |
| Region of Enrollment South Africa | 142 participants | 140 participants | 282 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 142 Participants | 140 Participants | 282 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 142 | 1 / 140 |
| other Total, other adverse events | 0 / 142 | 0 / 140 |
| serious Total, serious adverse events | 0 / 142 | 1 / 140 |
Outcome results
Primary
Number of Participants Who Expressed Satisfaction With the Intervention
Client Satisfaction Questionnaire - Using the client satisfaction questionnaire, investigators will measure satisfaction using likert scale responses that range from 1 to 5 with 5 aligning with high satisfaction with the intervention. Investigators are aiming for 80% of more of participants with rankings of satisfied or higher. The questionnaire is based off of the following measure: 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. Only participants in the intervention arm answer questions on satisfaction with the intervention.
Time frame: 6 months
Population: Participants assigned to the intervention arm, and who were exposed to the experimental intervention, answered questions on satisfaction with the intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants Who Expressed Satisfaction With the Intervention | 113 Participants |
Primary
Number of Participants Who Were Retained At the 6-month Time Point
There is no scale for feasibility. Investigators will look at retention rates. Feasibility will be aligned with 75% or higher retention rates at the 6 month timepoint.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants Who Were Retained At the 6-month Time Point | 140 Participants |
| Control | Number of Participants Who Were Retained At the 6-month Time Point | 139 Participants |
Secondary
Prevention or Reduction of Attempted or Completed Acts of Intimate Partner Violence Using Mary Koss's Short Form Sexual Violence Perpetration Scale At the 1-month Time Point
This is an underpowered outcome because the primary goal of this study is not to evaluate efficacy. For this secondary outcome, investigators will examine if there is a decrease in incidents of attempted and completed acts of sexual violence. The percentage of participants engaged in any completed act of sexual perpetration - defined as 1 or more acts of forced touching, oral sex, anal sex, and/or vaginal sex - will be compared for the intervention arm, looking at baseline versus 1 month. Similarly, the percentage of participants engaged in any completed act of sexual perpetration - defined as 1 or more acts of forced touching, oral sex, anal sex, and/or vaginal sex - will be compared for the control arm, looking at baseline versus 1 month.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Prevention or Reduction of Attempted or Completed Acts of Intimate Partner Violence Using Mary Koss's Short Form Sexual Violence Perpetration Scale At the 1-month Time Point | 78 Participants |
| Control | Prevention or Reduction of Attempted or Completed Acts of Intimate Partner Violence Using Mary Koss's Short Form Sexual Violence Perpetration Scale At the 1-month Time Point | 81 Participants |
Secondary
Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use.
This is an underpowered outcome because the primary goal of this study is not to evaluate efficacy. There is no scale for these behaviors. For this secondary outcome, investigators will examine the percent of participants who engaged in lifetime condom use. This will be reported for each arm, comparing percentages engaged in lifetime condom use at the 6-month time point for each arm separately.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use. | Number of participants engaged in lifetime condom use at 1 month | 95 Participants |
| Intervention | Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use. | Number of participants engaged in lifetime condom use at 6 months | 98 Participants |
| Control | Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use. | Number of participants engaged in lifetime condom use at 1 month | 92 Participants |
| Control | Prevention or Reduction of Sexual Behavior Related to HIV Acquisition Risk as Measured Through the Percent of Participants Engaged in Lifetime Condom Use. | Number of participants engaged in lifetime condom use at 6 months | 99 Participants |