Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa
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|ClinicalTrials.gov Identifier: NCT03179982|
Recruitment Status : Not yet recruiting
First Posted : June 7, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sexual Behavior Intimate Partner Violence||Behavioral: Safe South Africa||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Single Blind|
|Official Title:||Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
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
Core components of the Safe South Africa intervention include the following:
No Intervention: 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 acceptability [ Time Frame: 6 months ]satisfaction with intervention content using a Client Satisfaction Questionnaire that measures satisfaction using likert scale responses
- Intervention feasibility [ Time Frame: 6 months ]Measured by attendance rates at intervention sessions
- Intervention fidelity [ Time Frame: at each intervention session, coding will be conducted through study completion, an average of 2 years ]Measured by coding % of the time interventionists have fidelity to core intervention components
- Change from baseline in sexual behavior [ Time Frame: 6 months ]measured through rates of sexual risk behavior
- Change from baseline in Intimate Partner Violence (IPV) behavior [ Time Frame: 6 months ]measured through rates of IPV
- Change from baseline in bystander intervention behavior [ Time Frame: 6 months ]measured through rates of bystander intervention behavior
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179982
|Contact: Caroline Kuo||401 863 email@example.com|