Clinical trial NCT03179982: Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa
Official title: Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Intimate Partner Violence
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: Rhode Island Hospital
First posted: 2017-06-07
Enrollment: 60
Sex: MALE
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention acceptability
timeFrame: 6 months
measure: Intervention feasibility
timeFrame: 6 months
measure: Intervention fidelity
timeFrame: at each intervention session, coding will be conducted through study completion, an average of 2 years
Secondary outcomes:
measure: Change from baseline in sexual behavior
timeFrame: 6 months
measure: Change from baseline in Intimate Partner Violence (IPV) behavior
timeFrame: 6 months
measure: Change from baseline in bystander intervention behavior
timeFrame: 6 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: South African Medical Research School
Study officials:
References: