Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa

Sexual Behavior Clinical Trial

Official title:

Integrated Prevention of HIV Risk and Intimate Partner Violence Among Adolescents in South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179982
• Other study ID #: R34MH113484
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: October 23, 2019

Study information

• Verified date: April 2019
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 23, 2019
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Intimate Partner Violence
• Sexual Behavior

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
South Africa	South African Medical Research School	Cape Town

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Medical Research Council, South Africa, Rhode Island Hospital

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention acceptability	satisfaction with intervention content using a Client Satisfaction Questionnaire that measures satisfaction using likert scale responses	6 months
Primary	Intervention feasibility	Measured by attendance rates at intervention sessions	6 months
Primary	Intervention fidelity	Measured by coding % of the time interventionists have fidelity to core intervention components	at each intervention session, coding will be conducted through study completion, an average of 2 years
Secondary	Change from baseline in sexual behavior	measured through rates of sexual risk behavior	6 months
Secondary	Change from baseline in Intimate Partner Violence (IPV) behavior	measured through rates of IPV	6 months
Secondary	Change from baseline in bystander intervention behavior	measured through rates of bystander intervention behavior	6 months