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Trial record 2 of 39 for:    ("sex behavior" OR "sexual behavior" OR "sex risk behavior") AND (teen OR adolescent) AND HIV risk | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Collaborators:
Medical Research Council, South Africa
Rhode Island Hospital
Information provided by (Responsible Party):
Caroline Kuo, Brown University

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.

Condition or disease Intervention/treatment Phase
Sexual Behavior Intimate Partner Violence Behavioral: Safe South Africa Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single Blind
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.

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

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.



Primary Outcome Measures :
  1. Intervention acceptability [ Time Frame: 6 months ]
    satisfaction with intervention content using a Client Satisfaction Questionnaire that measures satisfaction using likert scale responses

  2. Intervention feasibility [ Time Frame: 6 months ]
    Measured by attendance rates at intervention sessions

  3. 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


Secondary Outcome Measures :
  1. Change from baseline in sexual behavior [ Time Frame: 6 months ]
    measured through rates of sexual risk behavior

  2. Change from baseline in Intimate Partner Violence (IPV) behavior [ Time Frame: 6 months ]
    measured through rates of IPV

  3. Change from baseline in bystander intervention behavior [ Time Frame: 6 months ]
    measured through rates of bystander intervention behavior



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must identify as male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
Contact: Caroline Kuo 401 863 5453 caroline_kuo@brown.edu

Sponsors and Collaborators
Brown University
Medical Research Council, South Africa
Rhode Island Hospital

Responsible Party: Caroline Kuo, Assistant Professor, Brown University
ClinicalTrials.gov Identifier: NCT03179982     History of Changes
Other Study ID Numbers: R34MH113484 ( U.S. NIH Grant/Contract )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No