Effect of Community Social Mobilization for the Prevention of HIV in Young South African Women

January 4, 2016 updated by: Audrey Pettifor, PhD, University of North Carolina, Chapel Hill
The overall purpose is to assess whether a community social mobilization (CSM) program focused on young men ages 18-35 years of age changes gender norms in the community. The secondary purpose is to determine if there is a combined effect of CSM and HPTN 068 (Conditional Cash Transfers) on HIV and HSV-2 incidence. The goal of the mobilization activities is to engage young men around the issues of gender norms, intimate partner violence and HIV risk and to encourage them to take action to protect young women and reduce HIV risk in their communities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2502

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Mpumalanga
      • Bushbuckridge, Mpumalanga, South Africa
        • MRC/WITS and Agincourt Rural Health Transition Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Quantitative Work

  • Men and women ages 18-35 years
  • Have lived in study area continuously for the past 12 months
  • Able and willing to provide informed consent

Qualitative Work

  • Men and women ages 18-99 years
  • A community member, CAT member or community mobilizer
  • Able and willing to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Community Social Mobilization Program
A manualized intervention developed with Sonke Gender Justice Network using a workshop intervention manual and a community mobilization toolkit will be used.
Behavioral: Community Social Mobilization program
No Intervention: Control Arm
The Control Arm does not receive the Community Mobilization Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Gender Equitable Mens Scale (GEMS)
Time Frame: Baseline and 24 months
Baseline and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of unprotected sex acts
Time Frame: Baseline and 24 months
Baseline and 24 months
Concurrency
Time Frame: Baseline and 24 months
The investigators will measure concurrency by assessing the date of first and last sex and whether a relationship is ongoing among the last 3 partners in the last 12 months.
Baseline and 24 months
Experience of perpetration of Intimate partner violence (IPV)
Time Frame: Baseline and 24 months
Baseline and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

University of California, San Francisco
University of Witwatersrand, South Africa

Investigators

  • Principal Investigator: Audrey Pettifor, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-2062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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