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

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ClinicalTrials.gov Identifier: NCT02129530
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : January 6, 2016
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
University of California, San Francisco
Information provided by (Responsible Party):
Audrey Pettifor, PhD, University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gender Relations Behavioral: Community Social Mobilization program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Community Social Mobilization for the Prevention of HIV in Young South African Women
Study Start Date : March 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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



Primary Outcome Measures :
  1. Changes in Gender Equitable Mens Scale (GEMS) [ Time Frame: Baseline and 24 months ]

Secondary Outcome Measures :
  1. The number of unprotected sex acts [ Time Frame: Baseline and 24 months ]
  2. 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.

  3. Experience of perpetration of Intimate partner violence (IPV) [ Time Frame: Baseline and 24 months ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02129530


Locations
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South Africa
MRC/WITS and Agincourt Rural Health Transition Research Unit
Bushbuckridge, Mpumalanga, South Africa
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of Witwatersrand, South Africa
University of California, San Francisco
Investigators
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Principal Investigator: Audrey Pettifor, PhD University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Audrey Pettifor, PhD, Principal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02129530     History of Changes
Other Study ID Numbers: 11-2062
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016

Keywords provided by Audrey Pettifor, PhD, University of North Carolina, Chapel Hill:
Community Mobilization
HIV
Intimate Partner Violence
Gender Norms