NCT02129530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

April 30, 2014

Last Update Submit

January 4, 2016

Conditions

Keywords

Community MobilizationHIVIntimate Partner ViolenceGender Norms

Outcome Measures

Primary Outcomes (1)

  • Changes in Gender Equitable Mens Scale (GEMS)

    Baseline and 24 months

Secondary Outcomes (3)

  • The number of unprotected sex acts

    Baseline and 24 months

  • Concurrency

    Baseline and 24 months

  • Experience of perpetration of Intimate partner violence (IPV)

    Baseline and 24 months

Study Arms (2)

Community Social Mobilization Program

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

The Control Arm does not receive the Community Mobilization Intervention

Interventions

Community Social Mobilization Program

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC/WITS and Agincourt Rural Health Transition Research Unit

Bosbokrand, Mpumalanga, South Africa

Location

Related Publications (2)

  • Pettifor A, Lippman SA, Gottert A, Suchindran CM, Selin A, Peacock D, Maman S, Rebombo D, Twine R, Gomez-Olive FX, Tollman S, Kahn K, MacPhail C. Community mobilization to modify harmful gender norms and reduce HIV risk: results from a community cluster randomized trial in South Africa. J Int AIDS Soc. 2018 Jul;21(7):e25134. doi: 10.1002/jia2.25134.

  • Pettifor A, Lippman SA, Selin AM, Peacock D, Gottert A, Maman S, Rebombo D, Suchindran CM, Twine R, Lancaster K, Daniel T, Gomez-Olive FX, Kahn K, MacPhail C. A cluster randomized-controlled trial of a community mobilization intervention to change gender norms and reduce HIV risk in rural South Africa: study design and intervention. BMC Public Health. 2015 Aug 6;15:752. doi: 10.1186/s12889-015-2048-z.

Study Officials

  • Audrey Pettifor, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 2, 2014

Study Start

March 1, 2012

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations