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

Gender Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129530
• Other study ID #: 11-2062
• Status: Completed
• Phase: N/A
• First received: April 30, 2014
• Last updated: January 4, 2016
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2502
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gender Relations

Intervention

Behavioral:
• Community Social Mobilization program

Locations

Country	Name	City	State
South Africa	MRC/WITS and Agincourt Rural Health Transition Research Unit	Bushbuckridge	Mpumalanga

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of California, San Francisco, University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Gender Equitable Mens Scale (GEMS)		Baseline and 24 months	No
Secondary	The number of unprotected sex acts		Baseline and 24 months	No
Secondary	Concurrency	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	No
Secondary	Experience of perpetration of Intimate partner violence (IPV)		Baseline and 24 months	No