Clinical trial NCT02129530: Effect of Community Social Mobilization for the Prevention of HIV in Young South African Women
Official title: Effect of Community Social Mobilization for the Prevention of HIV in Young South African Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender Relations
Keywords: Community Mobilization
HIV
Intimate Partner Violence
Gender Norms
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Witwatersrand, South Africa
name: University of California, San Francisco
First posted: 2014-05-02
Enrollment: 2502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Changes in Gender Equitable Mens Scale (GEMS)
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: The number of unprotected sex acts
timeFrame: Baseline and 24 months
measure: Concurrency
timeFrame: Baseline and 24 months
measure: Experience of perpetration of Intimate partner violence (IPV)
timeFrame: Baseline and 24 months
Other outcomes:
Locations:
city: Bushbuckridge
country: South Africa
facility: MRC/WITS and Agincourt Rural Health Transition Research Unit
state: Mpumalanga
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Audrey Pettifor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.