Gender RelationsNCT02129530
Effect of Community Social Mobilization for the Prevention of HIV in Young South African Women
A study testing Community Social Mobilization program in people with Gender Relations, run by University of North Carolina, Chapel Hill at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Relations
- What is being tested?
- Community Social Mobilization program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,502 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
MRC/WITS and Agincourt Rural Health Transition Research Unit
Bosbokrand, Mpumalanga
About this study
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.
- Conditions
- Gender Relations
- Being tested
- Community Social Mobilization program
- Keywords
- Community Mobilization, HIV, Intimate Partner Violence, Gender Norms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Social Mobilization programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Social Mobilization program |
| Control Arm | No intervention | The Control Arm does not receive the Community Mobilization Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gender Equitable Mens Scale (GEMS)
Measured: Baseline and 24 months
Secondary outcomes (3)
The number of unprotected sex acts
Measured: Baseline and 24 months
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.
Measured: Baseline and 24 months
Experience of perpetration of Intimate partner violence (IPV)
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gender RelationsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, University of California, San Francisco
- Responsible party
- Principal investigator, Audrey Pettifor, PhD, University of North Carolina, Chapel Hill
- Investigators
- Audrey Pettifor, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129530
- Sponsor's protocol ID
- 11-2062
- Status last verified
- Jan 2016
- First submitted
- 30 Apr 2014
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29972287Pettifor 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.
PubMed 26245910
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Community Social Mobilization for the Prevention of HIV in Young South African Women
- ClinicalTrials.gov ID
- NCT02129530
- Acronym / sponsor ID
- 11-2062
- Conditions
- Gender Relations
- Keywords
- Community Mobilization, HIV, Intimate Partner Violence, Gender Norms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,502 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, University of California, San Francisco
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Social Mobilization Program | Experimental | Behavioral: Community Social Mobilization programA manualized intervention developed with Sonke Gender Justice Network using a workshop intervention manual and a community mobilization toolkit will be used. |
| Control Arm | No intervention | –The Control Arm does not receive the Community Mobilization Intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Social Mobilization program | Behavioural | Community Social Mobilization Program |
Primary outcome
Changes in Gender Equitable Mens Scale (GEMS)
Time frame: Baseline and 24 months
3 secondary outcomes
The number of unprotected sex acts
Time frame: Baseline and 24 months
Concurrency
Time frame: Baseline and 24 months
Experience of perpetration of Intimate partner violence (IPV)
Time frame: Baseline and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Derived from this study: PubMed 29972287Pettifor 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.
- Derived from this study: PubMed 26245910Pettifor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Pettifor, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Social Mobilization program in people with Gender Relations, run by University of North Carolina, Chapel Hill at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gender Equitable Mens Scale (GEMS) (time frame: Baseline and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02129530, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.