Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial) (Sonke CHANGE)
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|ClinicalTrials.gov Identifier: NCT02823288|
Recruitment Status : Unknown
Verified October 2017 by Abigail Hatcher, University of Witwatersrand, South Africa.
Recruitment status was: Active, not recruiting
First Posted : July 6, 2016
Last Update Posted : October 26, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Domestic Violence Sexual Assault and Rape Masculinity||Other: Sonke CHANGE intervention||Not Applicable|
This study will refine and evaluate a multi-level model for reducing violence against women and girls in urban South Africa.
The intervention is a refinement of an existing gender-transformative programme that includes community mobilisation and advocacy. Called the Sonke CHANGE intervention, it will extend beyond a conventional group-based workshop approach to address the multi-level nature of violence and create an enabling environment for men to embrace more equitable forms of masculinity. Given the strong associations between masculinities and men's use of partner violence, now is an opportune moment to test the Sonke CHANGE model to determine its impact on men's use of violence.
The multi-level Sonke intervention will be evaluated using a cluster randomised controlled trial design. In a peri-urban setting of Diepsloot, neighbourhood "clusters" (n=18) will be randomly assigned to receive the intervention or a wait-list condition. Baseline, 12 month, and 24 month measures will assess changes in primary outcomes (men's reported use of intimate partner and non-partner violence) and secondary outcomes (severe violence, masculinity norms, harmful alcohol use, mental health). Formative qualitative research will explore the environmental context of Diepsloot, community views on violence, men's mobility, and their experiences of fathering. A longitudinal process evaluation will explore intervention delivery, unfolding of the advocacy element of Sonke CHANGE intervention, and potential mechanisms to change amongst participants.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2603 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Refinement and Evaluation of a Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: Sonke CHANGE intervention condition
This arm (n=9 clusters) will receive the Sonke CHANGE intervention for 12 months.
Other: Sonke CHANGE intervention
The Sonke CHANGE intervention is a multi-level model aimed at individual, group, community, and societal levels. Sonke's programming is comprised of three core components:
No Intervention: Control condition
In this arm (n=9 clusters), no activities will take place during the trial period outside of data collection.
- Change in intimate partner violence [ Time Frame: 12 months, 24 months ]Men's use of violence towards an intimate partner will be measured using an adapted version of the questionnaire from the South African Medical Research Council's Study on Men's Health and Relationships (6, 61). The questionnaire includes items around emotional abuse, economic abuse, physical violence, and sexual violence. Primary outcomes will be defined as dichotomous outcomes: any use of physical violence and / or any use of sexual violence.
- Change in severe violence [ Time Frame: 12 months, 24 months ]Men's use of severe violence is defined as any instance of men reporting more than once response to a single physical or sexual IPV item OR a response of once or more than once to two or more physical and/or sexual items.
- Change in controlling behavior [ Time Frame: 12 months, 24 months ]Male Controlling Behaviour will be measured using the Pulerwitz Sexual Relationship Power and Control scale items (65). This scale has been validated in South Africa (66), and has been used by members of our team in previous studies (67).
- Change in gender attitudes [ Time Frame: 12 months, 24 months ]Gender Attitudes will be measured using the Gender Equitable Men's Scale (GEM Scale) (63), an 18-item Likert scale. Gender Norms will be comprised of similar items, but phrased in a Likert scale for whether a man's friends hold those beliefs.
- Change in harmful alcohol use [ Time Frame: 12 months, 24 months ]Harmful alcohol use will be measured using the Alcohol Use Disorders Identification Test (AUDIT), a 10-item scale designed to measure alcohol consumption and identify risks for alcohol abuse and dependence (62).
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|Ages Eligible for Study:||18 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- between 18 and 40 years of age (inclusive)
- lives in a trial cluster
- willing to participate on basis of written, informed consent
- younger than 18 years or older than 40 years
- lives outside of a trial cluster
- unwilling to participate or sign written, informed consent
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): NCT02823288
|Wits School of Public Health|
|Johannesburg, Gauteng, South Africa, 2192|
|Principal Investigator:||Nicola J Christofides, PhD||University the Witwatersrand|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Abigail Hatcher, Senior Researcher, University of Witwatersrand, South Africa|
|Other Study ID Numbers:||
|First Posted:||July 6, 2016 Key Record Dates|
|Last Update Posted:||October 26, 2017|
|Last Verified:||October 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Data will be available 5 years after the end of the research through an institutional repository managed by the South African MRC. Data sharing will be managed through an application process, whereby the original investigators will be invited to participate in future papers.|
intimate partner violence