- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02823288
Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial) (Sonke CHANGE)
Refinement and Evaluation of a Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gauteng
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Johannesburg, Gauteng, South Africa, 2192
- Wits School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- between 18 and 40 years of age (inclusive)
- lives in a trial cluster
- willing to participate on basis of written, informed consent
Exclusion Criteria:
- younger than 18 years or older than 40 years
- lives outside of a trial cluster
- unwilling to participate or sign written, informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sonke CHANGE intervention condition
This arm (n=9 clusters) will receive the Sonke CHANGE intervention for 12 months.
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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:
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No Intervention: Control condition
In this arm (n=9 clusters), no activities will take place during the trial period outside of data collection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in intimate partner violence
Time Frame: 12 months, 24 months
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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.
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12 months, 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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12 months, 24 months
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Change in controlling behavior
Time Frame: 12 months, 24 months
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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).
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12 months, 24 months
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Change in gender attitudes
Time Frame: 12 months, 24 months
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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.
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12 months, 24 months
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Change in harmful alcohol use
Time Frame: 12 months, 24 months
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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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12 months, 24 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nicola J Christofides, PhD, University the Witwatersrand
Publications and helpful links
General Publications
- Hatcher AM, Neilands TB, Rebombo D, Weiser SD, Christofides NJ. Food insecurity and men's perpetration of partner violence in a longitudinal cohort in South Africa. BMJ Nutr Prev Health. 2022 Feb 7;5(1):36-43. doi: 10.1136/bmjnph-2021-000288. eCollection 2022.
- Gibbs A, Dunkle K, Mhlongo S, Chirwa E, Hatcher A, Christofides NJ, Jewkes R. Which men change in intimate partner violence prevention interventions? A trajectory analysis in Rwanda and South Africa. BMJ Glob Health. 2020 May;5(5):e002199. doi: 10.1136/bmjgh-2019-002199.
- Christofides NJ, Hatcher AM, Rebombo D, McBride RS, Munshi S, Pino A, Abdelatif N, Peacock D, Levin J, Jewkes RK. Effectiveness of a multi-level intervention to reduce men's perpetration of intimate partner violence: a cluster randomised controlled trial. Trials. 2020 Apr 25;21(1):359. doi: 10.1186/s13063-020-4185-7. Erratum In: Trials. 2020 Jun 16;21(1):526.
- Christofides NJ, Hatcher AM, Pino A, Rebombo D, McBride RS, Anderson A, Peacock D. A cluster randomised controlled trial to determine the effect of community mobilisation and advocacy on men's use of violence in periurban South Africa: study protocol. BMJ Open. 2018 Mar 23;8(3):e017579. doi: 10.1136/bmjopen-2017-017579.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- M150443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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