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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
Sponsor:
Collaborators:
Sonke Gender Justice
Medical Research Council, South Africa
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Abigail Hatcher, University of Witwatersrand, South Africa

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date October 26, 2017
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2016)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)
Official Title  ICMJE Refinement and Evaluation of a Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)
Brief Summary South Africa has one of the highest rates of violence towards women globally. However, little is known about how to prevent men's use of violence. The Sonke CHANGE Trial tests an intervention that targets men as individuals, groups, and community members in a peri-urban setting in South Africa. Eighteen neighborhoods will be randomly assigned to either the intervention condition or a control group. By speaking to men at baseline, 12 months, and 24 months, investigators will learn whether violence and other health behaviors shift over time. Alongside the trial, qualitative research will explore how the intervention took place and why participants may change attitudes or behaviors.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Domestic Violence
  • Sexual Assault and Rape
  • Masculinity
Intervention  ICMJE 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:

  1. Workshops based on the premise that deeply held gender and sexuality beliefs can be critically examined and transformed in a reflective group setting. Workshops aim to challenge inequitable and harmful ideas about manhood and encourage men to take action to promote equality.
  2. Community Action Teams (CATs) are comprised of interested men and women, who mobilize on a voluntary basis around issues in their neighborhoods. Methods include ambush theatre, murals painting, door to door campaigns, street soccer festivals, rallies, and community dialogues.
  3. Local Advocacy is undertaken by CAT members, who aim to hold government and other duty bearers to account for VAWG prevention. CAT members join local community structures to advance community education and local government accountability.
Study Arms  ICMJE
  • Experimental: Sonke CHANGE intervention condition
    This arm (n=9 clusters) will receive the Sonke CHANGE intervention for 12 months.
    Intervention: Other: Sonke CHANGE intervention
  • No Intervention: Control condition
    In this arm (n=9 clusters), no activities will take place during the trial period outside of data collection.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 24, 2017)
2603
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2016)
2880
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02823288
Other Study ID Numbers  ICMJE M150443
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Current Responsible Party Abigail Hatcher, University of Witwatersrand, South Africa
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Witwatersrand, South Africa
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Sonke Gender Justice
  • Medical Research Council, South Africa
  • Department for International Development, United Kingdom
Investigators  ICMJE
Principal Investigator: Nicola J Christofides, PhD University the Witwatersrand
PRS Account University of Witwatersrand, South Africa
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP