Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial) (Sonke CHANGE)

• ClinicalTrials.gov Identifier: NCT02823288
• Recruitment Status: Unknown
• First Posted: July 6, 2016
• Last Update Posted: October 26, 2017
• Sponsor: University of Witwatersrand, South Africa
• 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: June 28, 2016
• First Posted Date: July 6, 2016
• Last Update Posted Date: October 26, 2017
• Study Start Date: February 2016
• Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Domestic Violence
• Sexual Assault and Rape
• Masculinity

Intervention

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

• 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 *

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: October 24, 2017): 2603
• Original Estimated Enrollment (submitted: June 30, 2016): 2880
• Estimated Study Completion Date: August 2018
• Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: South Africa

Administrative Information

• NCT Number: NCT02823288
• Other Study ID Numbers: M150443
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

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.

• Current Responsible Party: Abigail Hatcher, University of Witwatersrand, South Africa
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Witwatersrand, South Africa
• Original Study Sponsor: Same as current

Collaborators

• Sonke Gender Justice
• Medical Research Council, South Africa
• Department for International Development, United Kingdom

Investigators

• Principal Investigator: Nicola J Christofides, PhD; University the Witwatersrand

• PRS Account: University of Witwatersrand, South Africa
• Verification Date: October 2017