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

Domestic Violence Clinical Trial

— Sonke CHANGE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02823288
• Other study ID #: M150443
• Status: Active, not recruiting
• Phase: N/A
• First received: June 28, 2016
• Last updated: October 24, 2017
• Start date: February 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2017
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2603
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Domestic Violence
• Masculinity
• Sexual Assault and Rape

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: 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. 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. 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.

Locations

Country	Name	City	State
South Africa	Wits School of Public Health	Johannesburg	Gauteng

Sponsors (4)

Lead Sponsor	Collaborator
University of Witwatersrand, South Africa	Department for International Development, United Kingdom, Medical Research Council, South Africa, Sonke Gender Justice

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intimate partner violence	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.	12 months, 24 months
Secondary	Change in severe violence	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.	12 months, 24 months
Secondary	Change in controlling behavior	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).	12 months, 24 months
Secondary	Change in gender attitudes	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.	12 months, 24 months
Secondary	Change in harmful alcohol use	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).	12 months, 24 months

External Links

•   Evidence Brief: Baseline Findings
•   Study Design Brief