Clinical trial NCT02823288: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Domestic Violence
Sexual Assault and Rape
Masculinity
Keywords: intimate partner violence
masculinity
community mobilization
social intervention
rape
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
Collaborators: name: Sonke Gender Justice
name: Medical Research Council, South Africa
name: Department for International Development, United Kingdom
First posted: 2016-07-06
Enrollment: 2603
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in intimate partner violence
timeFrame: 12 months, 24 months
Secondary outcomes:
measure: Change in severe violence
timeFrame: 12 months, 24 months
measure: Change in controlling behavior
timeFrame: 12 months, 24 months
measure: Change in gender attitudes
timeFrame: 12 months, 24 months
measure: Change in harmful alcohol use
timeFrame: 12 months, 24 months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Wits School of Public Health
state: Gauteng
Study officials:
affiliation: University the Witwatersrand
name: Nicola J Christofides, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.