NCT02823288

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,603

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

June 28, 2016

Last Update Submit

October 24, 2017

Conditions

Domestic ViolenceSexual Assault and RapeMasculinity

Keywords

intimate partner violencemasculinitycommunity mobilizationsocial interventionrape

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in severe violence

    12 months, 24 months

  • Change in controlling behavior

    12 months, 24 months

  • Change in gender attitudes

    12 months, 24 months

  • Change in harmful alcohol use

    12 months, 24 months

Study Arms (2)

Sonke CHANGE intervention condition

EXPERIMENTAL

This arm (n=9 clusters) will receive the Sonke CHANGE intervention for 12 months.

Other: Sonke CHANGE intervention

Control condition

NO INTERVENTION

In this arm (n=9 clusters), no activities will take place during the trial period outside of data collection.

Interventions

Sonke CHANGE interventionOTHER

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.

Sonke CHANGE intervention condition

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between 18 and 40 years of age (inclusive)
  • lives in a trial cluster
  • willing to participate on basis of written, informed consent

You may not qualify if:

  • younger than 18 years or older than 40 years
  • lives outside of a trial cluster
  • unwilling to participate or sign written, informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wits School of Public Health

Johannesburg, Gauteng, 2192, South Africa

Location

Related Publications (4)

  • 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.

    PMID: 35814730DERIVED

  • 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.

    PMID: 32424011DERIVED

  • 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.

    PMID: 32334615DERIVED

  • 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.

    PMID: 29574438DERIVED

Related Links

MeSH Terms

Conditions

Masculinity

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Nicola J Christofides, PhD

    University the Witwatersrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 6, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

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.

Locations

ZA(1)