Domestic ViolenceSonke CHANGENCT02823288
Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)
A study testing Sonke CHANGE intervention in people with Domestic Violence and Sexual Assault and Rape, run by University of Witwatersrand, South Africa at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, Sexual Assault and Rape, Masculinity
- What is being tested?
- Sonke CHANGE intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,603 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 18 and 40 years of age (inclusive)
- lives in a trial cluster
- willing to participate on basis of written, informed consent
Who cannot join
- younger than 18 years or older than 40 years
- lives outside of a trial cluster
- unwilling to participate or sign written, informed consent
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Wits School of Public Health
Johannesburg, Gauteng, 2192
About this study
Official title: Refinement and Evaluation of a Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)
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.
Read the 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.
- Conditions
- Domestic Violence, Sexual Assault and Rape, Masculinity
- Being tested
- Sonke CHANGE intervention
- Keywords
- intimate partner violence, masculinity, community mobilization, social intervention, rape
- Medical subject headings
- Masculinity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Sonke CHANGE intervention condition | Experimental | This arm (n=9 clusters) will receive the Sonke CHANGE intervention for 12 months. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months, 24 months
Secondary outcomes (4)
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.
Measured: 12 months, 24 months
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).
Measured: 12 months, 24 months
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.
Measured: 12 months, 24 months
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).
Measured: 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,603 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- Sonke Gender Justice, Medical Research Council, South Africa, Department for International Development, United Kingdom
- Responsible party
- Principal investigator, Abigail Hatcher, University of Witwatersrand, South Africa
- Investigators
- Nicola J Christofides, PhD, Principal investigator, University the Witwatersrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823288
- Sponsor's protocol ID
- M150443
- Acronym
- Sonke CHANGE
- Status last verified
- Oct 2017
- First submitted
- 28 Jun 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
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.
PubMed 35814730Gibbs 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.
PubMed 32424011Christofides 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.
PubMed 32334615Christofides 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.
PubMed 29574438
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement and Evaluation of a Multilevel Intervention for Preventing Men's Use of Violence in Urban South Africa (Sonke CHANGE Trial)
- ClinicalTrials.gov ID
- NCT02823288
- Acronym / sponsor ID
- Sonke CHANGE / M150443
- Conditions
- Domestic Violence, Sexual Assault and Rape, Masculinity
- Keywords
- intimate partner violence, masculinity, community mobilization, social intervention, rape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,603 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Collaborators
- Sonke Gender Justice, Medical Research Council, South Africa, Department for International Development, United Kingdom
- Study start
- Feb 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonke CHANGE intervention condition | Experimental | Other: Sonke CHANGE interventionThis arm (n=9 clusters) will receive the Sonke CHANGE intervention for 12 months. |
| Control condition | No intervention | –In this arm (n=9 clusters), no activities will take place during the trial period outside of data collection. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between 18 and 40 years of age (inclusive)
- lives in a trial cluster
- willing to participate on basis of written, informed consent
Key exclusion criteria (3 listed)
- younger than 18 years or older than 40 years
- lives outside of a trial cluster
- unwilling to participate or sign written, informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonke CHANGE interventionThe 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. | Other | Sonke CHANGE intervention condition |
Primary outcome
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.
4 secondary outcomes
Change in severe violence
Time frame: 12 months, 24 months
Change in controlling behavior
Time frame: 12 months, 24 months
Change in gender attitudes
Time frame: 12 months, 24 months
Change in harmful alcohol use
Time frame: 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Derived from this study: PubMed 35814730Hatcher 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.
- Derived from this study: PubMed 32424011Gibbs 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.
- Derived from this study: PubMed 32334615Christofides 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.
- Derived from this study: PubMed 29574438Christofides 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.
- Study Design BriefLink provided by the sponsor.
- Evidence Brief: Baseline FindingsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola J Christofides, PhD principal investigator
University the Witwatersrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonke CHANGE intervention in people with Domestic Violence and Sexual Assault and Rape, run by University of Witwatersrand, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intimate partner violence (time frame: 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02823288, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.