跳至主要内容
临床试验/NCT02823288
NCT02823288Unknown不适用

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

University of Witwatersrand, South Africa2 个研究点 分布在 1 个国家目标入组 2,603 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
2,603
试验地点
2
主要终点
Change in intimate partner violence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Sonke CHANGE intervention condition

Experimental

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

干预措施: Sonke CHANGE intervention (Other)

Control condition

No Intervention

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

结局指标

主要结局

Change in intimate partner violence

时间窗: 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.

次要结局

  • 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)

研究者

发起方
University of Witwatersrand, South Africa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abigail Hatcher

Senior Researcher

University of Witwatersrand, South Africa

研究点 (2)

Loading locations...

相似试验

Multilevel Intervention for Preventing Men's Use of... | 临床试验