An Inter-disciplinary Approach to Understanding and Intervening on Contextual Factors That Shape HIV-risk for Young Women and Men in South Africa: Phase 2 - the Feasibility, Acceptability and Potential Effect Size of a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Physical Intimate Partner Violence
研究概览
简要总结
The goal of this randomised controlled clinical trial is to test the Stepping Stones and Creating Futures Plus (SSCF+) intervention, in young (18-25 years) people living in urban informal settlements in Durban and rural communities in KwaZulu-Natal, South Africa. The main questions it aims to answer are:
- Is the intervention acceptable and feasible
- What is the potential effect size on key outcomes of intimate partner violence
Participants will be randomised (1:1) to compare SSCF+ and a control arm to see if there are differences between the two on intimate partner violence.
详细描述
Intimate partner violence is very common in South Africa, particularly urban informal settlements. We have co-developed an intervention, called Stepping Stones and Creating Futures Plus (SSCF+), which will be evaluated in women and men aged 18-25 years living in KwaZulu-Natal, South Africa.
This is a pilot randomised controlled trial and as such there is focus on understanding whether the intervention is acceptable (to participants), feasible to deliver, and the potential effect sizes we may see in a full trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normally resident in the community where recruiting
- •Aged 18-30 years old
- •Not in formal employment, or full-time education
- •Able to communicate in the main languages of the study (English, isiXhosa or isiZulu)
- •Able to provide informed consent
排除标准
- •Only in the community temporarily
- •Unable to provide informed consent
- •Under 18 years of age, or over 31 years old at point of recruitment
- •Unable to communicate in main study languages
研究组 & 干预措施
SSCF+
Stepping Stones and Creating Futures Plus (SSCF+). Small group intervention, comprising approximately 15 sessions (each session ~3 hours), addressing gender, livelihoods, mental health.
干预措施: Stepping Stones and Creating Futures Plus (SSCF+) (Behavioral)
Control
No intervention control (wait-list)
结局指标
主要结局
Physical Intimate Partner Violence
时间窗: 6 months
Past 6 month experience (women) and perpetration (men) of physical IPV as assessed using WHO measure of IPV (5 items, binary)
Sexual Intimate Partner Violence
时间窗: 6 months
Past 6 month experience (women) and perpetration (men) of sexual IPV as assessed using WHO measure of IPV (3 items)
Severe Intimate partner violence
时间窗: 6 months
Past 6 month experience (women) and perpetration (men) of severe IPV as assessed using WHO IPV scale (8 items, coded into a binary)
次要结局
- Savings(6 months)
- Earnings(6 months)
- Livelihood Activities(6 months)
- Capabilities(6 months)
- Post-traumatic-stress symptoms(6 months)
- Hunger(6 months)
- Depressive symptoms(6 months)
- Emotional Dysregulation(6 months)
- Work stress(6 months)
- Work shame(6 months)
研究者
Andrew Gibbs
Senior Lecturer
University of Exeter