Stepping Stones and Creating Futures Plus Pilot

Intimate Partner Violence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05783336
• Other study ID #: EC023-10/2022
• Status: Completed
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: November 28, 2023

Study information

• Verified date: May 2024
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: November 28, 2023
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Intimate Partner Violence
• Poverty

Intervention

Behavioral:
• Stepping Stones and Creating Futures Plus (SSCF+)
Group-based intervention delivered to small friendship networks, by a facilitator.

Locations

Country	Name	City	State
South Africa	South African Medical Research Council	Durban

Sponsors (3)

Lead Sponsor	Collaborator
University of Exeter	Medical Research Council, South Africa, University College, London

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Intimate Partner Violence	Past 6 month experience (women) and perpetration (men) of physical IPV as assessed using WHO measure of IPV (5 items, binary)	6 months
Primary	Sexual Intimate Partner Violence	Past 6 month experience (women) and perpetration (men) of sexual IPV as assessed using WHO measure of IPV (3 items)	6 months
Primary	Severe Intimate partner violence	Past 6 month experience (women) and perpetration (men) of severe IPV as assessed using WHO IPV scale (8 items, coded into a binary)	6 months
Secondary	Depressive symptoms	Mean score of depressive symptoms as assessed by the Center for Epidemiology Studies Depression Scale (CESD) comprising 20 items	6 months
Secondary	Post-traumatic-stress symptoms	Post traumatic stress symptoms experienced in past week (mean) as assessed through the Harvard Trauma Questionnaire (16 items)	6 months
Secondary	Emotional Dysregulation	Assessed via the Difficulties in Emotional Regulation Scale (DERS) short form, 16 items. Mean score.	6 months
Secondary	Earnings	Self-reported past month earnings (South African Rand)	6 months
Secondary	Savings	Self-report past month savings (South African Rand)	6 months
Secondary	Hunger	Past month food insecurity assessed through the 3 items of the Household Food Insecurity Access Scale (HFIAS)	6 months
Secondary	Livelihood Activities	Frequency of livelihood strengthening activities in the past 3 months, assessed through seven items	6 months
Secondary	Work stress	Experience of stress because of lack of work and money assessed through 4 items	6 months
Secondary	Work shame	Experience of shame because of lack of work and money assessed through 4 items	6 months
Secondary	Capabilities	Experience of capabilities assessed through 5 items of a modified ICECAP scale	6 months