Stepping Stones and Creating Futures Plus Pilot

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

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.

Study Overview

• Status: Completed
• Conditions: Intimate Partner Violence; Poverty
• Intervention / Treatment: Behavioral: Stepping Stones and Creating Futures Plus (SSCF+)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Durban, South Africa
    • South African Medical Research Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSCF+; Stepping Stones and Creating Futures Plus (SSCF+). Small group intervention, comprising approximately 15 sessions (each session ~3 hours), addressing gender, livelihoods, mental health.	Behavioral: Stepping Stones and Creating Futures Plus (SSCF+); Group-based intervention delivered to small friendship networks, by a facilitator.
No Intervention: Control; No intervention control (wait-list)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Mean score of depressive symptoms as assessed by the Center for Epidemiology Studies Depression Scale (CESD) comprising 20 items	6 months
Post-traumatic-stress symptoms	Post traumatic stress symptoms experienced in past week (mean) as assessed through the Harvard Trauma Questionnaire (16 items)	6 months
Emotional Dysregulation	Assessed via the Difficulties in Emotional Regulation Scale (DERS) short form, 16 items. Mean score.	6 months
Earnings	Self-reported past month earnings (South African Rand)	6 months
Savings	Self-report past month savings (South African Rand)	6 months
Hunger	Past month food insecurity assessed through the 3 items of the Household Food Insecurity Access Scale (HFIAS)	6 months
Livelihood Activities	Frequency of livelihood strengthening activities in the past 3 months, assessed through seven items	6 months
Work stress	Experience of stress because of lack of work and money assessed through 4 items	6 months
Work shame	Experience of shame because of lack of work and money assessed through 4 items	6 months
Capabilities	Experience of capabilities assessed through 5 items of a modified ICECAP scale	6 months

Collaborators and Investigators

• Sponsor: University of Exeter
• Collaborators: University College, London; Medical Research Council, South Africa
• Investigators: Principal Investigator: Rachel Jewkes, Medical Research Council, South Africa; Principal Investigator: Andrew Gibbs, University of Exeter; Principal Investigator: Jenevieve Mannell, University College, London

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Actual): November 28, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EC023-10/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be shared within 12 months of study completion on University of Exeter and South African Medical Research Council data repository.
• IPD Sharing Time Frame: 12 months from completion of study
• IPD Sharing Access Criteria: Freely available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No