Clinical Trial

Zithandani Stepping Stones and Creating Futures - Phase 2 Pilot

Completed
View on ClinicalTrials.gov →
Summary
The goal of this uncontrolled intervention study is to assess whether Zithandani Stepping Stones and Creating Futures is feasible to deliver, acceptable for participants, safe for participants and to estimate effect sizes, in young (ages 18-40 years) heterosexual couples, living in urban informal settlements in eThekwini Municipality, South Africa. The main questions it aims to answer are: 1. Is Zithandani SSCF feasible to deliver to young couples, and what are the barriers and opportunities in intervention delivery? 2. Is Zithandani SSCF acceptable to participants? What do they like and what do they not like about the intervention? 3. Is Zithandani SSCF safe for female participants and do they engage adequately? 4. Does Zithandani SSCF show indication of positive change on key indicators and what are the effect sizes? Participants will be recruited as heterosexual couples and participate in 14 sessions, each approximately 3 hours long, with between 4 and 6 other couples, focused on gender norms, livelihoods and communication.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-07; most recent amendment 2026-06-09.
Status change: Not Yet Recruiting → Completed 2026-06-09
Trial Details
NCT Number NCT06975137
Lead Sponsor University of Exeter
Collaborators: Medical Research Council, South Africa, University College, London, Project Empower
Conditions Intimate Partner Violence (IPV), Earning Outcomes, Mental Health, Couple Communication, Couple Conflict, Couples, Livelihoods
Enrollment 104 participants
Start Date 2025-07-08
Primary Completion 2025-11-21 (estimated)
Study Completion 2025-11-21 (estimated)
Updated on ClinicalTrials.gov 2026-06-11