Zithandani Stepping Stones and Creating Futures - Phase 2 Pilot (NCT06975137) | Clinical Trial Compass
CompletedNot Applicable
Zithandani Stepping Stones and Creating Futures - Phase 2 Pilot
South Africa104 participantsStarted 2025-07-08
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Individual inclusion:
* Aged 18-40 years,
* Reside in the selected community
* Not in full time permanent employment, or in full-time education
* Able to communicate in the main languages of the study (English, isiXhosa or isiZulu)
* Able and willing to provide informed consent to participate
Joint inclusion criteria:
* Be a heterosexual couple
* Been together in a relationship for a minimum of 6 months
* Relationship is public knowledge
* Willing to participate in an intervention
Exclusion criteria individuals is as follows:
* Under 18 or 41+ years old
* Planning on leaving the community in the next 3 months
* Unable or unwilling to provide informed consent
* Unable to communicate in the main study languages
Joint couples exclusion criteria
* Relationship is not public knowledge
* Have been together for less than 6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.