Zithandani Stepping Stones and Creating Futures - Phase 2 Pilot

NCT ID: NCT06975137

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Intimate Partner Violence (IPV); Earning Outcomes; Mental Health; Couple Communication; Couple Conflict; Couples; Livelihoods

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Zithandani Stepping Stones and Creating Futures

Couples intervention delivered in groups of 4-7 heterosexual couples.

Group Type: EXPERIMENTAL

Zithandani Stepping Stones and Creating Futures

Intervention Type: BEHAVIORAL

Delivered to heterosexual couples. 14 group based sessions, with each session lasting approximately 3 hours. Sessions are delivered by two trained facilitators. Intervention focused on transforming gender norms, strengthening communication, reducing symptoms of poor mental health and improving relationship dynamics. Mixture of couples focused, same-gender discussions, and whole group discussions.

Interventions

Zithandani Stepping Stones and Creating Futures

Delivered to heterosexual couples. 14 group based sessions, with each session lasting approximately 3 hours. Sessions are delivered by two trained facilitators. Intervention focused on transforming gender norms, strengthening communication, reducing symptoms of poor mental health and improving relationship dynamics. Mixture of couples focused, same-gender discussions, and whole group discussions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Relationship is not public knowledge
• Have been together for less than 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Research Council, South Africa

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

Project Empower

OTHER

Sponsor Role: collaborator

University of Exeter

OTHER

Sponsor Role: lead

Responsible Party

Andrew Gibbs

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South African Medical Research Council

Durban, , South Africa

Countries

South Africa

Central Contacts

Andrew Gibbs

Role: CONTACT

a.gibbs@exeter.ac.uk

+44 (0)1392 722179

Facility Contacts

Yandisa Sikweyiya

Role: primary

yandisa.sikweyiya@mrc.ac.za

+27 31 203 4737

Other Identifiers

MR/X004090/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1633030

Identifier Type: -

Identifier Source: org_study_id