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Recruiting NCT06489899

NCT06489899 Peer Education for Gender Inclusion and Substance Use in Southern Africa

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Clinical Trial Summary
NCT ID NCT06489899
Status Recruiting
Phase
Sponsor University Hospital, Basel, Switzerland
Condition Substance Use
Study Type INTERVENTIONAL
Enrollment 264 participants
Start Date 2024-09-19
Primary Completion 2026-04

Eligibility & Interventions

Sex All sexes
Min Age 16 Years
Max Age 24 Years
Study Type INTERVENTIONAL
Interventions
PEGISUS

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 264 participants in total. It began in 2024-09-19 with a primary completion date of 2026-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of this trial is to test the effectiveness of a brief, behavioral peer group intervention called "PEGISUS" (Peer Education for Gender Inclusion and Substance Use in Southern Africa), on substance use, which will be embedded within existing vocational training programs in Zambia, Zimbabwe, and South Africa. Established peer groups who receive the PEGISUS intervention will complete nine sessions of an adapted intervention for substance use and gender equitable beliefs, embedded into vocational training programs. This will be compared to a standard of care control condition, which involves the vocational training program that is offered through the partner organization and a healthcare referral for substance use. The vocational training program partners are Sozo Foundation (South Africa), BuildIt International (Zambia), and Masvingo Polytechnic (Zimbabwe). Participants in both conditions will complete assessments at baseline, 12-weeks follow-up, and 24-weeks follow-up, consisting of self-reported questionnaires.

Eligibility Criteria

Inclusion Criteria: * Adolescents and young adults 16 - 24 years old * At least weekly self-reported alcohol/drug use in a peer group in the past month or at least monthly heavy episodic drinking with peers over the past three months * Comfortable communicating in the predominant local language or English * Lives in the target community and plans to remain in the area for the next 12 months * Eligible to participate in the vocational training (VT) program (according to the VT program's own entry guidelines) and willing to participate in the entirety of the program * Interested to participate in a substance reduction and gender equity beliefs program and able to identify 2 to 5 peers to join * Willing to have PEGISUS workshop sessions audio/video-recorded (if assigned to that group) Exclusion Criteria: * Untreated major mental illness that interferes with study participation, such as active suicidality, or unmanaged bipolar disorder or psychotic disorder * Currently receiving psychological treatment for substance use * Participation in another VT/skills development program or another trial that is judged by the site investigator as non-compatible with this study * Unable to provide informed consent or informed assent

Contact & Investigator

Central Contact

Tara Carney

✉ tara.carney@mrc.ac.za

📞 +27 21 938 0326

Principal Investigator

Jennifer M Belus, PhD

PRINCIPAL INVESTIGATOR

University Hospital, Basel, Switzerland

Frequently Asked Questions

Who can join the NCT06489899 clinical trial?

This trial is open to participants of all sexes, aged 16 Years or older, up to 24 Years, studying Substance Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06489899 currently recruiting?

Yes, NCT06489899 is actively recruiting participants. Contact the research team at tara.carney@mrc.ac.za for enrollment information.

Where is the NCT06489899 trial being conducted?

This trial is being conducted at Cape Town, South Africa, Chibombo, Zambia, Masvingo, Zimbabwe.

Who is sponsoring the NCT06489899 clinical trial?

NCT06489899 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Jennifer M Belus, PhD at University Hospital, Basel, Switzerland. The trial plans to enroll 264 participants.

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