Peer Education for Gender Inclusion and Substance Use in Southern Africa (NCT06489899) | Clinical Trial Compass
RecruitingNot Applicable
Peer Education for Gender Inclusion and Substance Use in Southern Africa
South Africa, Zambia, Zimbabwe264 participantsStarted 2024-09-19
Plain-language 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.
Who can participate
Age range
16 Years – 24 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.
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
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.
What they're measuring
1
Self-reported substance use for participants aged 18 and older
Timeframe: Change from baseline to 12-week follow-up assessment [range ≥8-20 weeks]
2
Self-reported substance use for participants aged 16 and 17
Timeframe: Change from baseline to 12-week follow-up assessment [range ≥8-20 weeks]