Peer Education for Gender Inclusion and Substance Use in Southern Africa

NCT06489899 | Recruiting

• 1 other identifier: AO202300095
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 2

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.

Conditions

Substance Use; Gender Role

Keywords

gender; substance use; Zimbabwe; Zambia; South Africa

Outcome Measures

Primary Outcomes (2)

• Self-reported substance use for participants aged 18 and older

  Self-report using the Alcohol, Smoking and Substance involvement Screening Test (ASSIST; for participants aged 18 and older). Higher scores indicate more substance use and associated problems.

  Change from baseline to 12-week follow-up assessment [range ≥8-20 weeks]

• Self-reported substance use for participants aged 16 and 17

  Self-report using the Alcohol, Smoking and Substance Involvement Screening Test for Youth (ASSIST-Y; for participants aged 16 and 17). Higher scores indicate more substance use and associated problems.

  Change from baseline to 12-week follow-up assessment [range ≥8-20 weeks]

Secondary Outcomes (7)

• Self-reported substance use for participants aged 18 and older

  Change from baseline to 24-week follow-up assessment [range >20-32 weeks]

• Self-reported substance use for participants aged 16 and 17

  Change from baseline to 24-week follow-up assessment [range >20-32 weeks]

• Self-reported gender equitable beliefs

  Change from baseline to 12-week follow-up assessment [range ≥8-20 weeks] and 24-week follow-up assessment [range >20-32 weeks]

• Attendance at vocational training program

  24-week follow-up assessment [range >20-32 weeks]

• Rate of completion of vocational program

  24-week follow-up assessment [range >20-32 weeks]

Study Arms (2)

PEGISUS

EXPERIMENTAL

PEGISUS is based on two existing evidence-based interventions: Reducing Alcohol and Drug use and other Problem behavior in Adolescent Learners (RAD-PAL) and Manhood 2.0. RAD-PAL was developed to target primary substance use and other challenging behaviors. Manhood 2.0 was developed to reduce traditional gender beliefs. These interventions have been adapted based on formative work with the target user group. PEGISUS will be embedded into existing vocational training programs and delivered by existing staff at these institutions.

Behavioral: PEGISUS

Standard of Care

NO INTERVENTION

Standard of care is receiving the vocational training program that is offered through the partner organization and a healthcare referral for substance use. The vocational training programs are SOZO Foundation (South Africa), Build It International (Zambia), and Masvingo Polytechnic (Zimbabwe). SOZO Foundation offers training in six different vocational areas, including hairstyling, coding, and nutrition. They also teach life skills. Build It International offers construction programs and support beyond initial training through connection to employment and mentorship. Masvingo Polytechnic offers many programs, including electrical engineering, welding, guidance counseling, motor mechanics, and catering.

Interventions

PEGISUS BEHAVIORAL

PEGISUS is an 8-session intervention for substance use and gender equitable beliefs.

Also known as: Peer Education for Gender Inclusion and Substance Use in Southern Africa

PEGISUS

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• SolidarMed: collaborator
• University of Zambia: collaborator
• Medical Research Council, South Africa: collaborator

Study Sites (3)

SOZO Foundation

Cape Town, Western Cape, 7975, South Africa

RECRUITING

Build It International

Chibombo, Zambia

RECRUITING

Masvingo Polytechnic

Masvingo, Zimbabwe

RECRUITING

Related Publications (1)

• Carney T, Johnson K, Carrico A, Myers B. Acceptability and feasibility of a brief substance use intervention for adolescents in Cape Town, South Africa: A pilot study. Int J Psychol. 2020 Dec;55(6):1016-1025. doi: 10.1002/ijop.12668. Epub 2020 Apr 13.

  PMID: 32285449 BACKGROUND

Related Links

• Program overview and final results of Manhood 2.0's effects on gender equitable beliefs

MeSH Terms

Conditions

Substance-Related Disorders; Coitus

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Sexual Behavior; Behavior

Study Officials

• Jennifer M Belus, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Carney

CONTACT

+27 21 938 0326; tara.carney@mrc.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 8, 2024
• Study Start: September 19, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: A de-identified dataset will be deposited in an open-access data repository at the end of the project and once the objectives specified in the protocol have been addressed.
• Access Criteria: The data can be accessed by the public, through creation of an account with Open Science Foundation, an open-access data repository.

Locations

ZA (1); ZI (1)