Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202502629432188 Date of Registration: 14/02/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Peer Education for Gender Inclusion and Substance Use in Southern Africa (PEGISUS)
Official scientific title Peer Education for Gender Inclusion and Substance Use in Southern Africa (PEGISUS): A Pilot Trial Testing a Peer-based Intervention in Vocational Training Programs
Brief summary describing the background and objectives of the trial 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PEGISUS
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/02/2025
Actual trial start date
Anticipated date of last follow up 31/07/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 264
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of Care n/a 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. 132 Placebo
Experimental Group PEGISUS Peer Education for Gender Inclusion and Substance Use in Southern Africa 8 sessions Approximately 1.5 hours per session 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. 132
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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) 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 Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 16 Year(s) 24 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/01/2024 South African Medical Research Council
Ethics Committee Address
Street address City Postal code Country
Francie van Zyl Drive, Tygerberg Bellville 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/02/2024 University of Zambia
Ethics Committee Address
Street address City Postal code Country
Ridgeway Campus Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/02/2024 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
20 Cambridge Road Harare 00263 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Self-reported substance use for participants aged 18 and older ASSIST baseline 12-week follow-up assessment
Primary Outcome Self-reported substance use for participants aged 16 and 17 ASSIST-Y Baseline 12-week follow-up assessment
Secondary Outcome Self-reported substance use for participants aged 18 and older Baseline 24-week follow-up assessment
Secondary Outcome Self-reported substance use for participants aged 16 and 17 ASSIST-Y Baseline baseline to 24-week follow-up assessment
Secondary Outcome Self-reported gender equitable beliefs measured by adapted 23-item version of the Gender Equitable Men's Scale Baseline 12-week follow-up assessment 24-week assessment
Secondary Outcome Attendance at vocational training program number of months 24-week follow-up assessment
Secondary Outcome Rate of completion of vocational program number and percentage completed 24-week follow-up assessment
Secondary Outcome Employment 24-week follow-up assessment
Secondary Outcome Income 24-week follow-up assessment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sozo Foundation Vrygrond Avenue, Vrygrond Cape Town 7975 South Africa
Build It International Great North Road Chibombo 9317 Zambia
Masvingo Polytechnic Beitbridge Road Masvingo Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
SOR4D Wildhainweg 3 Bern Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Basel Petersgraben 4 Basel 4301 Switzerland University
COLLABORATORS
Name Street address City Postal code Country
SolidarMed Obergrundstrasse 97 Lucerne 6005 Switzerland
University of Zambia Ridgeway Campus Lusaka 32379 Zambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jennifer Belus Jennifer.Belus@usb.ch +41764839837 Petersplatz 1
City Postal code Country Position/Affiliation
Basel 4001 Switzerland senior lead
Role Name Email Phone Street address
Scientific Enquiries Tara Carney tara.carney@mrc.ac.za +279380326 Francie van Zyl Drive, Tygerberg
City Postal code Country Position/Affiliation
Bellville 7505 South Africa specialist scientist
Role Name Email Phone Street address
Public Enquiries Belinda Chamberlain belinda.chamberlain@mrc.ac.za +27219380947 Francie van Zyl Drive
City Postal code Country Position/Affiliation
Bellville 7505 South Africa Unit Contracts Administrator
Role Name Email Phone Street address
Scientific Enquiries Kudakwashe Madzeke K.Madzeke@solidarmed.ch +263732131619 33 Cary Street
City Postal code Country Position/Affiliation
Masvingo Zimbabwe Country Director SolidarMed Zimbabwe
Role Name Email Phone Street address
Scientific Enquiries Anitha Menon anithamenon316@gmail.com +260977846116 Great East Road Campus PO Box 32379
City Postal code Country Position/Affiliation
Lusaka Zambia Professor of Health Psychology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The relevant anonymized data and statistical code will be deposited alongside the published peer-reviewed papers, in alignment with data sharing and verification procedures. Other investigators wishing to access the data for additional analyses can contact the study PI so that the appropriate documents (e.g., data sharing, ethics approvals) can be arranged. Analytic Code,Statistical Analysis Plan,Study Protocol 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. The data can be accessed by the public, through creation of an account with Open Science Foundation, an open-access data repository.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/02/2025 Group size changed to the expected number of participants randomized to the control group: standard of care Control Group, Standard of Care, , n/a, 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., 6, Placebo Control Group, Standard of Care, , n/a, 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., 132, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/02/2025 group changed to total number participants expected to be randomized to the intervention Experimental Group, PEGISUS Peer Education for Gender Inclusion and Substance Use in Southern Africa, 8 sessions, Approximately 1.5 hours per session, 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., 6, Experimental Group, PEGISUS Peer Education for Gender Inclusion and Substance Use in Southern Africa, 8 sessions, Approximately 1.5 hours per session, 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., 132,
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 11/02/2025 added contact person for study in Zimbabwe Scientific Enquiries, Kudakwashe , Madzeke, Dr., K.Madzeke@solidarmed.ch, , +263732131619, 33 Cary Street, Masvingo, , Zimbabwe, Country Director SolidarMed Zimbabwe
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 11/02/2025 added contact person for study in Zambia Scientific Enquiries, Anitha, Menon, Prof., anithamenon316@gmail.com, , +260977846116, Great East Road Campus PO Box 32379 , Lusaka, , Zambia, Professor of Health Psychology