Substance UsePEGISUSNCT06489899
Peer Education for Gender Inclusion and Substance Use in Southern Africa
A study testing PEGISUS in people with Substance Use and Gender Role, run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Substance Use, Gender Role
- What is being tested?
- PEGISUS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 19 Sep 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
South Africa1 site, 1 recruiting
- Recruiting
SOZO Foundation
Cape Town, Western Cape, 7975
Thulani Ketelo, +27218255529, thulani@thesozofoundation.co.za
Tara Carney, PhD
Zambia1 site, 1 recruiting
- Recruiting
Build It International
Chibombo
Chilufya Kasutu, +260211267715, c.kasutu@builditinternational.org
J. Anitha Menon, PhD
Zimbabwe1 site, 1 recruiting
- Recruiting
Masvingo Polytechnic
Masvingo
Bulisani Moyo, +26339253095, moyob@maspoly.ac.zw
Kudakwashe Madzeke, PhD
About this study
Official 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
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.
Read the detailed description
Adolescents and young adults (AYA) make up a large proportion of the population in sub-Saharan Africa (SSA), including in South Africa, Zambia, and Zimbabwe, but also face increasingly high levels of disability and mortality. This is influenced by high levels of substance use and occurs in a predominantly gender normative environment that places young men, women, and non-cisgender young people at risk. One of the primary risk factors for AYA substance use is having peers who also engage in substance use, however, treatments do not target peers. Adoption of traditional gender norms that favor men are also associated with worse health outcomes for both genders. For AYA boys/men, this includes substance use, sexual risk-taking behaviours, and engaging in intimate partner violence; for AYA girls/women, there is increased risk of acquiring sexually transmitted infections and HIV as well as poor educational attainment, such as school dropout. It is necessary to target such gender norms to improve health outcomes of both genders. Addressing these traditional gender beliefs during the AYA period may be more impactful than during adulthood. AYA education and/or vocational training (VT) programs increase chances for a successful future in a setting where employment of youth is generally low. Overall, key behaviors during the AYA period in SSA support well-being across the lifespan, including educational/ vocational attainment, developing healthy coping beyond substance use, and adoption of equitable gender norms. This study seeks to test a brief, behavioral intervention focused on substance use reduction and development of equitable gender norms, which will be delivered to peer groups enrolled in existing VT programs in South Africa, Zambia, and Zimbabwe.
- Conditions
- Substance Use, Gender Role
- Being tested
- PEGISUS
- Keywords
- gender, substance use, Zimbabwe, Zambia, South Africa
- Medical subject headings
- Substance-Related Disorders, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGISUSBehavioural
Also called Peer Education for Gender Inclusion and Substance Use in Southern Africa
PEGISUS is an 8-session intervention for substance use and gender equitable beliefs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Change from baseline to 24-week follow-up assessment [range >20-32 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.
Measured: Change from baseline to 24-week follow-up assessment [range >20-32 weeks]
Self-reported gender equitable beliefs
Self-report using the adapted 23-item version of the Gender Equitable Men's Scale. Items are scored on a 3-point likert scale with higher scores representing more equitable norms.
Measured: 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
Number of months of attendance in vocational training program.
Measured: 24-week follow-up assessment [range >20-32 weeks]
Rate of completion of vocational program
Number and percentage of participants that completed the vocational training program.
Measured: 24-week follow-up assessment [range >20-32 weeks]
Employment
Subsequent employment status will be taken from vocational training program records, supplemented with self-report.
Measured: 24-week follow-up assessment [range >20-32 weeks]
Income earned
Income earned will be taken from vocational training program records, supplemented with self-report.
Measured: 24-week follow-up assessment [range >20-32 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start19 Sep 2024
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- SolidarMed, University of Zambia, Medical Research Council, South Africa
- Responsible party
- Sponsor
- Investigators
- Jennifer M Belus, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489899
- Sponsor's protocol ID
- AO202300095
- Acronym
- PEGISUS
- Status last verified
- Sep 2025
- First submitted
- 28 Jun 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 32285449Carney T, Menon JA, Chiyokoma B, Madzeke K, Sanchez G, Johnson K, Basera M, Berweger A, Ruckstuhl L, Hansen S, Hofer L, Belus JM. Protocol for a cluster randomized controlled trial among young people and their peers to reduce substance use and inequitable gender beliefs in Southern Africa. Addict Sci Clin Pract. 2026 Oct 14;21(1):74. doi: 10.1186/s13722-026-00718-7.
PubMed 42870272
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06489899
- Acronym / sponsor ID
- PEGISUS / AO202300095
- Conditions
- Substance Use, Gender Role
- Keywords
- gender, substance use, Zimbabwe, Zambia, South Africa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- SolidarMed, University of Zambia, Medical Research Council, South Africa
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adolescents and young adults (AYA) make up a large proportion of the population in sub-Saharan Africa (SSA), including in South Africa, Zambia, and Zimbabwe, but also face increasingly high levels of disability and mortality. This is influenced by high levels of substance use and occurs in a predominantly gender normative environment that places young men, women, and non-cisgender young people at risk. One of the primary risk factors for AYA substance use is having peers who also engage in substance use, however, treatments do not target peers. Adoption of traditional gender norms that favor men are also associated with worse health outcomes for both genders. For AYA boys/men, this includes substance use, sexual risk-taking behaviours, and engaging in intimate partner violence; for AYA girls/women, there is increased risk of acquiring sexually transmitted infections and HIV as well as poor educational attainment, such as school dropout. It is necessary to target such gender norms to improve health outcomes of both genders. Addressing these traditional gender beliefs during the AYA period may be more impactful than during adulthood. AYA education and/or vocational training (VT) programs increase chances for a successful future in a setting where employment of youth is generally low. Overall, key behaviors during the AYA period in SSA support well-being across the lifespan, including educational/ vocational attainment, developing healthy coping beyond substance use, and adoption of equitable gender norms. This study seeks to test a brief, behavioral intervention focused on substance use reduction and development of equitable gender norms, which will be delivered to peer groups enrolled in existing VT programs in South Africa, Zambia, and Zimbabwe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEGISUS | Experimental | Behavioral: PEGISUSPEGISUS 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. |
| 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. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEGISUSAlso: Peer Education for Gender Inclusion and Substance Use in Southern AfricaPEGISUS is an 8-session intervention for substance use and gender equitable beliefs. | Behavioural | PEGISUS |
Primary outcome
Self-reported substance use for participants aged 18 and older
Time frame: Change from baseline to 12-week follow-up assessment [range ≥8-20 weeks]
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.
Self-reported substance use for participants aged 16 and 17
Time frame: Change from baseline to 12-week follow-up assessment [range ≥8-20 weeks]
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.
7 secondary outcomes
Self-reported substance use for participants aged 18 and older
Time frame: Change from baseline to 24-week follow-up assessment [range >20-32 weeks]
Self-reported substance use for participants aged 16 and 17
Time frame: Change from baseline to 24-week follow-up assessment [range >20-32 weeks]
Self-reported gender equitable beliefs
Time frame: 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
Time frame: 24-week follow-up assessment [range >20-32 weeks]
Rate of completion of vocational program
Time frame: 24-week follow-up assessment [range >20-32 weeks]
Employment
Time frame: 24-week follow-up assessment [range >20-32 weeks]
Income earned
Time frame: 24-week follow-up assessment [range >20-32 weeks]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 32285449Carney 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.
- Derived from this study: PubMed 42870272Carney T, Menon JA, Chiyokoma B, Madzeke K, Sanchez G, Johnson K, Basera M, Berweger A, Ruckstuhl L, Hansen S, Hofer L, Belus JM. Protocol for a cluster randomized controlled trial among young people and their peers to reduce substance use and inequitable gender beliefs in Southern Africa. Addict Sci Clin Pract. 2026 Oct 14;21(1):74. doi: 10.1186/s13722-026-00718-7.
- Program overview and final results of Manhood 2.0's effects on gender equitable beliefsLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Substance Use
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer M Belus, PhD principal investigator
University Hospital, Basel, Switzerland
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEGISUS in people with Substance Use and Gender Role, run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa, Zambia, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tara Carney (+27 21 938 0326, tara.carney@mrc.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported substance use for participants aged 18 and older (time frame: Change from baseline to 12-week follow-up assessment [range ≥8-20 weeks]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06489899, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.