Peer Education for Gender Inclusion and Substance Use in Southern Africa

NCT ID: NCT06489899

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use Gender Role

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PEGISUS

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.

Group Type EXPERIMENTAL

PEGISUS

Intervention Type BEHAVIORAL

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

Standard of Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PEGISUS

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Peer Education for Gender Inclusion and Substance Use in Southern Africa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SolidarMed

OTHER

Sponsor Role collaborator

University of Zambia

OTHER

Sponsor Role collaborator

Medical Research Council, South Africa

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer M Belus, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SOZO Foundation

Cape Town, Western Cape, South Africa

Site Status RECRUITING

Build It International

Chibombo, , Zambia

Site Status RECRUITING

Masvingo Polytechnic

Masvingo, , Zimbabwe

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Africa Zambia Zimbabwe

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tara Carney

Role: CONTACT

+27 21 938 0326

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thulani Ketelo

Role: primary

+27218255529

Chilufya Kasutu

Role: primary

+260211267715

Bulisani Moyo

Role: primary

+26339253095

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32285449 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://www.equimundo.org/wp-content/uploads/2019/06/PM-Manhood-2-0-Program-Overview-v1-7-E.pdf

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AO202300095

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Project Vuselela Feasibility
NCT07117656 RECRUITING NA