Viewing Study NCT06489899



Ignite Creation Date: 2024-07-17 @ 11:43 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06489899
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-08
First Post: 2024-06-28

Brief Title: Peer Education for Gender Inclusion and Substance Use in Southern Africa
Sponsor: University Hospital Basel Switzerland
Organization: University Hospital Basel Switzerland

Study Overview

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
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PEGISUS
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 20-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 boysmen this includes substance use sexual risk-taking behaviours and engaging in intimate partner violence for AYA girlswomen 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 andor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None