What Works to Prevent Violence Against Women and Girls in Madagascar

NCT06598553 | Enrolling By Invitation

• 1 other identifier: IRB00452498
• Study Type: interventional
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate a comprehensive sexual education program (CSE) delivered by Projet Jeune Leader (PJL), a women-led non-governmental program in Madagascar. The study will randomize 50 rural middle schools (grades 6-9), to either intervention (n=25) and control (n=25) schools. The CSE program will be implemented in the 25 intervention middle schools over the course of the school year (Sept-May) by trained PJL educators. Trained research assistants will conduct individual surveys at the beginning of the school year (baseline) and at the end of the school year (endline) with all students (ages 10-older) in both intervention and control schools. All student must have parental permission and provide informed consent to participate in the study, The surveys will include questions on demographics (e.g. age, sex/gender, grade, living situation), self-efficacy, bullying, physical abuse/violence, sexual harassment, sexual abuse and violence, harsh discipline at school and at home, gender/social norms, mental health and sexual and reproductive health. Teachers/school directors will also participate in the surveys, completing surveys at the beginning and end of the school year. The teacher/directors surveys will focus on health and safety of the students and school environment. In addition to the surveys, trained research assistants will conduct midline and endline qualitative interviews with a subsample of students, teachers and directors in the intervention schools to further explore the CSE intervention and impact on health and safety for students and teachers/directors.

Conditions

Comprehensive Sexual Education

Keywords

sexual education; adolescents; violence prevention; health

Outcome Measures

Primary Outcomes (4)

• Peer-to-peer violence victimization

  Score range 1-5; higher score indicates more experiences of peer to peer violence

  Baseline, Post-baseline 9 months

• Bullying

  Score range 1-5; higher score indicates more experiences of bullying

  Baseline, Post-baseline 9 months

• Dating violence

  Score range 1-5, higher score more experiences of dating violence

  Baseline, Post-baseline 9 months

• Harsh discipline in school

  Score range 1-5, higher score more experiences of harsh discipline

  Baseline, Post-baseline 9 months

Secondary Outcomes (6)

• Sexual health confidence

  Baseline, Post-baseline 9 months

• Gender equality

  Baseline, Post-baseline 9 months

• Attitudes about dating violence/partner violence

  Baseline, Post-baseline 9 months

• Self-confidence

  Baseline, Post-baseline 9 months

• Attitudes about healthy relationships

  Baseline, Post-baseline 9 months

Other Outcomes (4)

• Witness partner violence in home

  Baseline, Post-baseline 9 months

• Parental Support

  Baseline, Post-baseline 9 months

• Harsh discipline in home

  Baseline, Post-baseline 9 months

Study Arms (2)

Comprehensive Sexual Education

EXPERIMENTAL

All adolescents enrolled in intervention middle schools receive the 22 week program.

Behavioral: Projet Jeune Leader Comprehensive Sexual Education

Usual educational program

NO INTERVENTION

Usual education program

Interventions

Projet Jeune Leader Comprehensive Sexual Education BEHAVIORAL

PJL provides trained educators to deliver a 22 week comprehensive sexual education (CSE) curriculum in participating middle schools. All adolescents enrolled in the school receive the CSE program.

Comprehensive Sexual Education

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 10 years or older
• Adolescents enrolled in grades 6th-9th in participating intervention and control middle schools in targeted districts
• Teachers and Directors in intervention and control middle schools in targeted districts
• Parent and adolescent provide Informed consent
• Teacher/director provides informed consent

You may not qualify if:

• Less than 10 years old
• Not a student intervention or control middle schools
• Not a teacher/director at intervention or control middle schools
• No informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead
• Projet Jeune Leader: collaborator
• United Kingdom Foreign Commonwealth Development Office: collaborator

Study Sites (1)

Projet Jeune Leader

Fiananransoa, Madagascar

Location

Study Officials

• Nancy Glass, PhD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid effectiveness-implementation trial

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)