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Enrolling by Invitation

NCT Number: NCT06598553

What Works to Prevent Violence Against Women and Girls in Madagascar

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Projet Jeune Leader

Fiananransoa, Madagascar

About this study

Projet Jeune Leader (PJL) - a southern-based, youth-founded, women-led, women's rights organization - has mainstreamed gender-transformative comprehensive sexuality education (CSE) in Madagascar's public schools. PJL's mission is to improve adolescent learning and well-being - especially in rural and under-served communities. Comprehensive sexuality education (CSE) plays an important role in transforming harmful gender norms and reducing the risk of violence. As an evidence- and curriculum-based intervention, CSE supports youth in developing knowledge, attitudes, skills, intentions, and behaviors for safe, healthy, and gender equitable relationships. PJL's CSE intervention, in particular, has been shown to improve young and very young adolescent students' knowledge, attitudes, self-efficacy, and behavioral intentions toward sexual and reproductive health and rights and gender equality using pre-post school year evidence with comparison schools (Projet Jeune Leader impact summary, 2024). Community-engaged participatory research using Human-centered design (HCD) tools has also revealed that the intervention is impacting aspects of human development which can underpin violence prevention and response, including but not limited to increasing students' courage and confidence, enhancing student-teacher relationships, strengthening family relationships, providing role models in the community, and facilitating the fight against drugs and violence in the community.

Through a formal partnership signed May 2022, Madagascar's National Ministry of Education has committed to institutionalize PJL's model into the education system to reach all schools, especially those that serve the 80% of Madagascar's population living in rural areas. PJL's multi-level partnership with Madagascar's Ministry of Education is unique, and PJL is well-positioned to implement action-oriented research to examine the effect of their CSE intervention on key outcomes of young adolescent victimization and/or perpetration of bullying and violence, and knowledge, attitudes and self-efficacy on violence, gender equality, strengths and difficulties (mental health) and sexual and reproductive health. PJL will also explore the CSE intervention's indirect effects on young adolescent school outcomes (retention, progression) and "safe school environment." Further, CSE implementation reach, implementation, adoption and maintenance with participating middle schools.

The evaluation of the PJL CSE intervention will be conducted through a collaboration between Johns Hopkins University and PJL.The study will use a hybrid type 2 effectiveness-implementation design guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. School-based surveys will be used to measure outcomes at baseline (beginning of school year) and endline (end of school year, 9 months post baseline) with adolescents in 6th-9th grades, teachers and directors at middle schools randomized to either intervention or control schools in targeted rural areas. In addition, quantitative and qualitative methods at midline and endline will be used to measure CSE intervention reach, adoption, implementation and maintenance in intervention middle schools.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Peer-to-peer violence victimization

    Time frame: Baseline, Post-baseline 9 months

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

  2. Bullying

    Time frame: Baseline, Post-baseline 9 months

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

  3. Dating violence

    Time frame: Baseline, Post-baseline 9 months

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

  4. Harsh discipline in school

    Time frame: Baseline, Post-baseline 9 months

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

Secondary outcomes

  1. Sexual health confidence

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-4; higher score greater sexual health confidence

  2. Gender equality

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-4; higher score more gender equitable beliefs

  3. Attitudes about dating violence/partner violence

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-4; higher score indicates attitudes less endorsement of dating violence/partner violence

  4. Self-confidence

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-4; higher score greater self-confidence

  5. Attitudes about healthy relationships

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-4; higher score indicates attitudes that endorse healthy relationships

  6. Mental Health (Strengths and Difficulties)

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-3; higher score indicates better mental health

Other outcomes

  1. Witness partner violence in home

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-5; higher score indicates witness more intimate partner violence (IPV) at home

  2. Parental Support

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-4; higher score indicates greater parental support

  3. Harsh discipline in home

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-5; higher score indicates experiences of more harsh punishment in the home

  4. Food security

    Time frame: Baseline, Post-baseline 9 months

    Score range 1-4; higher score indicates greater food insecurity

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Projet Jeune Leader
  • United Kingdom Foreign Commonwealth Development Office

Registry information

Official study title

What Works to Prevent Violence Against Women and Girls in Madagascar: Evaluation of Projet Jeune Leaders Comprehensive Sexual Education Curriculum in Rural Middle Schools

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.