An interventional study of Projet Jeune Leader Comprehensive Sexual Education in Comprehensive Sexual Education, sponsored by Johns Hopkins University. Active, not recruiting at 1 site in Madagascar. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All adolescents enrolled in intervention middle schools receive the 22 week program.
Behavioral: Projet Jeune Leader Comprehensive Sexual Education
Usual education program
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.
Peer-to-peer violence victimization
Score range 1-5; higher score indicates more experiences of peer to peer violence
Time frame: Baseline, Post-baseline 9 months
Bullying
Score range 1-5; higher score indicates more experiences of bullying
Time frame: Baseline, Post-baseline 9 months
Dating violence
Score range 1-5, higher score more experiences of dating violence
Time frame: Baseline, Post-baseline 9 months
Harsh discipline in school
Score range 1-5, higher score more experiences of harsh discipline
Time frame: Baseline, Post-baseline 9 months
Sexual health confidence
Score range 1-4; higher score greater sexual health confidence
Time frame: Baseline, Post-baseline 9 months
Gender equality
Score range 1-4; higher score more gender equitable beliefs
Time frame: Baseline, Post-baseline 9 months
Attitudes about dating violence/partner violence
Score range 1-4; higher score indicates attitudes less endorsement of dating violence/partner violence
Time frame: Baseline, Post-baseline 9 months
Self-confidence
Score range 1-4; higher score greater self-confidence
Time frame: Baseline, Post-baseline 9 months
Attitudes about healthy relationships
Score range 1-4; higher score indicates attitudes that endorse healthy relationships
Time frame: Baseline, Post-baseline 9 months
Mental Health (Strengths and Difficulties)
Score range 1-3; higher score indicates better mental health
Time frame: Baseline, Post-baseline 9 months
Witness partner violence in home
Score range 1-5; higher score indicates witness more intimate partner violence (IPV) at home
Time frame: Baseline, Post-baseline 9 months
Parental Support
Score range 1-4; higher score indicates greater parental support
Time frame: Baseline, Post-baseline 9 months
Harsh discipline in home
Score range 1-5; higher score indicates experiences of more harsh punishment in the home
Time frame: Baseline, Post-baseline 9 months
Food security
Score range 1-4; higher score indicates greater food insecurity
Time frame: Baseline, Post-baseline 9 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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