Comprehensive Sexual EducationNCT06598553
What Works to Prevent Violence Against Women and Girls in Madagascar
A study testing Projet Jeune Leader Comprehensive Sexual Education in people with Comprehensive Sexual Education, run by Johns Hopkins University at 1 site in Madagascar.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comprehensive Sexual Education
- What is being tested?
- Projet Jeune Leader Comprehensive Sexual Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 1 siteMadagascar
- Study dates
- 27 Sep 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Comprehensive Sexual Education
- Being tested
- Projet Jeune Leader Comprehensive Sexual Education
- Keywords
- sexual education, adolescents, violence prevention, health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Projet Jeune Leader Comprehensive Sexual EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Sexual Education | Experimental | All adolescents enrolled in intervention middle schools receive the 22 week program. Receives: Behavioral: Projet Jeune Leader Comprehensive Sexual Education |
| Usual educational program | No intervention | Usual education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peer-to-peer violence victimization
Score range 1-5; higher score indicates more experiences of peer to peer violence
Measured: Baseline, Post-baseline 9 months
Bullying
Score range 1-5; higher score indicates more experiences of bullying
Measured: Baseline, Post-baseline 9 months
Dating violence
Score range 1-5, higher score more experiences of dating violence
Measured: Baseline, Post-baseline 9 months
Harsh discipline in school
Score range 1-5, higher score more experiences of harsh discipline
Measured: Baseline, Post-baseline 9 months
Secondary outcomes (6)
Sexual health confidence
Score range 1-4; higher score greater sexual health confidence
Measured: Baseline, Post-baseline 9 months
Gender equality
Score range 1-4; higher score more gender equitable beliefs
Measured: 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
Measured: Baseline, Post-baseline 9 months
Self-confidence
Score range 1-4; higher score greater self-confidence
Measured: Baseline, Post-baseline 9 months
Attitudes about healthy relationships
Score range 1-4; higher score indicates attitudes that endorse healthy relationships
Measured: Baseline, Post-baseline 9 months
Mental Health (Strengths and Difficulties)
Score range 1-3; higher score indicates better mental health
Measured: Baseline, Post-baseline 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comprehensive Sexual EducationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid effectiveness-implementation trial
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Projet Jeune Leader, United Kingdom Foreign Commonwealth Development Office
- Responsible party
- Sponsor
- Investigators
- Nancy Glass, PhD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598553
- Sponsor's protocol ID
- IRB00452498
- Status last verified
- Nov 2026
- First submitted
- 15 Sep 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06598553
- Acronym / sponsor ID
- IRB00452498
- Conditions
- Comprehensive Sexual Education
- Keywords
- sexual education, adolescents, violence prevention, health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Projet Jeune Leader, United Kingdom Foreign Commonwealth Development Office
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid effectiveness-implementation trial
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Sexual Education | Experimental | Behavioral: Projet Jeune Leader Comprehensive Sexual EducationAll adolescents enrolled in intervention middle schools receive the 22 week program. |
| Usual educational program | No intervention | –Usual education program |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Projet Jeune Leader Comprehensive Sexual EducationPJL 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. | Behavioural | Comprehensive Sexual Education |
Primary outcome
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
Bullying
Time frame: Baseline, Post-baseline 9 months
Score range 1-5; higher score indicates more experiences of bullying
Dating violence
Time frame: Baseline, Post-baseline 9 months
Score range 1-5, higher score more experiences of dating violence
Harsh discipline in school
Time frame: Baseline, Post-baseline 9 months
Score range 1-5, higher score more experiences of harsh discipline
6 secondary outcomes
Sexual health confidence
Time frame: Baseline, Post-baseline 9 months
Gender equality
Time frame: Baseline, Post-baseline 9 months
Attitudes about dating violence/partner violence
Time frame: Baseline, Post-baseline 9 months
Self-confidence
Time frame: Baseline, Post-baseline 9 months
Attitudes about healthy relationships
Time frame: Baseline, Post-baseline 9 months
Mental Health (Strengths and Difficulties)
Time frame: Baseline, Post-baseline 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Comprehensive Sexual Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Glass, PhD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Projet Jeune Leader Comprehensive Sexual Education in people with Comprehensive Sexual Education, run by Johns Hopkins University at 1 site in Madagascar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Madagascar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peer-to-peer violence victimization (time frame: Baseline, Post-baseline 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.