- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06598553
What Works to Prevent Violence Against Women and Girls in Madagascar
What Works to Prevent Violence Against Women and Girls in Madagascar: Evaluation of Projet Jeune Leaders Comprehensive Sexual Education Curriculum in Rural Middle Schools
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Fiananransoa, Madagascar
- Projet Jeune Leader
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Comprehensive Sexual Education
All adolescents enrolled in intervention middle schools receive the 22 week 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.
|
|
No Intervention: Usual educational program
Usual education program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline, Post-baseline 9 months
|
|
Bullying
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-5; higher score indicates more experiences of bullying
|
Baseline, Post-baseline 9 months
|
|
Dating violence
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-5, higher score more experiences of dating violence
|
Baseline, Post-baseline 9 months
|
|
Harsh discipline in school
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-5, higher score more experiences of harsh discipline
|
Baseline, Post-baseline 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual health confidence
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-4; higher score greater sexual health confidence
|
Baseline, Post-baseline 9 months
|
|
Gender equality
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-4; higher score more gender equitable beliefs
|
Baseline, Post-baseline 9 months
|
|
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
|
Baseline, Post-baseline 9 months
|
|
Self-confidence
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-4; higher score greater self-confidence
|
Baseline, Post-baseline 9 months
|
|
Attitudes about healthy relationships
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-4; higher score indicates attitudes that endorse healthy relationships
|
Baseline, Post-baseline 9 months
|
|
Mental Health (Strengths and Difficulties)
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-3; higher score indicates better mental health
|
Baseline, Post-baseline 9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline, Post-baseline 9 months
|
|
Parental Support
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-4; higher score indicates greater parental support
|
Baseline, Post-baseline 9 months
|
|
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
|
Baseline, Post-baseline 9 months
|
|
Food security
Time Frame: Baseline, Post-baseline 9 months
|
Score range 1-4; higher score indicates greater food insecurity
|
Baseline, Post-baseline 9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nancy Glass, PhD, MPH, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00452498
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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