|
Field
Abstract
|
Before
Background: Around the time of menarche, the gap in academic achievement and psychosocial health between girls and boys in low and middle income countries substantially widens to the detriment of girls. This seems to be partially caused by girls’ poor ability to practice Menstrual Health Management (MHM). Poor MHM is also a challenge in Bangladesh, where 40% of girls reportedly miss three days of school during their menstrual period. We conduct a cluster randomized controlled trial of the impact of a complex intervention facilitating MHM in Bangladesh: the Ritu RCT study.
Methods: 150 Schools were randomized into three groups: i) receiving the basic school program ; ii) the basic school program and parent training; iii) a control group. The primary beneficiaries are schoolgirls. The program will last for 3 years, and the primary outcomes are academic attainment and psychosocial outcomes. Secondary outcomes include MHM knowledge, attitudes and practices, mobility, child marriage and teenage pregnancy. We will analyze both the short-term and long-term effects of both treatment arms on our primary and secondary outcomes. In addition, we will conduct cost-effectiveness evaluations of both treatment arms and a process evaluation of the entire intervention.
Discussion: Even though MHM programs are popular, there is very limited evidence on such programs. It is troubling that it is unclear what works, why, and at what cost. We aim to reduce these knowledge gaps by providing rigorous evidence. Different to most evaluations of public health programs, we evaluate a complex intervention and will include cost-effectiveness analysis for both treatment arms.
|
After
Background: Many girls in developing countries get their first menstrual period without knowing what it is, leaving them scared and ill-informed about practicing Menstrual Health (MH). Girls’ poor ability to manage MH plays a role in the barriers to education, and general wellbeing. This paper presents the protocol for a cluster randomized controlled trial on the impact of a complex intervention facilitating MH in Bangladesh: the Ritu trial.
Methods/Design: We randomized 149 schools from one rural district, into three groups; i) receiving a school program (sanitation facilities, teacher trainings and MH module for school curriculum); ii) a school program and a household program (parental education and MH visual booklet); iii) a control group. The primary beneficiaries are schoolgirls in grades 6 until 8, age 11-15. The program will last for 3 years, and the primary outcomes are education outcomes, psychosocial outcomes and empowerment of adolescent girls. We will make use of administrative data, experimental data and survey data. School data of all pupils is collected throughout; additionally, a subsample of 4,172 girls partakes in surveys; Survey data collection took place at baseline (2017), and planned at midline (2019) and endline (2021). We will analyse both the short-term and long-term effects of both treatment arms in addition to cost-effectiveness evaluations and a process evaluation.
Discussion: Even though MH programs are becoming more popular, there is very limited evidence on the measurement of key outcomes and the impact of such programs. We aim to reduce these knowledge gaps and to provide policy lessons for future implementers or policymakers.
|
|
Field
Last Published
|
Before
December 06, 2017 10:56 AM
|
After
May 31, 2019 02:58 PM
|
|
Field
Intervention (Public)
|
Before
We randomized schools into different groups: both groups receive the school level intervention, but treatment arm II also receives a household intervention.
The school-level intervention consists of three components:
1) Program launch at schools with a campaign to familiarize students, teachers and school management with the Ritu program.
2) MHM-friendly toilet facilities are realized at schools.
3) An MHM module is added to the school curriculum and teachers and headmasters receive training on how to integrate the module in their lesson plans.
Treatment arm II: school- and household-level intervention
Next to the school-level treatment, the parents of girls in this treatment receive a household level intervention consisting of two components:
1) Parent sessions are provided to fathers and mothers separately in their village. These parents session cover topics on MHM knowledge, attitudes, and practices and ways to support their daughters.
2) A module with visual information on basic MHM is given to girls to take home to increase household members’ knowledge, support and dialogue.
|
After
see pre analysis plan
|
|
Field
Primary Outcomes (End Points)
|
Before
School attendance, school performance, empowerment, happiness, physical outcomes, Menstrual Health Management
|
After
Educational outcomes, psychosocial outcomes, empowerment
|
|
Field
Primary Outcomes (Explanation)
|
Before
School attendance is constructed both by using administrative records as well as our own data collection, and survey questions.
School performance is constructed by administrative records, and survey questions.
Empowerment is constructed on survey questions (including the empowerment tool from OPHI - Oxford Poverty and Human Development Initiative.
Happiness is based on a survey question
Physical outcomes are constructed with survey data on eg. rash incidence, depressive feelings, irritations
MHM is contructed by using survey data on MHM knowledge, attitudes and practices
|
After
see pre analysis plan
|
|
Field
Experimental Design (Public)
|
Before
We conduct a cluster randomized control trial with 150 schools that were randomized into three groups: i) receiving the basic school program; ii) the basic school program and household program iii) a control group. All pupils in grades 6 to 8 (age 11-15) are automatically enrolled in the program and we collect school-attainment and survey data on a subset of girls. We conducted a baseline survey in January 2017, and continuously collect data on school attendance in two different ways: by primary data collection and administrative school records.
|
After
see pre analysis plan
|
|
Field
Randomization Method
|
Before
The randomization was done in office, on a computer with the STATA14 program in January 2017.
We randomized schools (i.e. the clusters) into one of the two treatment arms or the control group, stratified by 3 variables:
- Administrative attendance records, (low / high);
- Region (7 Upazillas); there are small difference in Upazilla-wise governance structures and size of schools.
- Quality-quantity of toilets (low / high); data collected by our implementing partner.
The first covariate reflects a primary outcome, and the latter two covariates are potentially important predictors of our primary outcomes.
|
After
see pre analysis plan
|
|
Field
Planned Number of Observations
|
Before
30,021 female students
|
After
see pre analysis plan
|
|
Field
Power calculation: Minimum Detectable Effect Size for Main Outcomes
|
Before
As the number of clusters (i.e. schools) we could use was limited to a maximum of 150 at the onset of the study, we performed calculations to estimate the number of schoolgirls we would need to sample per school for our survey. We did this using a mapping study conducted in 8 schools in the Netrokona district. We performed separate a sample size calculations for our primary outcomes using the open-source software program Optimal Design (3.01). We specified the following parameters: repeated measures with 3 data collection rounds, taking the 3-level nature of the data into account (Level 1: schoolgirls; Level 2: schoolgirls clustered into time (baseline, midline, endline); Level 3: schoolgirls clustered into time are clustered into schools), an alpha of 0.05, and ran different scenarios with the following options: an expected effect size of 0.2 or 0.3 and an ICC of 0.1 or 0.3. These calculations indicated that we would need to sample of at least 25 schoolgirls per school to be powered at 0.8 for all primary outcome measures included in the survey.
|
After
see pre analysis plan
|
|
Field
Additional Keyword(s)
|
Before
Gender, Menstrual Health, cost-effectiveness
|
After
Menstrual Health, Schools, Norms, Impact, RCT
|
|
Field
Keyword(s)
|
Before
Education, Health, Welfare
|
After
Education, Gender, Health, Welfare
|
|
Field
Intervention (Hidden)
|
Before
Elaborate intervention description Treatment arm I: school-level intervention
The school-level intervention consists of:
1) MHM-friendly toilet facilities are realized at intervention schools via budget tracking. This is a process through which school management is activated to claim the water and sanitation budget available at the local government. The NGO meets with the school management committees, school girls and boys and community members to create ownership of the problem and make a claim on this budget and track progress. All facilities will be prepared to meet girls’ physical and psychosocial needs, such as privacy, ability to clean the body and clean or change absorbents. There will be gender-separate toilets with light and a lock, running water and disposal facilities.
2) A school campaign is organized at every intervention school to familiarize students, teachers and school management with the Ritu project. The NGO visits schools to facilitate a discussion and essay writing competition, distribute project flyers, present the Ritu project activities and show an episode of the TV reality show developed for the project.
3) An extensive Menstrual Health and puberty module was developed. This module aims at improving students knowledge of MH related topics (such as knowledge of cycle length and requirements for hygiene) as well as increasing attitudes of acceptance of menstruation as a normal physiological process and the awareness of the importance of having to manage this process. This module will be integrated with the existing modules. In grades 6 to 8, information on MH and puberty, although minimal, is already included in the National Curriculum. In a 3-day training, teachers and the headmaster from every intervention school receive training on the module. Designated teachers (subjects physical education and home economics) develop a lesson plan to makes sure that MH is taught more often and more intensely than the pre-intervention modules. The headmaster and remaining teachers can more easily support the designated teachers and create an MH-friendly environment within the schools.
Treatment arm II: school- and household-level intervention
The household level intervention consists of:
1) Parallel with teacher training, parent sessions are provided to fathers and mothers separately. The sessions, aim to increase parent’s knowledge of MH, as well as trying to promote adaptation of girl-friendly norms related to menstruation. There will be separate sessions for fathers and mothers.
2) In the parent sessions, a WASH awareness program supports parents to claim budget at the local government to improve MHM-friendly WASH facilities at home. A mapping exercise ensures improvements are done where they are most needed.
3) A module with visual information on basic MH is given to girl students to take home to increase household members’ knowledge, support and dialogue. The module presents easy to read messages and visuals about what happens and what is needed during a menstrual period.
|
After
see pre analysis plan
|
|
Field
Secondary Outcomes (End Points)
|
Before
Demographics,
Household poverty rate (Poverty Probability Index)
Process evaluation measures
|
After
Menstrual Health, Support for restrictive menstrual norms, physical health during menstruation, menstrual health support at school, sexual and reproductive health
|