- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07723885
An MHH Intervention in Bangladesh Health Systems
Cluster Randomized Controlled Trial of a Low-cost Menstrual Health and Hygiene (MHH) Intervention in the Health Systems in Bangladesh
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Menstrual health and hygiene (MHH) implies the prerequisites of individuals who experience menstruation, especially a secure and accessible means of obtaining the knowledge, resources, and facilities. These are crucial for dealing with the periods in a dignified and comfortable manner, as well as the systemic components that relate menstruation to health, gender equality, empowerment, and other domains.
Bangladesh has achieved remarkable success in improving water and sanitation coverage. It has earned global accolades to attain coverage despite poverty and limited resources. However, improvement in hygiene still lags and has immense scope for improvement. This is more specifically true for MHH, as evident by pertinent data: the only 53% of students at schools have sufficient information about menstruation before reaching menarche; 30% of girl students miss school during menstruation and 34% of girls in school use old cloth for MHM. Moreover, many girls are unaware of the hygienic and proper use of cloth or reusable pads. Still, most of the girls prefer drying and storing the menstrual cloth in hiding and only 21% dry it under the sun. Same report showed that use of disposable pads depended on economic status. Consequently, women and girls often adopt the convenient menstrual management practices that are unhygienic and directly affect the likelihood of reproductive tract infections (RTIs) and urinary tract infections (UTIs). MHH interventions often promote the use of disposable pads due to the difficulties of maintaining reusable menstrual absorbents properly. Discarded menstrual absorbents generate enormous amounts of waste to the annual waste system. There is no proper procedure for biodegradable sanitary pad disposal. Sanitary pads are frequently thrown into slums' common latrines and toilets, which are close to and connected to ponds or reservoirs of stagnant water. Sanitary pad disposal like that often clogs latrines.
Rather than shifting majority of women and girls from the preferred choice of menstrual absorbent, the investigators tried to add a different dimension to it. As a result, a low-cost MHH innovations and intervention approaches were developed and tested through the studies conducted in schools, slums and readymade garment (RMG) factories.
The innovations included 1) Products: Sultana cloth pad with underwear and waterproof storage bag (to take the stained cloth back home for washing and drying); 2) Education: behavior change communication (BCC) materials including pictorial flipchart, cue card on puberty and menstruation and associated manuals; 3) Maintenance: Sultana washer and dryer bags; and 4) MHH Working Group consisting government and non-government stakeholders working on MHH issues towards policy improvements. These innovations demonstrated 34% to 76% of uptake among both women and girls, improvement of knowledge and practices and decreased absenteeism by 1% in the RMGs and 8% in schools.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dhaka Division
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Narayanganj, Dhaka Division, Bangladesh
- International Centre for Diarrhoeal Disease Research, Bangladesh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Upazila and community clinics located in Dhaka division
- Households with at least one menstruating adolescent girl and one menstruating woman
- Menstruating women and girls residing in the selected households (married or unmarried)
- Availability of local tailors working within the community
Exclusion Criteria:
- Intention to migrate or relocate from the study area within the next year
- Unwillingness to participate in the trial
- Inability to provide informed consent
- Refusal of consent by a parent or legal guardian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Menstrual health and hygiene intervention arm
In the intervention arm, each menstruating women and girl will receive multicomponent intervention: Sultana cloth pads+ Sultana washer and dryer bags+ BCC. 1) Products: each menstruating woman and girl will receive 5 pieces of Sultana cloth pad, associated user manual, one underwear and one waterproof storage bag; 2) Education: each woman and girl will receive inter-personal communication (IPC) sessions conducted by FWV/CHCPs using training manuals and BCC materials; 3) Maintenance: each woman and girl will receive one Sultana washer and dryer bags and associated user manual to ease the hygienic maintenance of the pad (Please see figure 5 in the attached protocol).
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The multicomponent intervention includes: 1.
The Sultana Cloth Pad (Patent no.
1006795) is a simple innovation made with locally available flannel cloth on the outside.
Poly-micro fabric as an absorbent attached to the top as a water-proof barrier layer.
Women and girls fold it to use as a menstrual absorbent.
Waterproof storage bag to store/take the stained cloth pad back to home for washing/drying.
2. The BCC materials comprised four modules: 1) growing up 2) reproductive systems 3) menstruation and 4) nutrition.
3. The Sultana Washer Bag (Patent application no.
P/BD/2024/000154) is made out of waterproof, polyester fabric with a scrubbing pad attached to the inner part of the bag to scrub the menstrual cloths.
The bag can be sealed with a strap at one end while washing and drain the water afterward.
The Sultana Dryer Bag (Patent application no.
P/BD/2024/000153) is made of mesh and is rectangular.
It is black in color to maximize the amount of sunshine it can absorb.
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No Intervention: Control
The control will not receive anything additional service or product from the study but they may get existing services from the government.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of participants reporting regular use of the Sultana cloth pad at endline
Time Frame: From enrollment to the end of intervention (12 months) with quarterly follow-up
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Proportion of participants reporting regular use of the Sultana cloth pad and replacement of cloth/rags by endline will be assessed using a structured product-use questionnaire, product-use checklist and observational assessment checklist developed for this study.
The questionnaire will assess cloth pad use during menstruation, frequency of use and continued use across follow-up visits.
Trained data collectors will conduct household observations to verify product availability, storage condition and visible signs of product use, where applicable.
Regular use will be defined as self-reported use of cloth pad during menstruation for at least two consecutive menstrual cycles, with observational verification.
These items will be combined to derive one aggregated primary outcome: the proportion (%) of participants meeting the definition of regular use at endline.
The primary analysis will compare this proportion between arms using mixed-effects regression models accounting for clustering.
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From enrollment to the end of intervention (12 months) with quarterly follow-up
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Acceptability of Sultana cloth pad and washer/dryer bags
Time Frame: From enrollment to the end of intervention (12 months).
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Acceptability will be assessed through participant-reported measures of comfort, ease of use, convenience, overall liking, and satisfaction with the Sultana cloth pad and washer/dryer bags. Responses will include categorical items (yes/no and multiple-choice questions) and Likert-scale satisfaction ratings. Participants reporting a satisfaction rating of "satisfied" or higher, along with continued product use, will be considered to demonstrate product acceptability. Measurement tool: Structured acceptability questionnaire adapted from previous menstrual health product evaluation tools. Outcome measure: Proportion (%) of participants reporting acceptable product satisfaction. |
From enrollment to the end of intervention (12 months).
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Feasibility of Sultana cloth pad and washer/dryer bags
Time Frame: From enrollment to the end of intervention (12 months).
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Feasibility will be assessed through participant-reported measures of ease of washing, drying, storage, durability, daily practicality, water availability, and privacy for product use and maintenance. Feasibility will also be evaluated through sustained intervention uptake and continued product use during the intervention period. Measurement tool: Structured feasibility questionnaire adapted from menstrual health product implementation assessment tools. Outcome measures:
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From enrollment to the end of intervention (12 months).
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Qualitative assessment of acceptability and feasibility
Time Frame: After the intervention is over (after 12 months).
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Qualitative interviews with participants, community healthcare providers, and family welfare visitors will explore perceived acceptability, usability, and feasibility of integrating the intervention into daily menstrual practices and routine menstrual health services. Data will be analyzed thematically to complement and triangulate quantitative findings. User and non-user analysis will explore the benefits and recommendations to improve the intervention. Measurement tool: In-depth interviews (IDIs) with users and non-users of the Sultana cloth pad and washer and dryer bags and key informant interviews (KIIs). |
After the intervention is over (after 12 months).
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Willingness to pay for Sultana cloth pad and washer/dryer bags
Time Frame: From enrollment to the end of intervention (12 months).
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Willingness to pay will be assessed using a structured questionnaire. Willingness to pay is defined as a positive response to a binary purchase-intention question (yes/no) combined with a non-zero stated maximum amount participants are willing to pay for the intervention products. The single reported value is the proportion of participants meeting both criteria. Measurement Tool: Structured willingness-to-pay questionnaire. Outcome measure: Proportion (%) of participants expressing willingness to pay for the products. |
From enrollment to the end of intervention (12 months).
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Change in menstrual health and hygiene knowledge using a structured knowledge questionnaire
Time Frame: From enrollment to the end of intervention (12 months).
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Knowledge on menstrual health and hygiene will be assessed using a 5-item structured questionnaire consisting of multiple-choice and true/false questions addressing menstrual cycle understanding, menstrual hygiene practices, and key menstrual health concepts. Each correct response will be assigned 1 point and incorrect responses will receive 0 points. A composite knowledge score will be calculated by summing all correct responses. Total scores range from 0 to 5, with higher scores indicating better menstrual health and hygiene knowledge. Change in knowledge will be assessed by comparing participant scores between baseline and endline. Measurement tool: 5-item structured menstrual health and hygiene knowledge questionnaire. Outcome measure: Change in menstrual health and hygiene knowledge score from baseline to endline. Unit of measure: Score (range: 0-5) |
From enrollment to the end of intervention (12 months).
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Change in menstrual health and hygiene practices using a structured practice questionnaire
Time Frame: From enrollment to the end of intervention (12 months).
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Menstrual hygiene practices will be assessed using a self-reported structured questionnaire containing multiple closed-ended questions on menstrual absorbent washing, drying, storage, reuse, and disposal practices. The questionnaire will assess behaviors related to:
Measurement Tool: Structured menstrual health and hygiene practices questionnaire. Outcome measure: Change in proportion (%) of participants reporting recommended menstrual health and hygiene practices from baseline to endline. |
From enrollment to the end of intervention (12 months).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of participants reporting regular use of the Sultana washer bag and Sultana dryer bag at endline.
Time Frame: From enrollment to the end of intervention, assessed over 12 months with quarterly follow-up assessments and regular use status will be reported at endline.
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Use of the Sultana washer and dryer bags will be assessed using a structured questionnaire and observational assessment checklist.
Assessment items will include self-reported use during menstruation-related washing and drying, frequency of use, and product availability and visible signs of use where applicable.
These items will be combined to derive one aggregated outcome: the proportion (%) of participants meeting the predefined definition of regular Sultana washer and dryer bag use at endline.
Although use will be monitored during quarterly follow-up assessments, this outcome will not be analyzed as time to first use or time to regular use.
Secondary analyses will compare the proportion meeting the definition of regular use between intervention and control arms at endline, using regression models accounting for clustering.
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From enrollment to the end of intervention, assessed over 12 months with quarterly follow-up assessments and regular use status will be reported at endline.
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Change in school absenteeism related to menstruation using a structured self-report questionnaire
Time Frame: From enrollment to the end of intervention (12 months).
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School absenteeism related to menstruation will be assessed using a structured self-reported questionnaire in which participants report the number of school days missed due to menstruation during the previous three months. Change in absenteeism will be measured by comparing the number of school days missed between baseline and endline assessments. Measurement tool: Structured self-reported school absenteeism questionnaire Outcome measure: Change in number of school days missed due to menstruation from baseline to endline. Unit of measure: Number of days |
From enrollment to the end of intervention (12 months).
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Farhana Sultana, International Centre for Diarrhoeal Disease Research, Bangladesh
Publications and helpful links
General Publications
- Balamurugan SS, Bendigeri N. Community-based study of reproductive tract infections among women of the reproductive age group in the urban health training centre area in hubli, karnataka. Indian J Community Med. 2012 Jan;37(1):34-8. doi: 10.4103/0970-0218.94020.
- Atkinson G. Cost benefit analysis and the environment: further developments and policy use. (No Title). 2018.
- Fleischman Foreit KG, Foreit JR. Willingness to pay surveys for setting prices for reproductive health products and services: a user's manual. 2004.
- Alberini A, Cooper J. Applications of the contingent valuation method in developing countries: A survey: Food & Agriculture Org.; 2000.
- Mould Quevedo JF, Contreras Hernandez I, Garduno Espinosa J, Salinas Escudero G. [The willingness-to-pay concept in question]. Rev Saude Publica. 2009 Apr;43(2):352-8. doi: 10.1590/s0034-89102009005000007. Epub 2009 Feb 13. Spanish.
- Demirgüneş BK. Relative importance of perceived value, satisfaction and perceived risk on willingness to pay more. International Review of Management and Marketing. 2015;5(4):211-20.
- Donaldson C. Eliciting patients' values by use of 'willingness to pay': letting the theory drive the method. Health Expect. 2001 Sep;4(3):180-8. doi: 10.1046/j.1369-6513.2001.00126.x.
- Mahfuz MT, Sultana F, Hunter EC, Jahan F, Akand F, Khan S, Mobashhara M, Rahman M, Alam MU, Unicomb L, Luby SP, Winch PJ. Teachers' perspective on implementation of menstrual hygiene management and puberty education in a pilot study in Bangladeshi schools. Glob Health Action. 2021 Jan 1;14(1):1955492. doi: 10.1080/16549716.2021.1955492.
- Alam MU, Sultana F, Hunter EC, Winch PJ, Unicomb L, Sarker S, Mahfuz MT, Al-Masud A, Rahman M, Luby SP. Evaluation of a menstrual hygiene intervention in urban and rural schools in Bangladesh: a pilot study. BMC Public Health. 2022 Jun 2;22(1):1100. doi: 10.1186/s12889-022-13478-1.
- Shoemaker D. Proper procedure for sanitary napkin disposal. Cleaning and Maintenance Management. 2008;45(4):33-7.
- House S, Mahon T, Cavill S. Menstrual hygiene matters: a resource for improving menstrual hygiene around the world. Reproductive Health Matters. 2013 May 1;21(41):257-9.
- Bangladesh National Hygiene Baseline Survey 2014. June 2014.
- National Mensrual Hygiene Management Strategy 2021. Policy Support Branch, Local Government Division, Ministry of Local Government, Rural Development & Co-operatives May, 2021.
- Unicef. Guidance on menstrual health and hygiene. 2019.
- Sommer M, Sahin M. Overcoming the taboo: advancing the global agenda for menstrual hygiene management for schoolgirls. Am J Public Health. 2013 Sep;103(9):1556-9. doi: 10.2105/AJPH.2013.301374. Epub 2013 Jul 18. No abstract available.
Helpful Links
- Overcoming the taboo: advancing the global agenda for menstrual hygiene management for schoolgirls. American journal of public health
- Guidance on menstrual health and hygiene
- Community-based study of reproductive tract infections among women of the reproductive age group in the urban health training centre area in Hubli, Karnataka
- Menstrual hygiene matters: a resource for improving menstrual hygiene around the world
- Proper procedure for sanitary napkin disposal. Cleaning and Maintenance Management
- Evaluation of a menstrual hygiene intervention in urban and rural schools in Bangladesh: a pilot study
- Eliciting patients' values by use of 'willingness to pay': letting the theory drive the method
- Relative importance of perceived value, satisfaction and perceived risk on willingness to pay more
- The willingness-to-pay concept in question
- Applications of the contingent valuation method in developing countries: A survey
- Willingness to pay surveys for setting prices for reproductive health products and services: a user's manual
- Cost benefit analysis and the environment: further developments and policy use
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Keywords
Other Study ID Numbers
- PR-24026
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
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