Menstrual Health InterventionNCT07723885
An MHH Intervention in Bangladesh Health Systems
A study testing Menstrual health and hygiene intervention in people with Menstrual Health Intervention and Product Use Issue, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Over 50% of Bangladeshi women and girls use old cloths as menstrual absorbents due to cost, comfort, and familiarity. A substantial proportion, comprising 52% of adolescent girls and 62% of women washed the cloths with soap and water. Read more about this study
- Who is it for?
- Ages 12 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Health Intervention, Product Use Issue, Hygiene Practices and Knowledge
- What is being tested?
- Menstrual health and hygiene intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteBangladesh
- Study dates
- 27 Oct 2025to 30 Nov 2026
- 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 12 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Narayanganj, Dhaka Division
About this study
Official title: Cluster Randomized Controlled Trial of a Low-cost Menstrual Health and Hygiene (MHH) Intervention in the Health Systems in Bangladesh
Over 50% of Bangladeshi women and girls use old cloths as menstrual absorbents due to cost, comfort, and familiarity. A substantial proportion, comprising 52% of adolescent girls and 62% of women washed the cloths with soap and water. However, more than 60% dried it in hiding instead of drying openly under the sun and over 40% of adolescent and women stored the cloths in a secret place for reuse rather than with regular clothes. Nevertheless, the minimal alternatives often necessitate the use of locally available disposable sanitary pads despite the cost. Still there are some factors which jeopardize the proper menstrual health and hygiene. These include lack of suitable sanitation facilities, availability and accessibility to affordable quality hygienic menstrual products for adolescent girls and women at home, educational institutions and at workplaces, insufficient water, sanitation facilities with proper disposal methods for used products and prevailing taboos and misconception surrounding menstruation and menstrual health hygiene. Consequently, women and girls in Bangladesh adopt unsafe and unhygienic practices to manage menstruation and face significant challenges and health problems that impact various aspects of lives. There are limited options for menstrual hygiene management. Menstrual hygiene management product which is low-cost, comfortable, easy to use and made can be the sustainable option and also align with strategic directions of national menstrual hygiene management strategy-2021. This proposal addresses lack of a proper solution for menstrual hygiene management as a barrier to a quality life for a woman. Rather than trying to shift over 50% of menstruating women and girls into an environmentally unfriendly and high-cost method of using single-use disposable pads, the investigators will develop and trial a low-cost intervention to improve MHH practices among the women and girls in Bangladesh. Improving MHH facilities at household level through the community level health systems structure can improve MHH knowledge, practice. The investigators hypothesize that the combination of the participatory BCC materials addressing social marginalization, MHH, and reproductive health, the provision of Sultana cloth pads and Sultana washer and dryer bags, and MHH Working Group meetings will increase uptake (at least 70%) and acceptability, feasibility and willingness (at least 50%) to pay for intervention products, improve knowledge, practices of menstruating women and girls in Bangladesh. The objectives are to assess the acceptability and feasibility of using Sultana cloth pad and Sultana washer and dryer bags, to assess the effect of Sultana cloth pad and Sultana washer and dryer Bags on improved MHH knowledge and practices and to measure the impact on MHH self-efficacy and quality of life. This study will be a cRCT conducting near Dhaka. There will be 331 menstruating women and adolescent girls in each arm (control and intervention). Before conducting the cRCT, first the investigators will call for a consultative meeting of the prior "MHH Working Group" that the investigators formed as part of the BMGF-funded "Piloting menstrual hygiene management interventions among urban and rural schools in Bangladesh" project, align this proposed trial objectives and hold meetings, when required, to collect the feedback and discuss the process required to achieve the targeted policy changes and to scale out the MHH interventions (Sultana cloth pad and Sultana washer and dryer bags) in the health systems. The investigators will train relevant facilitators (FWV/CHCPs) to deliver monthly sessions on puberty, MHH, and SRHR to menstruating women and adolescent girls. The investigators will conduct baseline survey to explore current MHH knowledge, practices, attitudes self-efficacy and stigma. Then in the intervention clusters, the investigators will roll out the interventions through the existing reproductive health programs in the health system and community clinics to ensure broad outreach and accessibility. In the control clusters, the investigators will not implement any strategy. The investigators will conduct monthly fidelity assessments with randomly selected participants to explore whether the Sultana cloth pad, Sultana Washer and Dryer Bag are distributed and training is provided as planned, if the participants receive the intended quantity of materials and duration of engagement, quality of delivery, participant responsiveness (level of use, understanding, and satisfaction with the intervention products), reach (proportion of intended participants who received the intervention), and differentiation (ensuring control clusters do not receive or access intervention components) and any modifications (if any or required). Then an endline survey will be conducted to assess the improved MHH knowledge, practices, attitudes, intervention uptake and reduced stigma at the end of the cRCT.
Read the 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.
- Conditions
- Menstrual Health Intervention, Product Use Issue, Hygiene Practices and Knowledge, Menstrual Hygiene Management, Acceptability, Feasibility Study
- Being tested
- Menstrual health and hygiene intervention
- Keywords
- Cluster RCT, menstrual health, menstrual hygiene, Bangladesh health system, Reusable cloth pad, Sultana cloth pad, Sultana washer and dryer bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual health and hygiene interventionCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Menstrual health and hygiene intervention arm | Active comparator | 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). Receives: Combination Product: Menstrual health and hygiene intervention |
| Control | No intervention | The control will not receive anything additional service or product from the study but they may get existing services from the government. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants reporting regular use of the Sultana cloth pad at endline
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.
Measured: From enrollment to the end of intervention (12 months) with quarterly follow-up
Acceptability of Sultana cloth pad and washer/dryer bags
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.
Measured: From enrollment to the end of intervention (12 months).
Feasibility of Sultana cloth pad and washer/dryer bags
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:
- Proportion (%) of participants reporting feasible product use.
- Proportion (%) of participants with sustained intervention uptake and continued use
Measured: From enrollment to the end of intervention (12 months).
Qualitative assessment of acceptability and feasibility
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).
Measured: After the intervention is over (after 12 months).
Willingness to pay for Sultana cloth pad and washer/dryer bags
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.
Measured: From enrollment to the end of intervention (12 months).
Change in menstrual health and hygiene knowledge using a structured knowledge questionnaire
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)
Measured: From enrollment to the end of intervention (12 months).
Change in menstrual health and hygiene practices using a structured practice questionnaire
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:
- Washing practices for reusable absorbents,
- Drying location and methods,
- Storage practices,
- Reuse practices, and
- Disposal methods for disposable absorbents. Practice indicators will be summarized as proportions of participants reporting recommended menstrual hygiene practices at baseline and endline. Changes over time and between study groups will be evaluated using effect measures including odds ratios or prevalence ratios with corresponding confidence intervals.
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.
Measured: From enrollment to the end of intervention (12 months).
Secondary outcomes (2)
Proportion of participants reporting regular use of the Sultana washer bag and Sultana dryer bag at endline.
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.
Measured: 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.
Change in school absenteeism related to menstruation using a structured self-report questionnaire
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
Measured: From enrollment to the end of intervention (12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start27 Oct 2025
- Primary completion11 Jun 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Menstrual Health InterventionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators propose a two-arm cRCT consisting of intervention and control arm. The menstruating women and girls in intervention arm will receive the Sultana Cloth Pads, Sultana Washer and Dryer Bags and the IPC session whereas the control will not receive anything.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Foreign Affairs, Trade and Development, Canada, Directorate General of Health Services, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Farhana Sultana, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723885
- Sponsor's protocol ID
- PR-24026
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19225694Demirgüneş 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.
PubMed 11493324Mahfuz 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.
PubMed 34338160Alam 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.
PubMed 35655267Shoemaker 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.
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.
PubMed 22529538Bangladesh 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.
PubMed 23865645
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Controlled Trial of a Low-cost Menstrual Health and Hygiene (MHH) Intervention in the Health Systems in Bangladesh
- ClinicalTrials.gov ID
- NCT07723885
- Acronym / sponsor ID
- PR-24026
- Conditions
- Menstrual Health Intervention, Product Use Issue, Hygiene Practices and Knowledge, Menstrual Hygiene Management, Acceptability, Feasibility Study
- Keywords
- Cluster RCT, menstrual health, menstrual hygiene, Bangladesh health system, Reusable cloth pad, Sultana cloth pad, Sultana washer and dryer bag
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Foreign Affairs, Trade and Development, Canada, Directorate General of Health Services, Bangladesh
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 23 Jul 2026 (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.
Over 50% of Bangladeshi women and girls use old cloths as menstrual absorbents due to cost, comfort, and familiarity. A substantial proportion, comprising 52% of adolescent girls and 62% of women washed the cloths with soap and water. However, more than 60% dried it in hiding instead of drying openly under the sun and over 40% of adolescent and women stored the cloths in a secret place for reuse rather than with regular clothes. Nevertheless, the minimal alternatives often necessitate the use of locally available disposable sanitary pads despite the cost. Still there are some factors which jeopardize the proper menstrual health and hygiene. These include lack of suitable sanitation facilities, availability and accessibility to affordable quality hygienic menstrual products for adolescent girls and women at home, educational institutions and at workplaces, insufficient water, sanitation facilities with proper disposal methods for used products and prevailing taboos and misconception surrounding menstruation and menstrual health hygiene. Consequently, women and girls in Bangladesh adopt unsafe and unhygienic practices to manage menstruation and face significant challenges and health problems that impact various aspects of lives. There are limited options for menstrual hygiene management. Menstrual hygiene management product which is low-cost, comfortable, easy to use and made can be the sustainable option and also align with strategic directions of national menstrual hygiene management strategy-2021. This proposal addresses lack of a proper solution for menstrual hygiene management as a barrier to a quality life for a woman. Rather than trying to shift over 50% of menstruating women and girls into an environmentally unfriendly and high-cost method of using single-use disposable pads, the investigators will develop and trial a low-cost intervention to improve MHH practices among the women and girls in Bangladesh. Improving MHH facilities at household level through the community level health systems structure can improve MHH knowledge, practice. The investigators hypothesize that the combination of the participatory BCC materials addressing social marginalization, MHH, and reproductive health, the provision of Sultana cloth pads and Sultana washer and dryer bags, and MHH Working Group meetings will increase uptake (at least 70%) and acceptability, feasibility and willingness (at least 50%) to pay for intervention products, improve knowledge, practices of menstruating women and girls in Bangladesh. The objectives are to assess the acceptability and feasibility of using Sultana cloth pad and Sultana washer and dryer bags, to assess the effect of Sultana cloth pad and Sultana washer and dryer Bags on improved MHH knowledge and practices and to measure the impact on MHH self-efficacy and quality of life. This study will be a cRCT conducting near Dhaka. There will be 331 menstruating women and adolescent girls in each arm (control and intervention). Before conducting the cRCT, first the investigators will call for a consultative meeting of the prior "MHH Working Group" that the investigators formed as part of the BMGF-funded "Piloting menstrual hygiene management interventions among urban and rural schools in Bangladesh" project, align this proposed trial objectives and hold meetings, when required, to collect the feedback and discuss the process required to achieve the targeted policy changes and to scale out the MHH interventions (Sultana cloth pad and Sultana washer and dryer bags) in the health systems. The investigators will train relevant facilitators (FWV/CHCPs) to deliver monthly sessions on puberty, MHH, and SRHR to menstruating women and adolescent girls. The investigators will conduct baseline survey to explore current MHH knowledge, practices, attitudes self-efficacy and stigma. Then in the intervention clusters, the investigators will roll out the interventions through the existing reproductive health programs in the health system and community clinics to ensure broad outreach and accessibility. In the control clusters, the investigators will not implement any strategy. The investigators will conduct monthly fidelity assessments with randomly selected participants to explore whether the Sultana cloth pad, Sultana Washer and Dryer Bag are distributed and training is provided as planned, if the participants receive the intended quantity of materials and duration of engagement, quality of delivery, participant responsiveness (level of use, understanding, and satisfaction with the intervention products), reach (proportion of intended participants who received the intervention), and differentiation (ensuring control clusters do not receive or access intervention components) and any modifications (if any or required). Then an endline survey will be conducted to assess the improved MHH knowledge, practices, attitudes, intervention uptake and reduced stigma at the end of the cRCT.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators propose a two-arm cRCT consisting of intervention and control arm. The menstruating women and girls in intervention arm will receive the Sultana Cloth Pads, Sultana Washer and Dryer Bags and the IPC session whereas the control will not receive anything.
| Arm | Type | Receives |
|---|---|---|
| Menstrual health and hygiene intervention arm | Active comparator | Combination Product: Menstrual health and hygiene interventionIn 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). |
| Control | No intervention | –The control will not receive anything additional service or product from the study but they may get existing services from the government. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Menstrual health and hygiene interventionThe 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. | Combination product | Menstrual health and hygiene intervention arm |
Primary outcome
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
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.
Acceptability of Sultana cloth pad and washer/dryer bags
Time frame: From enrollment to the end of intervention (12 months).
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.
Feasibility of Sultana cloth pad and washer/dryer bags
Time frame: From enrollment to the end of intervention (12 months).
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: * Proportion (%) of participants reporting feasible product use. * Proportion (%) of participants with sustained intervention uptake and continued use
Qualitative assessment of acceptability and feasibility
Time frame: After the intervention is over (after 12 months).
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).
Willingness to pay for Sultana cloth pad and washer/dryer bags
Time frame: From enrollment to the end of intervention (12 months).
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.
Change in menstrual health and hygiene knowledge using a structured knowledge questionnaire
Time frame: From enrollment to the end of intervention (12 months).
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)
Change in menstrual health and hygiene practices using a structured practice questionnaire
Time frame: From enrollment to the end of intervention (12 months).
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: * Washing practices for reusable absorbents, * Drying location and methods, * Storage practices, * Reuse practices, and * Disposal methods for disposable absorbents. Practice indicators will be summarized as proportions of participants reporting recommended menstrual hygiene practices at baseline and endline. Changes over time and between study groups will be evaluated using effect measures including odds ratios or prevalence ratios with corresponding confidence intervals. 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.
2 secondary outcomes
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.
Change in school absenteeism related to menstruation using a structured self-report questionnaire
Time frame: From enrollment to the end of intervention (12 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 23 Jul 2026.
- BackgroundAtkinson G. Cost benefit analysis and the environment: further developments and policy use. (No Title). 2018.
- BackgroundFleischman Foreit KG, Foreit JR. Willingness to pay surveys for setting prices for reproductive health products and services: a user's manual. 2004.
- BackgroundAlberini A, Cooper J. Applications of the contingent valuation method in developing countries: A survey: Food & Agriculture Org.; 2000.
- Background: PubMed 19225694Mould 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.
- BackgroundDemirgüneş 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.
- Background: PubMed 11493324Donaldson 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.
- Background: PubMed 34338160Mahfuz 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.
- Background: PubMed 35655267Alam 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.
- BackgroundShoemaker D. Proper procedure for sanitary napkin disposal. Cleaning and Maintenance Management. 2008;45(4):33-7.
- BackgroundHouse 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.
- Background: PubMed 22529538Balamurugan 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.
- BackgroundBangladesh National Hygiene Baseline Survey 2014. June 2014.
- Overcoming the taboo: advancing the global agenda for menstrual hygiene management for schoolgirls. American journal of public healthLink provided by the sponsor.
- Guidance on menstrual health and hygieneLink provided by the sponsor.
- Community-based study of reproductive tract infections among women of the reproductive age group in the urban health training centre area in Hubli, KarnatakaLink provided by the sponsor.
- Menstrual hygiene matters: a resource for improving menstrual hygiene around the worldLink provided by the sponsor.
- Proper procedure for sanitary napkin disposal. Cleaning and Maintenance ManagementLink provided by the sponsor.
- Evaluation of a menstrual hygiene intervention in urban and rural schools in Bangladesh: a pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Farhana Sultana principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menstrual health and hygiene intervention in people with Menstrual Health Intervention and Product Use Issue, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 4 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 23 Jul 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 Bangladesh. 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?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07723885, which also lists 15 linked publications.
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 23 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.