An MHH Intervention in Bangladesh Health Systems

NCT07723885 | Active Not Recruiting

• 1 other identifier: PR-24026
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Menstrual Health Intervention; Product Use Issue; Hygiene Practices and Knowledge; Menstrual Hygiene Management; Acceptability; Feasibility Study; Self-Efficacy; Quality of Life

Keywords

Cluster RCT; menstrual health; menstrual hygiene; Bangladesh health system; Reusable cloth pad; Sultana cloth pad; Sultana washer and dryer bag

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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

  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).

  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.

  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)

  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.

  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.

  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

  From enrollment to the end of intervention (12 months).

Study Arms (2)

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).

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.

Interventions

Menstrual health and hygiene intervention COMBINATION_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.

Menstrual health and hygiene intervention arm

Eligibility Criteria

• Age: 12 Years - 40 Years
• Gender Eligibility Details: Because the investigators focus on menstruating woman and girls.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Foreign Affairs, Trade and Development, Canada: collaborator
• Directorate General of Health Services, Bangladesh: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Narayanganj, Dhaka Division, Bangladesh

Location

Related Publications (15)

• Atkinson G. Cost benefit analysis and the environment: further developments and policy use. (No Title). 2018.

  BACKGROUND

• Fleischman Foreit KG, Foreit JR. Willingness to pay surveys for setting prices for reproductive health products and services: a user's manual. 2004.

  BACKGROUND

• Alberini A, Cooper J. Applications of the contingent valuation method in developing countries: A survey: Food & Agriculture Org.; 2000.

  BACKGROUND

• 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.

  PMID: 19225694 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11493324 BACKGROUND

• 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.

  PMID: 34338160 BACKGROUND

• 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.

  PMID: 35655267 BACKGROUND

• Shoemaker D. Proper procedure for sanitary napkin disposal. Cleaning and Maintenance Management. 2008;45(4):33-7.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22529538 BACKGROUND

• Bangladesh National Hygiene Baseline Survey 2014. June 2014.

  BACKGROUND

• National Mensrual Hygiene Management Strategy 2021. Policy Support Branch, Local Government Division, Ministry of Local Government, Rural Development & Co-operatives May, 2021.

  BACKGROUND

• Unicef. Guidance on menstrual health and hygiene. 2019.

  BACKGROUND

• 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.

  PMID: 23865645 BACKGROUND

Related 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 Officials

• Farhana Sultana

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: July 23, 2026
• Study Start: October 27, 2025
• Primary Completion: June 11, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)