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NCT Number: NCT07723885

An MHH Intervention in Bangladesh Health Systems

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

12 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research, Bangladesh

Narayanganj, Dhaka Division, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. 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.

  6. 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)

  7. 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.

Secondary outcomes

  1. 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.

    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.

  2. Change in school absenteeism related to menstruation using a structured self-report questionnaire

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

    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

Sponsors and collaborators

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Other

Collaborators

  • Directorate General of Health Services, Bangladesh
  • Foreign Affairs, Trade and Development, Canada

Registry information

Official study title

Cluster Randomized Controlled Trial of a Low-cost Menstrual Health and Hygiene (MHH) Intervention in the Health Systems in Bangladesh

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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