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Acceptability of menstrual cups as a sustainable, cost-effective, and non-polluting menstrual hygiene solution for menstrual health in India
Last registered on March 02, 2021

Pre-Trial

Trial Information
General Information
Title
Acceptability of menstrual cups as a sustainable, cost-effective, and non-polluting menstrual hygiene solution for menstrual health in India
RCT ID
AEARCTR-0007281
Initial registration date
March 02, 2021
Last updated
March 02, 2021 6:39 AM EST
Location(s)

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Primary Investigator
Affiliation
Development Solutions Inc
Other Primary Investigator(s)
PI Affiliation
University of Liverpool
Additional Trial Information
Status
On going
Start date
2020-12-25
End date
2021-09-15
Secondary IDs
Abstract
Development Solutions and University of Liverpool are conducting a research study to address the need for sustainable menstrual hygiene products and understand the acceptability of reusable menstrual cups as a non-polluting alternative among women in India. The research is in the context of increasing access and use of single-use sanitary pads with resultant waste management implications. The key objectives of this study are:

-Understanding the acceptability of menstrual cups as a solution to girls and women in India in varying contexts
-Understanding the impact of provision of information only versus the provision of menstrual cups on uptake of cups as a sustainable solution to menstrual needs of girls and women in varying contexts
-Understanding of the practical inputs on the ecosystem requirements that need to be built in for effective uptake of menstrual cups

Insights from this study will be able to generate evidence for deeper research on the acceptability of menstrual cups in different contexts and support development of regulatory and policy frameworks for safe introduction of the product in the Indian market and through Government programs addressing MHM.
External Link(s)
Registration Citation
Citation
Garikapati, Dr. Supriya and Tanya Mahajan. 2021. "Acceptability of menstrual cups as a sustainable, cost-effective, and non-polluting menstrual hygiene solution for menstrual health in India ." AEA RCT Registry. March 02. https://doi.org/10.1257/rct.7281-1.0.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The study will be conducted using a mixed methods approach among menstruating girls and women in the age group of 18-45 years from urban and rural locations in India. Participants will be randomly allocated to one of the two study conditions: (1) Participants are provided (only) information and training on use of cups (they will have to navigate market barriers to access cups) (2) Participants will receive the same training plus a menstrual cup, with the potential of voluntarily using the product. As the study objectives are to understand barriers beyond just affordability and accessibility, an enrollment ratio of 1:2 will be used. Sample size calculations indicate that a sample of 100 participants in condition (1) and 200 in condition (2) give 90% power with alpha 0.05. The focus will be on understanding the impact of the study conditions on experience of girls and women with menstrual cups – uptake of the product, ability to reuse and maintain hygiene, facilities for ensuring hygiene and any other sociocultural issues that affect the uptake of the product.
Intervention Start Date
2020-12-25
Intervention End Date
2021-09-15
Primary Outcomes
Primary Outcomes (end points)
Acceptability of menstrual cups - Proportion of women shifting from usual menstrual products to menstrual cups i.e. proportion of women using menstrual cups at end-line
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
1. Ease of using menstrual cups- Proportion of women reporting it was easy to use

2. Knowledge of using cleaning and disposing menstrual cups
2(a). Proportion of women knowing how to use & insert a cup
2(b). Proportion of women knowing how to wash a cup
2(c). Proportion of women knowing how to dispose a cup
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The study will be conducted using a mixed methods approach among menstruating girls and women in the age group of 18-45 years from urban and rural locations in India. Participants will be randomly allocated to one of the two study conditions: (1) Participants are provided (only) information and training on use of cups (they will have to navigate market barriers to access cups) (2) Participants will receive the same training plus a menstrual cup, with the potential of voluntarily using the product. As the study objectives are to understand barriers beyond just affordability and accessibility, an enrollment ratio of 1:2 will be used. Sample size calculations indicate that a sample of 100 participants in condition (1) and 200 in condition (2) give 90% power with alpha 0.05. The focus will be on understanding the impact of the study conditions on experience of girls and women with menstrual cups – uptake of the product, ability to reuse and maintain hygiene, facilities for ensuring hygiene and any other sociocultural issues that affect the uptake of the product.
Experimental Design Details
Not available
Randomization Method
Coin toss.
Randomization Unit
Discussion groups for urban mid and high income groups.
Geographic cluster randomization for low income groups in urban (Uttar Pradesh) and rural (Gujarat) contexts
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
50 discussion groups across all three groups (16 urban mid and high income, 14 urban low income, 20 rural low income)

2 geographic clusters each in urban and rural low income contexts
Sample size: planned number of observations
330 menstruating girls and women
Sample size (or number of clusters) by treatment arms
Arm1 - Inform and distribute - 220 girls and women - information on menstrual health and menstrual cups and distribution of menstrual cups
Arm 2 - Inform only - 110 girls and women - information on menstrual health and menstrual cups
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Sample of 100 participants in condition (1) and 200 in condition (2) give 90% power with alpha 0.05
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Center of Operations Research and Training Ethics Review Board
IRB Approval Date
2020-03-13
IRB Approval Number
EC-CORT/2032