Acceptability of menstrual cups as a sustainable, cost-effective, and non-polluting menstrual hygiene solution for menstrual health in India

Last registered on October 04, 2021
View Trial History

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

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
March 02, 2021, 6:39 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
October 04, 2021, 3:01 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
India
Region

Primary Investigator

Name
Tanya Mahajan
Affiliation
Development Solutions Inc
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
Dr. Supriya Garikapati
PI Affiliation
University of Liverpool
Contact Investigator

Additional Trial Information

Status
Completed
Start date
2020-12-25
End date
2021-09-15
Keywords
Behavior, Health
Additional Keywords
menstrual health, informed choice, sexual and reproductive health and rights
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
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. October 04. https://doi.org/10.1257/rct.7281-2.0
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
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.
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
Supporting Documents and Materials
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
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
September 15, 2021, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
September 15, 2021, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
51 discussion groups across all three groups (12 urban mid and high income, 13 urban low income, 26 rural low income)
2 geographic clusters each in urban and rural low income contexts
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
343 menstruating girls and women covered in baseline, 310 at midline and 284 at endline
Final Sample Size (or Number of Clusters) by Treatment Arms
Baseline: 220 treatment and 110 control, Midline - 206 treatment and 104 control, Endline - 184 treatment and 100 control Treatment - Menstrual health and menstrual cup information and cup distribution and Control - Only menstrual health and cup information
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials