‘What’s the bleeding problem?’ Menstrual health policy and consequential attitudes in India

Last registered on January 07, 2022

Pre-Trial

Trial Information

General Information

Title
‘What’s the bleeding problem?’ Menstrual health policy and consequential attitudes in India
RCT ID
AEARCTR-0008767
Initial registration date
January 05, 2022

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
January 07, 2022, 7:13 PM EST

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

Locations

Region

Primary Investigator

Affiliation
University of Liverpool

Other Primary Investigator(s)

PI Affiliation
Liverpool School of Tropical Medicine

Additional Trial Information

Status
Completed
Start date
2017-07-10
End date
2018-05-25
Secondary IDs
Safa0317R; RETH000734
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
In a bid to improve menstrual health outcomes in LMICs, state policies and civic society have determinedly promoted the take up of disposable pads, at the neglect of less polluting sustainable and cheaper alternatives. This oversight is problematic as it contributes to the increased burden of waste management, and denies women the right to informed choice. Using an experimental approach, this study seeks to examine the effects of exposure to sustainable alternatives compared with disposable pads on women’s attitudes to menstrual materials and practices. We test the hypothesis that such exposure positively effects women’s preferences and attitudes to more sustainable alternatives versus disposable pads.

The study will be conducted across 10 sites in the city of Hyderabad, Telangana with the help of 2 facilitating grass-roots NGOs (Safa and KGNMT). We will use a community participation methodology that carefully considers the cultural context and policy backdrop in which decisions on menstrual products and practices are made.

The basic design is to recruit 500 women (50 from each site) and randomly allocate them to one of the three conditions using the ration 1:2:2: information only (C1); information + reusable material (C2); information + disposable pad (C3). After baseline survey, we will provide each of the three conditions with information on menstrual hygiene and alternative materials. Those in C2 and C3 will be provided with relevant menstrual material sufficient for 6 months of use. End line will be carried out after 6 months. At both baseline and end line we will collect information on various menstrual outcomes including knowledge; preferred material; menstrual practices (access, use and disposal). Primary outcome will be preference, with secondary outcomes being knowledge and attitudes to use and disposal.
External Link(s)

Registration Citation

Citation
Garikipati, Supriya and Penelope Phillips-Howard . 2022. "‘What’s the bleeding problem?’ Menstrual health policy and consequential attitudes in India." AEA RCT Registry. January 07. https://doi.org/10.1257/rct.8767
Experimental Details

Interventions

Intervention(s)
There were three study conditions: (1) Disposable arm provided with disposable pads and complete information on the full range of menstrual alternatives, their hygienic use and correct disposal; (2) Reusable arm was given cloth-pads and information on menstrual products; and (3) Inform-only arm, continued with usual practice and received same information. The current study analyses the time points directly before for all conditions (baseline), and after the women completed six months of product use (follow-up). Follow-up is used for comparisons between disposable pads to reusable cloth-pads to inform-only.

All study participants received complete information on the entire range of menstrual alternatives along with their hygienic use and correct disposal. For the two product conditions, participants also received sufficient menstrual products for six months. To achieve community acceptance, the products used in the trial had to be selected carefully and with the involvement of the NGOs. A careful selection exercise was undertaken which assessed two products as viable for the community trial: a pad that required burial to compost (‘Disposable’ condition) and a reusable cloth-pad with an anti-microbial top layer (‘Reusable’ condition). The selection process and additional information about the products are detailed in in Appendix A, Box A2.
This gave us the three study arms: information + disposable pad (Disposable condition); information + reusable cloth-pad (Reusable condition); and information only + usual practice (Inform-only condition). After allocation to study conditions, baseline was completed, and menstrual materials distributed to Disposable and Reusable arms. All interactions were administered by pairs of women, one of whom was an employee of the partner NGOs. Most individual interviews were carried out in respondent’s home, but where women preferred it, these were done in partner NGOs’ office.
Intervention Start Date
2017-09-18
Intervention End Date
2017-10-27

Primary Outcomes

Primary Outcomes (end points)
The primary outcome is a measure of women’s preference for reusable menstrual products. This outcome measure was chosen as the main aim of the study to understand the effect of exposing women to alternatives to disposable pads on their preference for menstrual products.
Primary Outcomes (explanation)
Preference for sustainable menstrual absorbents: We developed this outcome using women’s response to the following question: “Can you please tell us what menstrual material you prefer most? In answering this question, please think only of your preference and not of other factors like price and availability. You can choose a single menstrual material or if you like, you can choose a combination of materials you prefer”. Women who chose a reusable or compostable material (like, homemade cloth-pad; commercial cloth-pad; menstrual cup; compostable pad) received two points, those who chose sustainable products in combination with disposables (like, pad; tampons) received one point and those who chose only disposable pads were given no points. The preference for sustainable score ranged from 0-2, with higher score indicating greater preference for sustainable materials.

Secondary Outcomes

Secondary Outcomes (end points)
We also included three secondary outcomes: women’s willingness to adapt menstrual practices in terms of use and disposal; a measure of women’s awareness of products beyond traditional cloth and disposable pads; and a measure of women’s beliefs about menstruation and menstrual products, including their beliefs about the need for drying cloth in direct sunlight. These outcomes were chosen because in combination they encompassed women’s attitudes towards menstrual materials and practices that are more sustainable than using disposable pads.
Secondary Outcomes (explanation)
1. Willing to adapt menstrual practices: This measures women’s willingness to adopt sustainable practices in two areas: use and waste management. Responses were noted on three questions:
- “Would you be willing to try a new sustainable menstrual product?”
- “Would you be willing to pay for the safe waste disposal of your menstrual absorbent?”
- “Would you be willing to dig a pit for burial of compostable menstrual product?”
A woman received one point if she answered “yes” to the use question and one point for answering “yes” to either of the disposal questions. Thus, the willingness to adapt score ranges from 0-2, with higher score indicating greater willingness to adapt practices.
2. Aware of alternatives to cloth and pad: This measures women’s awareness of the range of menstrual materials beyond traditional cloth and disposable pad. Women were asked to name or describe all the menstrual material they were aware of. For each menstrual material they named or described other than traditional cloth or disposable pad they were given one point. The knowledge of menstrual products scores ranges from 0 to 4, with higher scores indicating greater knowledge of menstrual materials beyond cloth and pad.
3. Beliefs about periods & products: Beliefs about menstruation and menstrual products is measured using the responses women gave to three questions:
- “Should girls and women continue with their normal activities during their menses?”
- “Does menstrual cloth need direct sunlight drying after wash?”
- “If correctly used, can cloth provide equally good menstrual protection as a disposable pad?”
A woman received one point for each question she answered “yes”. Thus, the possible range of scores are 0-3, with higher score indicating more accurate beliefs about menstrual materials.

Experimental Design

Experimental Design
The study design included repeat cross-sectional surveys over six months to quantify the effects of providing women with complete information about period products compared with combining knowledge provision with reusable cloth pad or disposable pads on women’s preferences for menstrual materials and practices.

In consultation with partner NGOs, ten areas were identified to achieve a mix of geographical spread, access to amenities and other considerations like safety of enumerators, accessibility etc. From each of the study sites, a random sample of 50 households was created. From this list, we removed households that were known to reside in the area only intermittently and households that had no women in the age group 18-45 years of age. Using stratified random sampling, the remaining women were allocated to one of the three study conditions using the ratio of 4 women to product plus information condition for every 1 woman to the information only condition.
Experimental Design Details
Randomization Method
Public lottery in presence of study partners (done in office)
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
10 sites across the city of Hyderabad, Telangana
Sample size: planned number of observations
500
Sample size (or number of clusters) by treatment arms
Stratified random sampling was used in this pilot to allocate women to one of the three study conditions: Disposable (n = 200), Reusable (n = 200) and control Inform-only (n = 100). As the main aim of the study was to quantify the effects of exposure to reusable alternatives to disposable pads, the control inform-only condition was kept smaller than the two arms providing menstrual products. Information on the range of menstrual materials was provided to women across all three conditions.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Sample size calculations assumed a 30% increase in preference for reusable menstrual materials after exposure to these alternatives, requiring a total population of 386 (193 per arm), providing 85% power with 0.05 alpha.
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
October 27, 2017, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
May 25, 2018, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
10 sites across city of Hyderabad
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
The final sample analysed in the three study conditions were 277.
Final Sample Size (or Number of Clusters) by Treatment Arms
Disposable (n = 127); Reusable (n = 125) and Inform-only (n = 25).
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials