A menstrual health intervention for self-help groups in rural Karnataka

Last registered on February 17, 2025

View Trial History

Pre-Trial

Trial Information

General Information

Title

A menstrual health intervention for self-help groups in rural Karnataka

RCT ID

AEARCTR-0014197

Initial registration date

August 16, 2024

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

August 28, 2024, 1:44 PM EDT

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

Last updated

February 17, 2025, 1:21 PM EST

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

Locations

Country

India

Region

Karnataka

Primary Investigator

Name

David Levine

Affiliation

Haas School of Business

Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status

In development

Start date

2024-08-19

End date

2026-03-31

Keywords

Behavior, Education, Gender, Health, Lab

Additional Keywords

Menstrual cup, menstrual hygiene

JEL code(s)

I14, D12, M31, O15

Secondary IDs

Prior work

This trial does not extend or rely on any prior RCTs.

Abstract

Many older women in Karnataka use rags or cloths when menstruating. Women of all ages often restrict activities, both due to a sense of contamination and the difficulty of changing menstrual supplies when away from home.
We are working with a large Project Jnana Vikasa (JVK), under the SKDRDP Organisation. JVK operates self-help groups with 300,000 members in rural Karnataka and runs educational programs for women in these communities. Since 2022, in select areas, JVK’s educational programs have introduced discussions on menstrual cups. JVK has also marketed and sold the cups wholesale. As part of these efforts, JVK collects data on orders (name, phone number, date) and payments. This data collection is part of JVK’s normal operations and is not human subjects data collected for research purposes.

Women in poor nations often have poor menstrual hygiene. We are testing whether an intervention within rural self-help groups can address these challenges. Specifically, we study:
The relationship between the accessibility of free trials and the increase in the uptake of menstrual cups.
The effect of free trials by peers (which we hypothesize will increase uptake) on the cup adoption rate among peers who did not receive a free trial.

External Link(s)

Registration Citation

Citation

Levine, David. 2025. "A menstrual health intervention for self-help groups in rural Karnataka ." AEA RCT Registry. February 17. https://doi.org/10.1257/rct.14197-2.4

Sponsors & Partners

Experimental Details

Interventions

Intervention(s)

JVK runs monthly education groups and has an established eligibility procedure for selecting participants. The selection process follows the guidelines set by JVK’s State Project Officer, Ms. Sangeetha, and focuses on specific Taluks within the selected districts. The Taluks selected for this study include Kadaba, Bantwala, Moodabidri, Mangalore, Belthangady, Puttur, and Guruvayankere.
Each Taluk consists of 25 JVK Centers, from which 13 -15 groups are selected based on quota sampling. The selection criteria include groups with a higher proportion of young women, newly constituted groups, groups that are easily accessible for travel, and recommendations from JVK Taluk coordinators. The selected JVK groups are then randomly assigned as treatment or control groups using simple random sampling to ensure balanced representation.

Intervention Start Date

2024-08-19

Intervention End Date

2025-03-31

Primary Outcomes

Primary Outcomes (end points)

Uptake of the menstrual cup among groups with and without the free trial.
We have sufficient statistical power to detect changes in our key outcomes with 100 JVK groups comprising 3,000 members.
If any proposed subjects are children/minors, prisoners, pregnant women, those with physical or cognitive impairments, or others who are considered vulnerable to coercion or undue influence, state the rationale for their involvement.
We are working with women’s self-help groups, which largely consist of poor rural and Middle classwomen. Thus, most respondents will belong to this demographic.

Primary Outcomes (explanation)

We specifcially study the relationship between the accessibility of free trials and the increase in the uptake of menstrual cups.
The effect of free trials by peers (which we hypothesize will increase uptake) on the cup adoption rate among peers who did not receive a free trial.

Secondary Outcomes

Secondary Outcomes (end points)

Volunteering for a free trial, purchase rates among those interested in a free trial who did and who did not receive one.

Secondary Outcomes (explanation)

Experimental Design

Survey Details:
The survey covers demographic profile, household profile, menstrual hygiene practices, menstrual problems, attitudes, and knowledge
The survey takes place during a meeting at the center.
Privacy measures: Participants are asked to move to a place where nobody can overhear.
Participants write and mark answers themselves, and we explain/re-read questions if clarification is needed.
The survey is conducted using the FGD method.

Baseline Data Collection
Enumerators will be hired and trained, including instruction on IRB guidelines adapted from CPHS’s materials. After selecting the JVK groups, baseline data collection will proceed as follows:
At educational meetings, the group leader will announce random selection of some women for voluntary participation in a survey.
Surveys will be conducted in a private location or at a later scheduled time at the participant’s preference.
Enumerators will explain the survey’s content, covering menstrual practices, product usage, and attitudes towards menstruation.
Verbal informed consent will be obtained, and the survey will be conducted in Kannada.
Data will be collected using smartphones.

Approximately six months after the intervention, an endline survey identical to the baseline will be conducted. Professor Dhaneshwari will merge sales data with survey responses to analyze purchase behavior among different participant groups. Additionally, data will be collected on returned free trial cups for disposal tracking.

Experimental Design Details

Not available

Randomization Method

There is no deception. Some groups will receive the free sample earlier than others. This staggered roll-out is standard practice in marketing campaigns and NGO programs. JVK frequently implements educational programs that reach some meetings before others. For example, JVK marketed menstrual cups in two regions in 2022 before expanding elsewhere. Therefore, there is no need to disclose the randomized timing of free trials. Once results are available, JVK will receive a report and presentation outline to debrief all subjects about the research.

Randomization Unit

JVK women's meetings are the main randomization
Within a meeting, women interested in a free trial are the unit of randomization, It is clustered by meeting

Was the treatment clustered?

Yes