A sexual and reproductive health intervention for self-help groups in rural Tamil Nadu

Last registered on February 24, 2025
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Pre-Trial

Trial Information

General Information

Title
A sexual and reproductive health intervention for self-help groups in rural Tamil Nadu
RCT ID
AEARCTR-0014198
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, 1:45 PM EDT

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

Last updated
February 24, 2025, 10:51 PM EST

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

Locations

Country
India
Region
Tamil Nadu

Primary Investigator

Name
David Levine
Affiliation
Haas School of Business
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
Vidya Mahambare
PI Affiliation
Great Lakes Institute of Management, Chennai
Contact Investigator

Additional Trial Information

Status
In development
Start date
2024-09-02
End date
2026-07-31
Keywords
Behavior, Gender, Health
Additional Keywords
Menstrual cup, Menstrual hygiene, free trials, marketing
JEL code(s)
I14, D12, M31, O15
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Women in poor nations often have poor menstrual hygiene. We are testing whether an intervention within rural self-help groups can address these challenges. We focus on behavior change beyond education. We use illustrated stories, brief animations, and role-play to make content vivid. We address perceived social norms, by giving the women in the self-help group an opportunity to collectively endorse safer behaviors. We want women to control their bodies and lives. We provide risk-free trials and free samples of affordable menstrual cups (M-cups) that can improve hygiene, make it easier to go to work outside the home, and save money. The objective is to understand the scope for scaling up the adoption of M-cups among married women in India to promote positive change and advance menstrual health initiatives and the adoption of M-cups as an affordable and convenient option. Compared to the status quo, we remove barriers on the supply side by creating a supply chain for menstrual cups. \
* The module focuses on changing women’s perceptions of the norms of her community, and clarifying the frequently asked questions and answers on the usage of menstrual cups so they accept the new behaviors (e.g., cooking while menstruating) and encourage their peers to also accept the new behaviors. We take advantage of increasing smartphone usage in the rural community by creating a WhatsApp group among women to share videos and presentations on MHM.Distributing engaging illustrated stories and informative videos
External Link(s)

Registration Citation

Citation
Levine, David and Vidya Mahambare. 2025. "A sexual and reproductive health intervention for self-help groups in rural Tamil Nadu." AEA RCT Registry. February 24. https://doi.org/10.1257/rct.14198-1.3
Sponsors & Partners

Partner

Name
Great Lakes Institute of Management, Chennai?
Type
none
URL
https://www.greatlakes.edu.in/admissions/?utm_source=google&utm_medium=search&utm_campaign=HOWL_GL_PGPM_Search_Brand_18-24_Aug24&utm_adgroup=Brand&utm_keyword=great%20lakes%20pgpm%20chennai&gad_source=1&gclid=Cj0KCQjwpP63BhDYARIsAOQkATb8LNIYMxqtdrnqS0jS6NcMvjRAmtd0rmuOzK0jzNPecElYkvAHr5AaAtEVEALw_wcB

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Experimental Details

Interventions

Intervention(s)
We provide a vivid marketing presentation to women in self-help groups in rural Karnataka.

In some groups we provide free trials for 3 months. Women can pay for the cup after 3 months or return them for disposal and owe nothing. We encourage, but do not require, that women share their experience with the cups.

If multiple women in a group volunteer for a free trial, we randomize which women receive one.

Intervention Start Date
2024-11-19
Intervention End Date
2025-07-31

Primary Outcomes

Primary Outcomes (end points)
Purchase of cups in meetings with and without free trials.
Primary Outcomes (explanation)
There will be no direct benefit to the participants, and we do not pay them to participate. However, the indirect benefit is that we hope that the information gained from the study will help improve women's health in India.
Also the menstrual cups will be distributed free for one arm and for free trial for another arm.
There may be meaningful benefits to purchasing a menstrual cup: Better health (if shifting away from cloths); saving money (if shifting away from menstrual pads); fewer leaks; and ease of working or attending school away from home (as cups do not need to be changed for 8-12 hours). If a woman accepts and free trial and does not like her cup, she can return it and get her money back.


Secondary Outcomes

Secondary Outcomes (end points)
Purchase of cups by women with and without free trials (among women interested in a trial).
Spillover effects of trials on other women in the group
Secondary Outcomes (explanation)
There will be no direct benefit to the participants, and we do not pay them to participate. However, the indirect benefit is that we hope that the information gained from the study will help improve women's health in India.
Also the menstrual cups will be distributed free for one arm and for free trial for another arm.
There may be meaningful benefits to purchasing a menstrual cup: Better health (if shifting away from cloths); saving money (if shifting away from menstrual pads); fewer leaks; and ease of working or attending school away from home (as cups do not need to be changed for 8-12 hours). If a woman accepts and free trial and does not like her cup, she can return it and get her money back.

Experimental Design

Experimental Design
We will randomize self-help groups. Baseline interview
We will select random women to interview for the baseline. We may interview 100% of women if funds permit. Interviewers will take oral informed consent and collect a baseline survey. The survey is in Section 17- Attachments.

Intervention
A cluster sampling method will be followed. We will randomize groups into 3 study arms, one arm with a free sample of menstrual cups, another with a free trial of menstrual cups on a voluntary basis, and a third one will be a sales/outright purchase arm.

We will hire and train self-help group facilitators. In the treatment arm, each session will be 60 minutes. (Self-help group meetings can be somewhat longer than our sessions, as the women handle savings and loans, group elections, etc.)
If we randomize and characteristics(Remoteness, income, education, Scheduled Caste /Scheduled Tribe, # of adults living with)
at baseline predict treatment (F test P value < 0.05), we will re-randomize.

Experimental Design Details
Not available
Randomization Method
The PI will randoimze groups.
Volunteers will randomly receive a cup by pulling a lottery number in the meeting.
Randomization Unit
Groups are the unit of randomization for offering a free trial.
Women are the unit ofr andomization for receiving a free trial (among women who volunteered, if more than one volunteered).
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
120 groups
Sample size: planned number of observations
Each study group will consist of two self-help groups, which together will include eligible women for participation in the study. A study group will consist of approximately 15 to 20 women who are qualified to participate in the study. We will aim for 40 women's study groups in each district. If one district has challenges, we may end up with more or less than 40 study groups per district.
Sample size (or number of clusters) by treatment arms
40 groups in each treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
University of California, Berkeley
IRB Approval Date
2023-11-08
IRB Approval Number
2022-11-15805
Analysis Plan