Experimental Design Details
The subject population will consist of rural women who are members of JVK and between the ages of 18-45. These women are literate and willing to participate in the survey. Almost all participants will be poor or middle-class. The primary languages spoken are Tulu and Kannada, which are also the languages of the intervention.
State the maximum number of subjects planned for the study. This number should account for all subjects to be recruited, including those who may drop out or be found ineligible. Explain how the number of subjects needed to answer the research question was determined.
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.
Personnel Details
Enumerators: Aged 20-30, they are students with higher education levels than the average self-help group member. Their responsibilities include administering the baseline survey and conducting the intervention through sales presentations.
Coordinators: Aged 21-50, these individuals are the Taluk coordinators across seven intervention Taluks. They assist in identifying groups, organizing meetings, and providing support as needed.
Recruitment
Identification and Selection of Participants
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.
Study Participant Selection and Consent
During education meetings, the coordinator will announce that some women have been randomly selected for an interview, emphasizing that participation is entirely voluntary. Following the intervention, group members will again be randomly selected for surveys.
Enumerators will obtain oral informed consent from participants, clarifying that there are no negative consequences for declining participation and that they may withdraw at any time. Coordinators will receive a free menstrual cup as part of the intervention, but they are free to decline the cup. They may receive the cup regardless of whether they participate in the survey or share their experiences with others.
Eligibility Criteria
Women must meet the following criteria to participate:
Member of a JVK group
Aged 18-45
Literate
Willing to participate in the survey
Menstruating and not pregnant
Once eligibility is confirmed, the survey is explained, informed consent is sought, and data is collected from willing participants. Following data collection, a sales presentation is conducted:
Control group: Menstrual cups are offered for purchase.
Treatment group: Interested participants enter a lottery for a free trial cup. Those who do not win but wish to purchase a cup may do so.
Recruitment Materials
No additional recruitment materials are required, as JVK’s existing education groups serve as the primary recruitment mechanism. No advertisements, flyers, or external recruitment efforts will be used. Recruitment for surveys will be conducted through informed oral consent. If a participant prefers a telephone interview, their phone number will be collected with consent.
Compensation and Costs No compensation will be provided for participation. Refreshments will be arranged during meetings. There are no costs to subjects or their insurance providers.
Study Procedures
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.
Marketing of Menstrual Cups
Marketing of menstrual cups is an ongoing JVK activity, so informed consent is not required for participation in marketing meetings. JVK coordinators will be randomized to receive free menstrual cups at different times and will be invited to share their experiences voluntarily.
Some group coordinators will distribute free trial cups to interested members. Participants will be informed that:
The free trial is optional.
If selected, they may try the cup or decline it.
If they try it, they may keep or return it.
Keeping the free trial cup incurs a cost.
Intervention Data Collection
Coordinators will record names, ages, and roles of interested participants on JVK’s standard sales datasheets. These sheets will also track free trial recipients and those purchasing menstrual cups. If no members express interest, this will be recorded, and the group will not receive a free trial.
Menstrual cups will be distributed at subsequent meetings based on availability. JVK will provide de-identified data on free trials and purchases to researchers, excluding personal identifiers such as phone numbers and names. Data will categorize participants based on whether they received and retained a free trial, received and returned a free trial, volunteered for a trial but did not receive one, or did not volunteer at all.
Endline Data Collection
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.