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Last Published February 17, 2025 01:07 PM February 17, 2025 01:17 PM
Intervention (Public) We will market menstrual cups to JVK women's group meetings in rural Karnataka. The meetings are conducted every Sunday for the women where they conduct the baseline survey and also do the intervention presentation. The trial works on the basis of the different taluks Selected: On the basis of instructions provided by JVK state Project officer Ms.Sangeetha. Taluks selected are Kadaba, Bantwala , Moodabidri, Mangalore, Belthangady, Puttur, Belthngady, Guruvayankere. 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.
Primary Outcomes (End Points) Uptake of the menstrual cup among groups with and without the free trial. 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.
Experimental Design (Public) Randomising the JVK Groups on the basis of simple random sampling as Treatment Groups and Control Groups with Equal preferences 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.
Randomization Method The PI will randomize women's meetings. Within a meeting, women interested in a free trial pull numbers from a hat to see who gets a free trial. 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 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
Planned Number of Clusters 100 25 JVK Centers
Planned Number of Observations 4000 women 5000 women
Intervention (Hidden) Each taluk consists of 25 JVK Centres. In Each Taluk 13 Groups have been selected on the basis of Quota Sampling analysing and studying the factors like Group consist More Number of young aged women's, Newly consisted groups, Groups easily accessible to travel and overall observations and considering opinion from JVK Taluk coordinators. Here we also randomising the JVK Groups on the basis of simple Random Sampling as Treatment Groups and Control Groups with Equal preferences Eligibility Criteria: Women must be the member of JVK group Women belongs to Age Group 18-45 Literate Like to participate in Survey Menstruating Women 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. 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. 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.
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