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Field
Primary Outcomes (Explanation)
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Before
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.
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After
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.
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Field
Experimental Design (Public)
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Before
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.)
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After
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.
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