Status:
RECRUITING
Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Network for Engineering and Economics Research and Management
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy, Unplanned
Contraceptive Behavior
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of the cluster randomized trial is to evaluate the impact of a reproductive health and empowerment intervention (TARANG) compared to the standard of care health information (control group) on...
Eligibility Criteria
Inclusion
- Inclusion Criteria for newly married women:
- Age 18-25 years at the time of the wedding
- Married women have permanently moved in their husbands home in the most recent wedding season (recruitment month going backwards up to October of the previous year)
- Not wanting to get pregnant within 1 year at recruitment/enrollment
- Have not had a live birth previously and not currently pregnant
- Women not planning to migrate out of the area for the period of the intervention
- • Has a living husband who is willing to consent and participate in the study in person or remotely (over phone)
- Has a living, co-residing mother-in-law type person\* (see definition below) who is willing to consent and participate in the study in person (A mother-in-law type of person should be staying in the same household for the period of the intervention and has consented to participate in the study. Mother-in-law is defined as any senior woman (from a previous generation of the DIL) who are responsible for their daughter-in-law and cohabiting in the same household as their daughter-in-law (Note - household would mean a family unit which shares the same kitchen). This will usually be the biological mother of the husband, but it can be stepmother, grandmother, aunt, etc.)
- Inclusion criteria for husband:
- 18 years or more at the time of the wedding
- Mother and wife are eligible for the study participation
- Inclusion criteria for mother-in-law:
- Consent to participate in the study
- Assents for daughter-in-law to participate in the study
- Son and the daughter-in-law are eligible for study participation
- Exclusion criteria for newly married women:
- Wanting to have a child in the next 12 months at the time of baseline
- Cognitive ability to participate in surveys
Exclusion
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT06024616
Start Date
April 15 2024
End Date
September 1 2027
Last Update
July 30 2025
Active Locations (1)
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1
Vikalp Sansthan
Udaipur, Rajasthan, India, 313011