NCT06024616 Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India
| NCT ID | NCT06024616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Pregnancy, Unplanned |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,400 participants in total. It began in 2024-04-15 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 the prevalence of contraceptive use and time-to-pregnancy (primary outcomes) in Rajasthan, India. Participants will participate in TARANG intervention and receive the following sessions: 1. Navigating newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills) 2. Improving women's awareness of sexual reproductive health 3. Challenging inequitable gender norms with an aim to reduce unintended pregnancies. 4. Life skills education to enable them to have improved social mobility, decision-making, and agency. Investigators will compare the TARANG intervention with the standard of care to see if it delays unintended pregnancies among women.
Eligibility Criteria
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
Contact & Investigator
Nadia Diamond-Smith, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06024616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pregnancy, Unplanned. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06024616 currently recruiting?
Yes, NCT06024616 is actively recruiting participants. Contact the research team at nadia.diamond-smith@ucsf.edu for enrollment information.
Where is the NCT06024616 trial being conducted?
This trial is being conducted at Udaipur, India.
Who is sponsoring the NCT06024616 clinical trial?
NCT06024616 is sponsored by University of California, San Francisco. The principal investigator is Nadia Diamond-Smith, PhD at University of California, San Francisco. The trial plans to enroll 2,400 participants.