Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India

NCT06024616 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

  • Pregnancy, Unplanned
  • Contraceptive Behavior

Interventions

BEHAVIORAL

TARANG

TARANG is aimed to empower young women to navigate newly formed relationships, improve women's awareness of sexual reproductive health, and challenge inequitable gender norms, with an aim to reduce unintended pregnancies and increase use of family planning. The TARANG intervention for newly married women will include 14 group sessions delivered by trained moderators from Vikalp. It will cover three overarching themes, including norms, empowerment, and sexual and reproductive health and wellbeing. Four light-touch sessions for mothers-in-law and one in-person session for husbands of newly married women will be conducted. For husbands, TARANG will include one 2-hour group session within the first month of the intervention, followed by regular and moderated content delivery via videos and take-home exercises over WhatsApp groups. Vikalp will conduct door-to-door listing, and a research team from NEERMAN will recruit households into the study depending on the eligibility criteria.

Sponsors & Collaborators

  • Network for Engineering and Economics Research and Management

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Vikalp Sansthan

    collaborator UNKNOWN
  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Nadia Diamond-Smith, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024616 on ClinicalTrials.gov