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

NCT06024616 | Recruiting

• 1 other identifier: R01HD108252
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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. 1.Navigating newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills)
2. 2.Improving women's awareness of sexual reproductive health
3. 3.Challenging inequitable gender norms with an aim to reduce unintended pregnancies.
4. 4.Life skills education to enable them to have improved social mobility, decision-making, and agency.

Conditions

Pregnancy, Unplanned; Contraceptive Behavior

Outcome Measures

Primary Outcomes (2)

• Rate of unintended pregnancy

  Data for analysis consist of time 'at risk' - active in the study and not known to be pregnant already - and the binary outcome of 'unintended' pregnancy. The binary outcome of pregnancy will be as per self-reported answers during Demographic Health Survey style monthly calendar on whether pregnant at any time during the month, and whether the pregnancy was planned / wanted. Since eligibility is based on participants stating that they wanted to wait at least a year to get pregnant, that it was "up to god" or they didn't know, the primary outcome will assume that all pregnancies were unintended. Additional sensitivity analyses will be done with a second definition of "unintended pregnancy" to accommodate intention to change over time, so only pregnancies where respondents said they wanted to delay in the prior round will be counted as unintended.

  6 months and 18-months follow-up

• Modern contraceptive use

  This will be calculated at the endline (18-months post survey) based on women's self-reported data through a detailed set of questions modeled on the Demographic Health Survey's contraceptive calendar question. For each month of the study/follow-up period, women will be asked whether they used any contraceptive method, and if yes, which type(s). A binary indicator of modern contraceptive use by month will be constructed. Modern contraceptive methods will include copper-T (intrauterine device), (Antara) injectable, emergency contraception, oral contraceptive pill, male and female condoms, male and female sterilization, lactational amenorrhea method, foam/jelly, diaphragm and standard-days method), as defined by the Demographic Health Survey in India. Person months during pregnancy and immediate postpartum will be censored for this analysis.

  6 months and 18-months follow-up

Secondary Outcomes (4)

• Desired pregnancy

  6 months and 18-months follow-up

• Individual attitudes towards intimate partner violence (IPV)

  6 months and 18-months follow-up

• Measures of reproductive autonomy/empowerment

  6 months and 18-months follow-up

• Time to pregnancy

  6 months and 18-months follow-up

Study Arms (2)

TARANG arm

EXPERIMENTAL

Participants will participate in TARANG and receive the following a total of 14 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 to reduce unintended pregnancies. 4. Life skills education to enable them to have improved social mobility, decision-making, and agency. The TARANG intervention will be delivered by Vikalp (a registered non-governmental organization implementing the intervention).

Behavioral: TARANG

Control arm

NO INTERVENTION

Participants in the control arm receive standard of care--contraceptive access through community health workers and routine counseling by community health workers

Interventions

TARANG BEHAVIORAL

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.

TARANG arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• years or more at the time of the wedding
• Mother and wife are eligible for the study participation
• 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

You may not qualify if:

• Wanting to have a child in the next 12 months at the time of baseline
• Cognitive ability to participate in surveys

Sponsors & Collaborators

• University of California, San Francisco: lead
• Network for Engineering and Economics Research and Management: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Vikalp Sansthan: collaborator

Study Sites (1)

Vikalp Sansthan

Udaipur, Rajasthan, 313011, India

RECRUITING

Related Publications (1)

• Diamond-Smith N, Gopalakrishnan L, Leslie H, Katz E, Harper C, Weiser S, Patil SR. Life skills and reproductive health empowerment intervention for newly married women and their families to reduce unintended pregnancy in India: protocol for the TARANG cluster randomised controlled trial. BMJ Open. 2024 Apr 30;14(4):e086778. doi: 10.1136/bmjopen-2024-086778.

  PMID: 38688674 DERIVED

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Nadia Diamond-Smith, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Diamond-Smith, PhD

CONTACT

510 914-4586; nadia.diamond-smith@ucsf.edu

Sumeet R Patil, PhD

CONTACT

9540844900; srpatil@neerman.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 6, 2023
• Study Start: April 15, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: At the end of 2027 when the main study ends, investigators will share a de-identified dataset to be hosted on OpenICPSR, a portal approved by NIH for sharing data. It will be available indefinitely.

Locations

IN (1)