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

University of California, San Francisco2,400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

2,400

Conditions

Pregnancy, Unplanned Contraceptive Behavior

Interventions

TARANGBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.