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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Contraceptive Behavior; Pregnancy, Unplanned

Treatments: Behavioral: TARANG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06024616

R01HD108252 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,400 participants in 2 patient groups

TARANG arm

Experimental group

Description:

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).

Treatment:

Behavioral: TARANG

Control arm

No Intervention group

Description:

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