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

Contraceptive Behavior Clinical Trial

— TARANG  

Official title:

The Impact of Group-based Life Skills and Health Empowerment for Young, Married, Women to Avoid Unintended Pregnancies in India

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024616
• Other study ID #: R01HD108252
• Secondary ID: R01HD108252
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: September 2027

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Nadia Diamond-Smith, PhD
• Phone: 510 914-4586
• Email: nadia.diamond-smith[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Behavior
• Pregnancy, Unplanned

Intervention

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.

Locations

Country	Name	City	State
India	Vikalp Sansthan	Udaipur	Rajasthan

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Network for Engineering and Economics Research and Management, Vikalp Sansthan

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Desired pregnancy	Continuous outcome. Stated pregnancy intention using an adapted Desire to Avoid Pregnancy (DAP) Scale. Self-assessed preferences for having a baby will be measured using the DAP Scale. The DAP scale is a 14-item measure of a person's preferences about a future pregnancy and childbearing. Each item is scored from 0-4, with higher scores indicating a greater preference to avoid pregnancy but investigators will use the 9-items on childbirth given the needs of the target population.	6 months and 18-months follow-up
Secondary	Individual attitudes towards intimate partner violence (IPV)	7-item scale that measures attitudes towards intimate partner violence against women. To construct the index, items are summed to create a score ranging from 0-7. This has been validated in India (in the Demographic Health Surveys). To be used as a continuous outcome.	6 months and 18-months follow-up
Secondary	Measures of reproductive autonomy/empowerment	The Women's and Girls' Sexual and Reproductive Health (SRH) Empowerment Index was adapted to have 26 relevant items for existence of choice (autonomy) sub-scales and exercise of choice (self-efficacy (SE), decision-making (DM), negotiation (NG)) subscales. To construct the index, summary scores for each domain and outcome by averaging scores for relevant items are computed. Three outcome-specific empowerment scores (sexual empowerment, contraceptive empowerment and pregnancy empowerment) can be computed by adding the relevant summary scores for the existence of choice and exercise of choice domains. Finally, to examine the contribution of empowerment across the three SRH dimensions, a multidimensional SRH additive index comprising all items included in the three empowerment subscales can be computed. To be used as continuous outcome.	6 months and 18-months follow-up
Secondary	Time to pregnancy	Continuous outcome. This will be calculated as time elapsed in months between the date of study enrollment and date of last missed period constructed on basis of documentary records or recall. This will be constructed for intended/unintended, terminated/aborted, and full term pregnancies as reported by the woman.	6 months and 18-months follow-up