Clinical trial NCT06024616: Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India
Official title: The Impact of Group-based Life Skills and Health Empowerment for Young, Married, Women to Avoid Unintended Pregnancies in India
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy, Unplanned
Contraceptive Behavior
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Network for Engineering and Economics Research and Management
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Vikalp Sansthan
First posted: 2023-09-06
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.


Eligibility 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

Primary outcomes:
measure: Rate of unintended pregnancy
timeFrame: 6 months and 18-months follow-up
measure: Modern contraceptive use
timeFrame: 6 months and 18-months follow-up
Secondary outcomes:
measure: Desired pregnancy
timeFrame: 6 months and 18-months follow-up
measure: Individual attitudes towards intimate partner violence (IPV)
timeFrame: 6 months and 18-months follow-up
measure: Measures of reproductive autonomy/empowerment
timeFrame: 6 months and 18-months follow-up
measure: Time to pregnancy
timeFrame: 6 months and 18-months follow-up
Other outcomes:
Locations:
city: Udaipur
country: India
facility: Vikalp Sansthan
state: Rajasthan
Study officials:
affiliation: University of California, San Francisco
name: Nadia Diamond-Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: