Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India
- Conditions
- Contraceptive BehaviorPregnancy, Unplanned
- Interventions
- Behavioral: TARANG
- Registration Number
- NCT06024616
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TARANG arm TARANG 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).
- Primary Outcome Measures
Name Time Method Rate of unintended pregnancy 6 months and 18-months follow-up 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.
Modern contraceptive use 6 months and 18-months follow-up 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.
- Secondary Outcome Measures
Name Time Method Time to pregnancy 6 months and 18-months follow-up 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.
Measures of reproductive autonomy/empowerment 6 months and 18-months follow-up 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.
Individual attitudes towards intimate partner violence (IPV) 6 months and 18-months follow-up 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.
Desired pregnancy 6 months and 18-months follow-up 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.
Trial Locations
- Locations (1)
Vikalp Sansthan
🇮🇳Udaipur, Rajasthan, India