An interventional study of TARANG in Pregnancy, Unplanned and Contraceptive Behavior, sponsored by University of California, San Francisco. Active, not recruiting at 1 site in India. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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:
Investigators will compare the TARANG intervention with the standard of care to see if it delays unintended pregnancies among women.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Inclusion Criteria for newly married women:
Women not planning to migrate out of the area for the period of the intervention
Inclusion criteria for husband:
Inclusion criteria for mother-in-law:
Exclusion criteria for newly married women:
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).
Behavioral: TARANG
Participants in the control arm receive standard of care--contraceptive access through community health workers and routine counseling by community health workers
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.
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.
Time frame: 6 months and 18-months follow-up
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.
Time frame: 6 months and 18-months follow-up
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.
Time frame: 6 months and 18-months follow-up
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.
Time frame: 6 months and 18-months follow-up
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.
Time frame: 6 months and 18-months follow-up
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.
Time frame: 6 months and 18-months follow-up
Plan to share: Yes — At the end of the project and completion of the planned statistical analyses, UCSF and NEERMAN will create a de-identified dataset to be hosted on a public data-sharing platform per the guidance of the latest NIH data sharing. Until then, in accordance with this data-sharing agreement, co-investigators on the research team will not share the dataset with outsiders unless these individuals have signed a data-sharing agreement and this agreement is approved by the Principal and site co-investigators on the research team.
Supporting information: Study protocol
Time frame: At the end of 2027 when the main study ends, investigators will share a de-identified dataset to be hosted on OpenICPSR, a portal approved by NIH for sharing data. It will be available indefinitely.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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