Pregnancy, UnplannedTARANGNCT06024616
Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India
A study testing TARANG in people with Pregnancy, Unplanned and Contraceptive Behavior, run by University of California, San Francisco at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Unplanned, Contraceptive Behavior
- What is being tested?
- TARANG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteIndia
- Study dates
- 15 Apr 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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.)
- 18 years or more at the time of the wedding
- Mother and wife are eligible for the study participation
- 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
Who cannot join
- Wanting to have a child in the next 12 months at the time of baseline
- Cognitive ability to participate in surveys
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Group-based Life Skills and Health Empowerment for Young, Married, Women to Avoid Unintended Pregnancies in India
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:
Read more
- Navigating newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills)
- Improving women's awareness of sexual reproductive health
- Challenging inequitable gender norms with an aim to reduce unintended pregnancies.
- 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.
- Conditions
- Pregnancy, Unplanned, Contraceptive Behavior
- Being tested
- TARANG
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARANGBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TARANG arm | Experimental | 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). Receives: Behavioral: TARANG |
| Control arm | No intervention | Participants in the control arm receive standard of care--contraceptive access through community health workers and routine counseling by community health workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months and 18-months follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months and 18-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start15 Apr 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, UnplannedStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Network for Engineering and Economics Research and Management, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Vikalp Sansthan
- Responsible party
- Sponsor
- Investigators
- Nadia Diamond-Smith, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024616
- Sponsor's protocol ID
- R01HD108252
- Other IDs
- R01HD108252
- Acronym
- TARANG
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Diamond-Smith N, Gopalakrishnan L, Leslie H, Katz E, Harper C, Weiser S, Patil SR. Life skills and reproductive health empowerment intervention for newly married women and their families to reduce unintended pregnancy in India: protocol for the TARANG cluster randomised controlled trial. BMJ Open. 2024 Apr 30;14(4):e086778. doi: 10.1136/bmjopen-2024-086778.
PubMed 38688674
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Group-based Life Skills and Health Empowerment for Young, Married, Women to Avoid Unintended Pregnancies in India
- ClinicalTrials.gov ID
- NCT06024616
- Acronym / sponsor ID
- TARANG / R01HD108252
- Conditions
- Pregnancy, Unplanned, Contraceptive Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Network for Engineering and Economics Research and Management, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Vikalp Sansthan
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Navigating newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills)
- Improving women's awareness of sexual reproductive health
- Challenging inequitable gender norms with an aim to reduce unintended pregnancies.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TARANG arm | Experimental | Behavioral: TARANGParticipants 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). |
| Control arm | No intervention | –Participants in the control arm receive standard of care--contraceptive access through community health workers and routine counseling by community health workers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- Wanting to have a child in the next 12 months at the time of baseline
- Cognitive ability to participate in surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TARANGTARANG 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. | Behavioural | TARANG arm |
Primary outcome
Rate of unintended pregnancy
Time frame: 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
Time frame: 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.
4 secondary outcomes
Desired pregnancy
Time frame: 6 months and 18-months follow-up
Individual attitudes towards intimate partner violence (IPV)
Time frame: 6 months and 18-months follow-up
Measures of reproductive autonomy/empowerment
Time frame: 6 months and 18-months follow-up
Time to pregnancy
Time frame: 6 months and 18-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 38688674Diamond-Smith N, Gopalakrishnan L, Leslie H, Katz E, Harper C, Weiser S, Patil SR. Life skills and reproductive health empowerment intervention for newly married women and their families to reduce unintended pregnancy in India: protocol for the TARANG cluster randomised controlled trial. BMJ Open. 2024 Apr 30;14(4):e086778. doi: 10.1136/bmjopen-2024-086778.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Diamond-Smith, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TARANG in people with Pregnancy, Unplanned and Contraceptive Behavior, run by University of California, San Francisco at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of unintended pregnancy (time frame: 6 months and 18-months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.