ContraceptionPIVoTNCT05732142
Postpartum Integration of Vaccines and Contraception Trial
A study testing Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT) in people with Contraception and Gender Equity, run by University of California, San Diego at 2 sites in 2 countries.
Trial summary
This study aims to examine how to implement a gender-transformative post-partum family planning program integrated into community-based infant vaccination services, and to evaluate preliminary effectiveness of this approach on postpartum contraceptive use in a low resource, rural setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Gender Equity
- What is being tested?
- Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postpartum women who delivered a baby within the past 12 weeks
- Speak Marathi
- Reside in rural Maharashtra
- Did not undergo sterilization, hysterectomy or immediate postpartum intrauterine device (IUD) placement
Who cannot join
- Currently pregnant
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
This study aims to examine how to implement a gender-transformative post-partum family planning program integrated into community-based infant vaccination services, and to evaluate preliminary effectiveness of this approach on postpartum contraceptive use in a low resource, rural setting.
Read the detailed description
Using effective postpartum contraception allows postpartum people to prevent short inter-pregnancy intervals which are associated with an increased risk of maternal and infant morbidity and mortality. India is the country with the highest number of women with an unmet need for contraception, and postpartum and rural women are those with the greatest need. Uptake of postpartum contraception among women in rural India is low; less than half of postpartum women use contraception within the first year after delivery, and many births do not follow the recommended interval.
A promising intervention to address barriers to family planning care is to build on an existing successful health program, the infant vaccination program, by linking family planning services with infant vaccination. India's Ministry of Health has promoted community-based delivery of infant vaccinations, and monthly childhood vaccination services are offered at Village Health and Nutrition Days typically held at Anganwadi Community Centers. Six-week vaccination rates are high, indicating that these services are routinely used by families of young infants, which provides an opportunity to reach postpartum women simultaneously. This programming addresses gender-inequitable social norms and has shown to facilitate more successful family planning intervention but has not been studied among postpartum women. This study will adapt a gender-transformative family planning intervention to support community-based delivery of family planning with infant vaccination; this intervention has the potential to increase family planning use among postpartum women with unmet need in low-resources and rural settings.
This is a two-arm, cluster randomized-trial where postpartum women will be assigned to participation in the linked care model (PIVoT) or the standard of care (referring women to public health centers for family planning counseling and contraceptive provision). The study team will enroll 286 women in the study, 143 in each the intervention and control arms. Randomization will occur at the subcenter level. Participants will be recruited among postpartum women presenting for infant vaccination services at VHND.
Follow-up will occur with women at 6 months and 12 months postpartum and outcomes will be assessed via tablet-based surveys.
- Conditions
- Contraception, Gender Equity
- Being tested
- Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT)
- Keywords
- Family Planning, Infant Vaccination, Linked Care, India
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT)Other
The PIVoT intervention is a 30-minute focused information exchange that supports shared contraceptive decision making. The program includes a gender-equity and family planning curriculum covering basic family planning information as well as gender norms and son preference and interactive family planning method index cards (detailing method characteristics, use, duration of action, efficacy, side effects, and contraindications for each method). The program is designed to support person-centered contraceptive choice and encourages women to consider joint family planning decision-making with male partners. If a contraceptive method is desired, it will be provided by nurses who are trained to provide comprehensive family planning care.
| Study group | Role | What they receive |
|---|---|---|
| PIVoT | Experimental | Gender-transformative family planning counseling and contraception provision at the time of infant vaccination Receives: Other: Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT) |
| Standard of care | No intervention | Standard infant vaccination and family planning referrals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Women Using Modern Contraception at 6 Months Postpartum
Contraceptive use will be measured through a self-reported survey collected at 6 months postpartum.
Measured: 6 months after delivery
Secondary outcomes (2)
Feasibility, Acceptability and Appropriateness of the PiVOT Intervention
Self-reported survey questions using validated items regarding feasibility, acceptability and appropriateness of linked care will be collected at 6 months postpartum. Participants will rate the 3 constructs using 12 items comprising 3 4-item scales with a 5-point Likert scale: completely agree=1, agree=2, neither agree nor disagree=3, disagree=4, completely disagree=5. Higher scores on these items reflect more supportive attitudes toward the linked care model.
Measured: 6 months after delivery
Proportion of Women Using Modern Contraception at 12 Months Postpartum
Contraceptive use will be measured through a self-reported survey collected at 12 months postpartum
Measured: 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Sep 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Sarah Averbach, MD MAS, University of California, San Diego
- Investigators
- Sarah Averbach, MD, MAS, Principal investigator, University of California, San DiegoShahina Begum, PhD, Principal investigator, Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732142
- Sponsor's protocol ID
- 804819
- Acronym
- PIVoT
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2023
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Integration of Vaccines and Contraception Trial
- ClinicalTrials.gov ID
- NCT05732142
- Acronym / sponsor ID
- PIVoT / 804819
- Conditions
- Contraception, Gender Equity
- Keywords
- Family Planning, Infant Vaccination, Linked Care, India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine how to implement a gender-transformative post-partum family planning program integrated into community-based infant vaccination services, and to evaluate preliminary effectiveness of this approach on postpartum contraceptive use in a low resource, rural setting.
Detailed description
Using effective postpartum contraception allows postpartum people to prevent short inter-pregnancy intervals which are associated with an increased risk of maternal and infant morbidity and mortality. India is the country with the highest number of women with an unmet need for contraception, and postpartum and rural women are those with the greatest need. Uptake of postpartum contraception among women in rural India is low; less than half of postpartum women use contraception within the first year after delivery, and many births do not follow the recommended interval.
A promising intervention to address barriers to family planning care is to build on an existing successful health program, the infant vaccination program, by linking family planning services with infant vaccination. India's Ministry of Health has promoted community-based delivery of infant vaccinations, and monthly childhood vaccination services are offered at Village Health and Nutrition Days typically held at Anganwadi Community Centers. Six-week vaccination rates are high, indicating that these services are routinely used by families of young infants, which provides an opportunity to reach postpartum women simultaneously. This programming addresses gender-inequitable social norms and has shown to facilitate more successful family planning intervention but has not been studied among postpartum women. This study will adapt a gender-transformative family planning intervention to support community-based delivery of family planning with infant vaccination; this intervention has the potential to increase family planning use among postpartum women with unmet need in low-resources and rural settings.
This is a two-arm, cluster randomized-trial where postpartum women will be assigned to participation in the linked care model (PIVoT) or the standard of care (referring women to public health centers for family planning counseling and contraceptive provision). The study team will enroll 286 women in the study, 143 in each the intervention and control arms. Randomization will occur at the subcenter level. Participants will be recruited among postpartum women presenting for infant vaccination services at VHND.
Follow-up will occur with women at 6 months and 12 months postpartum and outcomes will be assessed via tablet-based surveys.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIVoT | Experimental | Other: Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT)Gender-transformative family planning counseling and contraception provision at the time of infant vaccination |
| Standard of care | No intervention | –Standard infant vaccination and family planning referrals |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postpartum women who delivered a baby within the past 12 weeks
- Speak Marathi
- Reside in rural Maharashtra
- Did not undergo sterilization, hysterectomy or immediate postpartum intrauterine device (IUD) placement
Key exclusion criteria (1 listed)
- Currently pregnant
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 |
|---|---|---|
| Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT)The PIVoT intervention is a 30-minute focused information exchange that supports shared contraceptive decision making. The program includes a gender-equity and family planning curriculum covering basic family planning information as well as gender norms and son preference and interactive family planning method index cards (detailing method characteristics, use, duration of action, efficacy, side effects, and contraindications for each method). The program is designed to support person-centered contraceptive choice and encourages women to consider joint family planning decision-making with male partners. If a contraceptive method is desired, it will be provided by nurses who are trained to provide comprehensive family planning care. | Other | PIVoT |
Primary outcome
Proportion of Women Using Modern Contraception at 6 Months Postpartum
Time frame: 6 months after delivery
Contraceptive use will be measured through a self-reported survey collected at 6 months postpartum.
2 secondary outcomes
Feasibility, Acceptability and Appropriateness of the PiVOT Intervention
Time frame: 6 months after delivery
Proportion of Women Using Modern Contraception at 12 Months Postpartum
Time frame: 12 months after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarah Averbach, MD, MAS principal investigator
University of California, San Diego
Shahina Begum, PhD principal investigator
Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT) in people with Contraception and Gender Equity, run by University of California, San Diego at 2 sites in 2 countries.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Women Using Modern Contraception at 6 Months Postpartum (time frame: 6 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.