Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Sarah Averbach, MD, MAS
Headshot of Sarah Averbach
Sarah Averbach

Description

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.

Details

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. In addition, a total of 40 in-depth interviews will take place with a group of PIVoT intervention participants, their husbands, and health care providers who delivered the program after completion of the study for further evaluation.

Keywords

Contraception, Gender Equity, Family Planning, Infant Vaccination, Linked Care, India, Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT), PIVoT

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

- Currently pregnant

Locations

  • University of California, San Diego in progress, not accepting new patients
    La Jolla California 92093 United States
  • Junnar Taluka accepting new patients
    Pune Maharashtra India

Lead Scientist at UCSD

  • Sarah Averbach, MD, MAS
    Associate Adjunct Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 65 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05732142
Study Type
Interventional
Participants
Expecting 286 study participants
Last Updated