R21HD108351

Increasing access to postpartum contraception by linking family planning and infant vaccination services - Project summary/abstract:

Family planning (FP), including provision of contraception, is care that supports individuals to achieve their desired number, timing, and spacing of children. Expanding access to postpartum FP can prevent maternal and infant morbidity and mortality by decreasing unintended pregnancy and short inter-pregnancy intervals.

India is the country with the largest number of women with an unmet need for contraception, and rural postpartum women are among those with the highest unmet need. Community-based infant vaccination programs in rural India are an ideal setting to provide postpartum FP care because they are well-attended, and the infant vaccine schedule provides multiple opportunities to offer FP care including outreach and follow-up to postpartum women and couples.

Our prior work in the region shows that gender-transformative programs – i.e., those that address restrictive gender norms (social expectations of people’s behavior based on their perceived gender) – are associated with increased contraceptive use and agency in contraceptive decision-making.

Our central hypothesis is that linking community-based, gender-transformative FP care with existing public infant vaccination programs will reach more rural postpartum women and couples and improve uptake of postpartum contraception.

The objective of this study is to pilot test PIVOT (Postpartum Integration of Vaccines and Contraception through Gender-Transformative Programming), delivered by a nurse as a 30-minute counseling session plus contraception provision if desired (including intrauterine devices) at three infant vaccine visits that occur over an 8-week period in rural India.

Our qualitative research from the region demonstrate that this model of care is feasible and acceptable to both our target population and providers.

Using a hybrid-effectiveness design, the Proctor implementation outcomes framework, and a mixed-methods approach, including a two-arm cluster randomized controlled trial, this study aims to assess the effect of the PIVOT intervention on:

1. Implementation outcomes -- intervention feasibility, acceptability, appropriateness, uptake, and fidelity
2. Preliminary effectiveness -- contraceptive use, quality of care, and contraceptive decision-making agency.

Villages (N=12) in rural India will be randomized to deliver the PIVOT intervention or the standard of care (referral to public health centers for FP counseling and provision of contraception) to postpartum women at infant vaccination visits.

Implementation outcomes will be assessed via surveys from PIVOT participants (N=294), in-depth interviews with a subset of women participants, their husbands, and PIVOT providers (N=40), and PIVOT session observations.

Our preliminary effectiveness evaluation will involve baseline and 6-month follow-up surveys with trial participants assessing contraceptive use and agency in contraceptive decision-making and their perceptions of quality of care.

This study has the potential to guide implementation of an innovative gender-transformative FP intervention which increases access to contraception for postpartum women with unmet need.

San Diego University Of California

NOT APPLICABLE

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

La Jolla, California 92093 United States

Single Zip Code

NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) (PA-20-194)

Amendment Since initial award the total obligations have increased 78% from $225,365 to $400,230.