Postpartum Integration of Vaccines and Contraception Trial — PIVoT  

Contraception Clinical Trial

Official title: Postpartum Integration of Vaccines and Contraception Trial

Status Recruiting

Clinical 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.

Clinical Trial 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. 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. ;

Related Conditions & MeSH terms

• Contraception

• NCT number: NCT05732142
• Study type: Interventional
• Source: University of California, San Diego
• Contact: Gennifer Kully, MSc
• Phone: 858-329-4464
• Email: gkully@health.ucsd.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Completion date: February 1, 2025