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Postpartum Integration of Vaccines and Contraception Trial

NCT05732142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2025-06-10

No results posted yet for this study

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.

Conditions

  • Contraception
  • Gender Equity

Interventions

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Sarah Averbach, MD, MAS · University of California, San Diego

  • Shahina Begum, PhD · Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05732142 on ClinicalTrials.gov