NCT05732142

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
293

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

February 7, 2023

Last Update Submit

June 5, 2025

Conditions

ContraceptionGender Equity

Keywords

Family PlanningInfant VaccinationLinked CareIndia

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months after delivery

Secondary Outcomes (5)

  • Feasibility, acceptability and appropriateness of the PiVOT intervention (quantitative)

    6 months after delivery

  • Proportion of women using modern contraception at 12 months postpartum

    12 months after delivery

  • Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among participants

    6 months postpartum

  • Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among providers of the program

    6 months postpartum

  • Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among husbands of participants

    6 months postpartum

Study Arms (2)

PIVoT

EXPERIMENTAL

Gender-transformative family planning counseling and contraception provision at the time of infant vaccination

Other: Postpartum Integration of Vaccines and Contraception Through Gender-Transformative Programming(PIVoT)

Standard of care

NO INTERVENTION

Standard infant vaccination and family planning referrals

Interventions

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.

PIVoT

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 may not qualify if:

  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Junnar Taluka

Pune, Maharashtra, India

Location

Study Officials

  • Sarah Averbach, MD, MAS

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • Shahina Begum, PhD

    Indian Council of Medical Research-National Institute for Research in Reproductive and Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 16, 2023

Study Start

September 1, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)IN(1)