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Postpartum Vaccines and Contraception Integration for Birth Control (PIVoT Trial)

N/A
Recruiting
Led By Sarah Averbach, MD, MAS
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after delivery
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how to offer family planning services with infant vaccinations in rural, low-resource areas, to see if it encourages post-partum contraceptive use.

Who is the study for?
This trial is for postpartum women who speak Marathi, delivered a baby within the last 8 weeks, live in rural Maharashtra, and have not had sterilization or certain immediate post-birth contraceptive procedures. Pregnant women cannot participate.
What is being tested?
The study tests a program that combines family planning with infant vaccination services to see if it increases birth control use after childbirth in rural areas. It's focused on changing gender norms to improve health outcomes.
What are the potential side effects?
Since this trial involves educational and service integration programs rather than medications, there are no direct medical side effects; however, participants may experience changes in their social or cultural dynamics due to the gender-transformative approach.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of women using modern contraception at 6 months postpartum
Secondary study objectives
Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among husbands of participants
Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among participants
Feasibility, acceptability and appropriateness of the PiVOT intervention (qualitative) among providers of the program
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PIVoTExperimental Treatment1 Intervention
Gender-transformative family planning counseling and contraception provision at the time of infant vaccination
Group II: Standard of careActive Control1 Intervention
Standard infant vaccination and family planning referrals

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,761 Total Patients Enrolled
Indian Council of Medical ResearchOTHER_GOV
67 Previous Clinical Trials
135,127 Total Patients Enrolled
Sarah Averbach, MD, MASPrincipal InvestigatorUniversity of California, San Diego
3 Previous Clinical Trials
444 Total Patients Enrolled

Media Library

PIVoT Clinical Trial Eligibility Overview. Trial Name: NCT05732142 — N/A
Birth Control Research Study Groups: PIVoT, Standard of care
Birth Control Clinical Trial 2023: PIVoT Highlights & Side Effects. Trial Name: NCT05732142 — N/A
PIVoT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05732142 — N/A
~34 spots leftby Feb 2025
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