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NCT04302675 · ClinicalTrials.gov registry record · NA
Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 1,350
- Enrollment target
NCT04302675: Completed NA study, sponsored by University of Colorado, Denver.
NCT04302675 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 1,350 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04302675, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,350 participants
- Enrollment target
Study Summary
Vaccinating pregnant women affords a unique opportunity to protect both mother and child against influenza and pertussis, yet uptake of maternal immunizations remain far below national target goals. A significant barrier to vaccine uptake is the lack of evidence to guide provider communication with patients who have concerns about vaccines. This novel study will adapt motivational interviewing to the ob-gyn setting to provide information about how to improve provider communication and increase vaccine uptake among pregnant women. The investigators propose a pragmatic practice-based study in 5 ob-gyn practices in Colorado to develop the MI for maternal immunizations (MI4MI) intervention and assess fidelity, acceptability, and feasibility among patients and providers. Aim 1 will use an iterative process building upon existing knowledge of patient concerns about maternal immunizations and our prior experience training providers in Motivational Interviewing (MI) for childhood immunizations to develop the MI4MI training. During development, the study team will conduct focus groups to elicit provider input during. The MI4MI intervention will include a video-module, 2 asynchronous online trainings, provider reference sheets, and practice study champions. Aim 2 will include intervention implementation and assessment of intervention fidelity, acceptability, and feasibility. In Aim 2a, will conduct pre- and post-intervention chart reviews among participating practices to evaluate the impact of MI4MI on influenza and Tdap vaccine uptake among pregnant patients.
Primary Outcome
Based on the success of our MI program for vaccine hesitancy among parents of adolescents, we will use an iterative process \[incorporating organizational perspectives and\] provider feedback through focus groups to develop a multifaceted provider training program for using MI to encourage maternal immunization acceptance among women with concerns about vaccines. We will build upon existing knowledge of patient concerns to develop training in MI techniques with specific strategies to apply to ma
Interventions
- BEHAVIORAL Prevention, Maternal Immunization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,350 participants |
| Start Date | 2020-05-27 |
| Est. Completion | 2022-06-30 |
| Phase | NA |
What the finished NCT04302675 record still lists
NCT04302675 is an interventional study that assigns participants to a tested intervention. Its 1,350 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Prevention, Maternal Immunization is the first listed.
NCT04302675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04302675 about?
NCT04302675 is a clinical study titled "Adapting Motivational Interviewing for Maternal Immunizations (MI4MI)". Vaccinating pregnant women affords a unique opportunity to protect both mother and child against influenza and pertussis, yet uptake of maternal immunizations remain far below national target goals. A significant barrier to vaccine uptake is the lack of evidence to guide provider communication with ...
What is the current status of trial NCT04302675?
This trial is currently completed. It is a NA study. The enrollment target is 1,350 participants. The study started on 2020-05-27. Estimated completion is 2022-06-30.
What interventions are being tested in trial NCT04302675?
The interventions under investigation include: Prevention, Maternal Immunization (BEHAVIORAL).
Who is sponsoring clinical trial NCT04302675?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04302675's enrollment target sits among peer trials
1,350 73rd of 2000 higher than 1,927 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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