Vaccination RefusalADEPTNCT05795855
An Adaptive Prenatal Intervention to Increase Childhood Vaccinations
A study testing ADEPT in people with Vaccination Refusal, run by Emory University at 1 site in United States.
Trial summary
This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build confidence in vaccinations and lead to timely vaccinations during pregnancy and once their child is born. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccination Refusal
- What is being tested?
- ADEPT
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nulliparous individuals (no prior live birth)
- Singleton pregnancy (excludes twins, triplets, etc.)
- No known fetal congenital malformations or genetic abnormalities
- Not at known risk for preterm birth
- In late second trimester during study recruitment period
- Receive prenatal care at one of the study practices
Show all 12Show fewer
- Eligible to receive adaptive components of ADEPT (vaccine-hesitant after provider recommendation)
- At least 18 years of age
- Provide informed consent
- Agree to participate in surveys and in-depth interview
- Agree for child's vaccination outcomes to be extracted from the North Carolina Immunization Registry (NCIR)
- Plan to stay in North Carolina for at least 3 months after delivery
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build confidence in vaccinations and lead to timely vaccinations during pregnancy and once their child is born.
Read the detailed description
In the United States (US), parents' decision to delay or refuse vaccines for their children has resulted in pockets of under-vaccination as well as recurring outbreaks of vaccine-preventable diseases. To increase childhood vaccinations and stem recurring outbreaks, there is a need for effective interventions that build parents' confidence in vaccines and reduce their vaccine hesitancy. The first recommended routine vaccination for children is due at birth. Yet, many parents lack timely or evidence-based information on childhood vaccinations prior to their child's birth. Hence, the researchers of this study propose to evaluate ADEPT - an adaptive intervention that is implemented in prenatal care settings to proactively connect expectant parents with evidence-based information on vaccines recommended during pregnancy and for children after birth. The core component of ADEPT includes prenatal provider trainings and a recommendation to pregnant individuals encouraging vaccinations during pregnancy and for children after birth. Those pregnant individuals who remain vaccine-hesitant despite the provider recommendation will receive adaptive intervention components, which include evidence-based educational materials on vaccinations and phone consultations with a vaccine navigator to discuss any residual concerns.
In the proposed study, ADEPT will be implemented and evaluated in diverse prenatal care practices in North Carolina. Study prenatal care practices will be randomized to the ADEPT intervention or standard of care to pregnant individuals. Individuals receiving prenatal care at a clinic implementing ADEPT will be screened for vaccination intention following the provider recommendation. Vaccine-hesitant pregnant individuals will be offered enrollment into a nested sub-study designed to assess the implementation of the ADEPT intervention. After the pregnant individuals in the intervention and control arms give birth, the researchers will assess their children's vaccination outcomes at birth, 2, 4, 6, and 12 months using data from the North Carolina Immunization Registry (NCIR). The primary study outcome is the difference in timely childhood vaccination at 2 months between the intervention and control arms. In addition, maternal vaccination data will be collected from NCIR for vaccines during pregnancy.
- Conditions
- Vaccination Refusal
- Being tested
- ADEPT
- Keywords
- Vaccine hesitancy
- Medical subject headings
- Vaccination Refusal, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADEPTBehavioural
Prenatal providers will participate in trainings that will lay the foundation for an effective vaccination recommendation. After the completion of training, prenatal care providers will begin making recommendations promoting the importance of maternal and childhood vaccinations to pregnant individuals, as part of routine prenatal care. The core component of ADEPT is prenatal provider training to enable a vaccination recommendation, encouraging pregnant individuals to receive vaccines during pregnancy and for their child after birth. Pregnant individuals who remain vaccine hesitant despite the provider recommendation, will be eligible to receive the adaptive components of ADEPT in the form of evidence-based educational materials on vaccinations and phone consultations with a vaccine navigator to discuss residual concerns.
| Study group | Role | What they receive |
|---|---|---|
| ADEPT | Experimental | Individuals receiving prenatal care at a practice that was randomized to deliver the ADEPT intervention. Receives: Behavioral: ADEPT |
| Standard of Care | No intervention | Individuals receiving prenatal care at a practice that was randomized to deliver the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children receiving timely vaccinations
The proportion of children who receive vaccinations per the Advisory Committee on Immunization Practices (ACIP) recommended schedule at 2 months-post birth, by study arm.
Measured: 2 months post birth
Secondary outcomes (1)
Change in Vaccine Hesitancy
In the intervention arm only, vaccine hesitancy will be examined among pregnant individuals in the intervention prenatal practices. When asked about vaccination intention, lack of intention to get vaccinations during pregnancy or for their child after birth will determine if they will receive the adaptive portion of ADEPT. The question will be asked again following completion of the ADEPT adaptive components.
Measured: 28-32 weeks gestation (after receiving the core ADEPT intervention), following completion of the adaptive portion of ADEPT (prior to birth, typically 40 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start27 Apr 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Why it stopped: The study is suspended pending a protocol amendment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccination RefusalStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lavanya Vasudevan, Emory University
- Investigators
- Lavanya Vasudevan, PhD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795855
- Sponsor's protocol ID
- STUDY00005432
- Other IDs
- STUDY00005431, U01IP001149, STUDY00005457
- Acronym
- ADEPT
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets related to the primary outcome will be made available after deidentification.
Publications
Vasudevan L, Porter RM, Campos I, Turner EL, Stinnett SS, Zullig LL, Walter EB, Swamy GK, Bednarczyk RA, Orenstein WA, Gray B. An ADaptivE PrenaTal (ADEPT) intervention to increase childhood vaccinations: Protocol for a cluster randomized trial and nested mixed methods evaluation. PLoS One. 2024 Nov 21;19(11):e0313742. doi: 10.1371/journal.pone.0313742. eCollection 2024.
PubMed 39570957
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Prenatal Intervention to Increase Childhood Vaccinations
- ClinicalTrials.gov ID
- NCT05795855
- Acronym / sponsor ID
- ADEPT / STUDY00005432
- Conditions
- Vaccination Refusal
- Keywords
- Vaccine hesitancy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study is suspended pending a protocol amendment.
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build confidence in vaccinations and lead to timely vaccinations during pregnancy and once their child is born.
Detailed description
In the United States (US), parents' decision to delay or refuse vaccines for their children has resulted in pockets of under-vaccination as well as recurring outbreaks of vaccine-preventable diseases. To increase childhood vaccinations and stem recurring outbreaks, there is a need for effective interventions that build parents' confidence in vaccines and reduce their vaccine hesitancy. The first recommended routine vaccination for children is due at birth. Yet, many parents lack timely or evidence-based information on childhood vaccinations prior to their child's birth. Hence, the researchers of this study propose to evaluate ADEPT - an adaptive intervention that is implemented in prenatal care settings to proactively connect expectant parents with evidence-based information on vaccines recommended during pregnancy and for children after birth. The core component of ADEPT includes prenatal provider trainings and a recommendation to pregnant individuals encouraging vaccinations during pregnancy and for children after birth. Those pregnant individuals who remain vaccine-hesitant despite the provider recommendation will receive adaptive intervention components, which include evidence-based educational materials on vaccinations and phone consultations with a vaccine navigator to discuss any residual concerns.
In the proposed study, ADEPT will be implemented and evaluated in diverse prenatal care practices in North Carolina. Study prenatal care practices will be randomized to the ADEPT intervention or standard of care to pregnant individuals. Individuals receiving prenatal care at a clinic implementing ADEPT will be screened for vaccination intention following the provider recommendation. Vaccine-hesitant pregnant individuals will be offered enrollment into a nested sub-study designed to assess the implementation of the ADEPT intervention. After the pregnant individuals in the intervention and control arms give birth, the researchers will assess their children's vaccination outcomes at birth, 2, 4, 6, and 12 months using data from the North Carolina Immunization Registry (NCIR). The primary study outcome is the difference in timely childhood vaccination at 2 months between the intervention and control arms. In addition, maternal vaccination data will be collected from NCIR for vaccines during pregnancy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADEPT | Experimental | Behavioral: ADEPTIndividuals receiving prenatal care at a practice that was randomized to deliver the ADEPT intervention. |
| Standard of Care | No intervention | –Individuals receiving prenatal care at a practice that was randomized to deliver the standard of care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Nulliparous individuals (no prior live birth)
- Singleton pregnancy (excludes twins, triplets, etc.)
- No known fetal congenital malformations or genetic abnormalities
- Not at known risk for preterm birth
- In late second trimester during study recruitment period
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADEPTPrenatal providers will participate in trainings that will lay the foundation for an effective vaccination recommendation. After the completion of training, prenatal care providers will begin making recommendations promoting the importance of maternal and childhood vaccinations to pregnant individuals, as part of routine prenatal care. The core component of ADEPT is prenatal provider training to enable a vaccination recommendation, encouraging pregnant individuals to receive vaccines during pregnancy and for their child after birth. Pregnant individuals who remain vaccine hesitant despite the provider recommendation, will be eligible to receive the adaptive components of ADEPT in the form of evidence-based educational materials on vaccinations and phone consultations with a vaccine navigator to discuss residual concerns. | Behavioural | ADEPT |
Primary outcome
Proportion of children receiving timely vaccinations
Time frame: 2 months post birth
The proportion of children who receive vaccinations per the Advisory Committee on Immunization Practices (ACIP) recommended schedule at 2 months-post birth, by study arm.
1 secondary outcome
Change in Vaccine Hesitancy
Time frame: 28-32 weeks gestation (after receiving the core ADEPT intervention), following completion of the adaptive portion of ADEPT (prior to birth, typically 40 weeks gestation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 39570957Vasudevan L, Porter RM, Campos I, Turner EL, Stinnett SS, Zullig LL, Walter EB, Swamy GK, Bednarczyk RA, Orenstein WA, Gray B. An ADaptivE PrenaTal (ADEPT) intervention to increase childhood vaccinations: Protocol for a cluster randomized trial and nested mixed methods evaluation. PLoS One. 2024 Nov 21;19(11):e0313742. doi: 10.1371/journal.pone.0313742. eCollection 2024.
- Individual participant dataSharing planned: Yes. Datasets related to the primary outcome will be made available after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lavanya Vasudevan, PhD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADEPT in people with Vaccination Refusal, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children receiving timely vaccinations (time frame: 2 months post birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05795855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.