Vaccination UptakeNCT04421586
VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy
A study testing VISTA in people with Vaccination Uptake, run by Duke University at 1 site in Tanzania.
Trial summary
The purpose of this study is to understand why parents do or do not vaccinate their children and explore what information parents need to vaccinate their children. The study will test whether information about vaccinations provided during pregnancy by a health provider (VISTA intervention) may improve the possibility… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Uptake
- What is being tested?
- VISTA
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTanzania
- Study dates
- 2 Sep 2020to 24 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Study outcomes will be measured for health providers implementing the intervention and pregnant women receiving the intervention. Up to 10 health workers (including community health workers (CHW) from each of the intervention sites will participate in the study.
- To participate in the study,
- Health workers must be:
- 18 years of age or older
- Work in one of the study intervention sites
- Women must be:
Show all 11Show fewer
- In the third trimester of pregnancy
- Residing in a study site (intervention or control)
- At least 15 years of age
- Planning to reside in the study site for the duration of their participation in the study (until approximately 6 months after delivery to enable follow up).
- Have at least 1 concern about childhood vaccines
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to understand why parents do or do not vaccinate their children and explore what information parents need to vaccinate their children. The study will test whether information about vaccinations provided during pregnancy by a health provider (VISTA intervention) may improve the possibility that a child is vaccinated on time.
Read the detailed description
The study will be implemented in 10 health facility catchment areas in Mtwara region, Tanzania. The study sites will be non-randomly assigned to receive VISTA or usual care.
Only core messages were developed and evaluated in this study. Tailored messages will be developed and evaluated in a follow-up study.
- Conditions
- Vaccination Uptake
- Being tested
- VISTA
- Keywords
- vaccine hesitancy
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISTABehavioural
VISTA will be an educational intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women receiving VISTA counseling | Experimental | Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA Receives: Behavioral: VISTA |
| Pregnant women receiving usual care | No intervention | Up to 30 pregnant women receiving usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm
Measured: Post-counseling (Baseline visit)
Secondary outcomes (15)
Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.
Measured: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
Includes early doses up to 1 week prior to due date. In the event of twins, information for only 1 child per mother was included in the determination of outcomes.
Measured: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
Measured: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm
Measured: Baseline
Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) Reduced Their Concerns About Vaccinations
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again
Measured: Baseline
Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start2 Sep 2020
- Primary completion24 May 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaccination UptakeStudies of the same condition, open and under way.
- More trials run by Duke 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lavanya Vasudevan, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421586
- Sponsor's protocol ID
- Pro00100032
- Status last verified
- Mar 2023
- First submitted
- 4 Jun 2020
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy
- ClinicalTrials.gov ID
- NCT04421586
- Acronym / sponsor ID
- Pro00100032
- Conditions
- Vaccination Uptake
- Keywords
- vaccine hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand why parents do or do not vaccinate their children and explore what information parents need to vaccinate their children. The study will test whether information about vaccinations provided during pregnancy by a health provider (VISTA intervention) may improve the possibility that a child is vaccinated on time.
Detailed description
The study will be implemented in 10 health facility catchment areas in Mtwara region, Tanzania. The study sites will be non-randomly assigned to receive VISTA or usual care.
Only core messages were developed and evaluated in this study. Tailored messages will be developed and evaluated in a follow-up study.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women receiving VISTA counseling | Experimental | Behavioral: VISTAUp to 30 pregnant women are screened and counseled for vaccine concerns using VISTA |
| Pregnant women receiving usual care | No intervention | –Up to 30 pregnant women receiving usual care |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Study outcomes will be measured for health providers implementing the intervention and pregnant women receiving the intervention. Up to 10 health workers (including community health workers (CHW) from each of the intervention sites will participate in the study.
- To participate in the study,
- 18 years of age or older
- Work in one of the study intervention sites
- In the third trimester of pregnancy
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
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 |
|---|---|---|
| VISTAVISTA will be an educational intervention. | Behavioural | Pregnant women receiving VISTA counseling |
Primary outcome
Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm
Time frame: Post-counseling (Baseline visit)
15 secondary outcomes
Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.
Time frame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
Time frame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
Time frame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm
Time frame: Baseline
Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) Reduced Their Concerns About Vaccinations
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again
Time frame: Baseline
Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 principal investigator
Duke 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 VISTA in people with Vaccination Uptake, run by Duke University at 1 site in Tanzania.
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 11 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: finished, as of the sponsor's last update on 5 Jan 2024. 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 Tanzania. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm (time frame: Post-counseling (Baseline visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.