VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy

NCT ID: NCT04421586

Last Updated: 2024-01-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2021-05-24

Brief Summary

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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

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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

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Vaccination Uptake

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pregnant women receiving VISTA counseling

Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA

Group Type EXPERIMENTAL

VISTA

Intervention Type BEHAVIORAL

VISTA will be an educational intervention.

Pregnant women receiving usual care

Up to 30 pregnant women receiving usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VISTA

VISTA will be an educational intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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:

* 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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lavanya Vasudevan, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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National Institute for Medical Research (NIMR)

Mtwara, , Tanzania

Site Status

Countries

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Tanzania

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00100032

Identifier Type: -

Identifier Source: org_study_id

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