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

Duke University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Vaccination Uptake

Interventions

VISTABEHAVIORAL

VISTA will be an educational intervention.

Eligibility

Sex: ALLMin age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Exclusion Criteria: There are no exclusion criteria.

Locations (1)

National Institute for Medical Research (NIMR)

Mtwara, Tanzania

Outcomes

Primary Outcomes

Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm

Time frame: Post-counseling (Baseline visit)

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

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.

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

Data from ClinicalTrials.gov

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