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

Not Applicable

Completed

• Conditions: Vaccination Uptake
• Interventions: Behavioral: VISTA

• Registration Number: NCT04421586
• Lead Sponsor: Duke University

Brief 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-09-02
• Primary Completion: 2021-05-24
• Study Completion: 2021-05-24
• Results First Submitted: 2022-05-23
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-20
• Results First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

There are no exclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregnant women receiving VISTA counseling	VISTA	Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA

Primary Outcome Measures

Name	Time	Method
Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm	Post-counseling (Baseline visit)

Secondary Outcome Measures

Name	Time	Method
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm	Follow-up (up to 6 months post-birth; up to 9 months post-baseline)	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.
Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful	Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful	Baseline
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm	Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm	Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand	Baseline
Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm	Baseline
Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)	Baseline
Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.	Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines	Baseline
Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family	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	Baseline
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions	Baseline
Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child	Baseline
Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again	Baseline

Trial Locations

Locations (1)

National Institute for Medical Research (NIMR); 🇹🇿 Mtwara, Tanzania