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

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.

Study Overview

• Status: Completed
• Conditions: Vaccination Uptake
• Intervention / Treatment: Behavioral: VISTA

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Mtwara, Tanzania
    • National Institute for Medical Research (NIMR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant women receiving VISTA counseling; Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA	Behavioral: VISTA; VISTA will be an educational intervention.
No Intervention: Pregnant women receiving usual care; Up to 30 pregnant women receiving usual care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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.	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		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		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 Information Provided by the Community Health Worker (CHW) is Helpful		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) Helped Them Understand Why Children Needed Vaccines		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 That the Community Health Worker (CHW) Was Respectful		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
Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)		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
Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family		Baseline

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Lavanya Vasudevan, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): May 24, 2021
• Study Completion (Actual): May 24, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: vaccine hesitancy
• Other Study ID Numbers: Pro00100032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No