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

Vaccination Uptake Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421586
• Other study ID #: Pro00100032
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: May 24, 2021

Study information

• Verified date: March 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 that a child is vaccinated on time.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 24, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaccination Uptake

Intervention

Behavioral:
• VISTA
VISTA will be an educational intervention.

Locations

Country	Name	City	State
Tanzania	National Institute for Medical Research (NIMR)	Mtwara

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm		Post-counseling (Baseline visit)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm		Baseline
Secondary	Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm		Baseline
Secondary	Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful		Baseline
Secondary	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
Secondary	Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines		Baseline
Secondary	Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions		Baseline
Secondary	Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful		Baseline
Secondary	Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand		Baseline
Secondary	Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)		Baseline
Secondary	Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child		Baseline
Secondary	Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again		Baseline
Secondary	Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family		Baseline