N/A N=60 Health Services Research

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

Vaccination Uptake

Bottom Line

View on ClinicalTrials.gov: NCT04421586 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm — 51.72 percentage of women

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: VISTA (Behavioral)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Duke University
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm	51.72	—
SECONDARY Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.	48.0; 62.5	—
SECONDARY Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm	96.00; 86.96; 88.00; 82.61; 64.00; 73.91	—
SECONDARY Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm	6.5; 12; 6; 8.5; 5; 3	—
SECONDARY Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm	90.17	—
SECONDARY Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm	15.86	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful	28	—
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	24	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines	26	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions	—	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful	28	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand	27	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)	28	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child	29	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again	28	—
SECONDARY Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family	28	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04421586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.