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

NCT04421586 | Completed Results

• 1 other identifier: Pro00100032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination Uptake

Keywords

vaccine hesitancy

Outcome Measures

Primary Outcomes (1)

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

  Post-counseling (Baseline visit)

Secondary Outcomes (15)

• 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

  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

Study Arms (2)

Pregnant women receiving VISTA counseling

EXPERIMENTAL

Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA

Behavioral: VISTA

Pregnant women receiving usual care

NO INTERVENTION

Up to 30 pregnant women receiving usual care

Interventions

VISTA BEHAVIORAL

VISTA will be an educational intervention.

Pregnant women receiving VISTA counseling

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

National Institute for Medical Research (NIMR)

Mtwara, Tanzania

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Vaccination data for one child in the usual care group was uninterpretable, hence, excluded from assessment of vaccination timeliness outcomes.

Results Point of Contact

• Title: Lavanya Vasudevan, Ph.D.
• Organization: Duke University

lavanya.vasudevan@duke.edu

919-613-1423

Study Officials

• Lavanya Vasudevan, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: September 2, 2020
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)