Skip to main content
OpenTrials
Completed

NCT Number: NCT04421586

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaccination Uptake Behavior Health Behavior Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Medical Research (NIMR)

Mtwara, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VISTA

Behavioral

VISTA will be an educational intervention.

Primary outcomes

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

    Time frame: Post-counseling (Baseline visit)

Secondary outcomes

  1. Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.

    Time frame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)

  2. Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm

    Time frame: 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.

  3. Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm

    Time frame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)

  4. Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm

    Time frame: Baseline

  5. Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm

    Time frame: Baseline

  6. Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful

    Time frame: Baseline

  7. 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

    Time frame: Baseline

  8. Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines

    Time frame: Baseline

  9. Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions

    Time frame: Baseline

  10. Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful

    Time frame: Baseline

  11. Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand

    Time frame: Baseline

  12. Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)

    Time frame: Baseline

  13. Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child

    Time frame: Baseline

  14. Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again

    Time frame: Baseline

  15. Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.