Clinical trial NCT04421586: VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy
Official title: VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination Uptake
Keywords: vaccine hesitancy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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.

Primary outcomes:
measure: Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm
timeFrame: Post-counseling (Baseline visit)
Secondary outcomes:
measure: Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.
timeFrame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
measure: Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
timeFrame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
measure: Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
timeFrame: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
measure: Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm
timeFrame: Baseline
measure: Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again
timeFrame: Baseline
measure: Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family
timeFrame: Baseline
Other outcomes:
Locations:
city: Mtwara
country: Tanzania
facility: National Institute for Medical Research (NIMR)
Study officials:
affiliation: Duke University
name: Lavanya Vasudevan, PhD
role: PRINCIPAL_INVESTIGATOR
References: