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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vaccination Uptake

Intervention / Treatment
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* Behavioral: VISTA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women receiving VISTA counseling<br>Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA | Behavioral: VISTA<br>* VISTA will be an educational intervention.<br>|
| No Intervention: Pregnant women receiving usual care<br>Up to 30 pregnant women receiving usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women with reduced number of concerns immediately post-counseling in the intervention arm |  | Post-counseling (Baseline visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women with reduced number of concerns in intervention versus control arms at follow up. |  | Follow-up (up 6-months post-birth) | 
| Percentage of children by vaccine who received the vaccine within 4-week window of due date in intervention versus control arm |  | Follow-up (up 6-months post-birth) | 
| Mean number of days children remain unvaccinated for each vaccine in intervention versus control arm |  | Follow-up (up 6-months post-birth) | 
| Median number of days children remain unvaccinated for each vaccine in intervention versus control arm |  | Follow-up (up 6-months post-birth) | 
| Percentage of checklist items completed during counseling in intervention arm. |  | Baseline | 
| Mean number of minutes spent delivering counseling per woman in intervention arm |  | Baseline | 
| Percentage of women in the intervention arm who say that the information provided by the community health worker (CHW) is helpful |  | Baseline | 
| Percentage of women in the intervention arm who say that the information provided by the community health worker (CHW) reduced their concerns about vaccinations |  | Baseline | 
| Percentage of women in the intervention arm who say that the community health worker (CHW) helped them understand why children needed vaccines |  | Baseline | 
| Percentage of women in the intervention arm who say that the community health worker (CHW) answered most of their questions |  | Baseline | 
| Percentage of women in the intervention arm who say that the community health worker (CHW) was respectful |  | Baseline | 
| Percentage of women in the intervention arm who say that the community health worker (CHW) explained things in terms they could understand |  | Baseline | 
| Percentage of women in the intervention arm who were satisfied with their conversation with the community health worker (CHW) |  | Baseline | 
| Percentage of women in the intervention arm who say they are comfortable vaccinating their child |  | Baseline | 
| Percentage of women in the intervention arm who say they will speak with the CHW again |  | Baseline | 
| Percentage of women in the intervention arm who say they would refer the CHW to their friends and family |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine hesitancy