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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women receiving VISTA counseling | Experimental | Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA |
|
| Pregnant women receiving usual care | No Intervention | Up to 30 pregnant women receiving usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VISTA | Behavioral | VISTA will be an educational intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm | Post-counseling (Baseline visit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Women must be:
Exclusion Criteria:
There are no exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Lavanya Vasudevan, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Medical Research (NIMR) | Mtwara | Tanzania |
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Participants recruited from medical clinics and surrounding communities in rural areas.
| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant Women Receiving VISTA Counseling | Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA (Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy) VISTA: VISTA will be an educational intervention. |
| FG001 | Pregnant Women Receiving Usual Care | Up to 30 pregnant women receiving usual care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants on whom baseline/demographic data was collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Women Receiving VISTA Counseling | Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA (Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy) VISTA: VISTA will be an educational intervention. |
| BG001 | Pregnant Women Receiving Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm | Outcome measure only applies to the VISTA arm. | Posted | Number | percentage of women | Post-counseling (Baseline visit) |
|
Follow-up (up to 6 months post-birth; up to 9 months post-baseline)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnant Women Receiving VISTA Counseling | Up to 30 pregnant women are screened and counseled for vaccine concerns using VISTA (Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy) VISTA: VISTA will be an educational intervention. |
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Vaccination data for one child in the usual care group was uninterpretable, hence, excluded from assessment of vaccination timeliness outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lavanya Vasudevan, Ph.D. | Duke University | 919-613-1423 | lavanya.vasudevan@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2021 | May 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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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.
| 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 |
| Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful | Baseline |
| 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 | Baseline |
| Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines | Baseline |
| Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions | Baseline |
| Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful | Baseline |
| Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand | Baseline |
| Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW) | Baseline |
| Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child | Baseline |
| Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again | Baseline |
| Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family | Baseline |
| Withdrawn by PI |
|
| Infant death (no follow up data or vaccination outcomes) |
|
Up to 30 pregnant women receiving usual care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up. | Data not collected on 6 participants in each group. | Posted | Number | percentage of women | Follow-up (up to 6 months post-birth; up to 9 months post-baseline) |
|
|
|
| Secondary | Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm | 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. | Data not collected on 13 participants. | Posted | Number | percentage of children | Follow-up (up to 6 months post-birth; up to 9 months post-baseline) |
|
|
|
| Secondary | Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm | Data not collected on 13 participants. | Posted | Median | Full Range | days | Follow-up (up to 6 months post-birth; up to 9 months post-baseline) |
|
|
|
| Secondary | Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm | Outcome measure only applies to the VISTA arm. | Posted | Mean | Full Range | percentage of items | Baseline |
|
|
|
| Secondary | Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm | Outcome measure only applies to the VISTA arm. | Posted | Mean | Full Range | minutes | Baseline |
|
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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 | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Answered Most of Their Questions | Data not collected. | Posted | Baseline |
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW) | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family | Outcome measure only applies to the VISTA arm. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Pregnant Women Receiving Usual Care | Up to 30 pregnant women receiving usual care | 1 | 30 | 0 | 30 | 0 | 30 |
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| D001519 | Behavior |
| Polio 1 |
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| Polio 2 |
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| Polio 3 (OPV3/IPV) |
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| DTP 1 |
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| DTP 2 |
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| DTP 3 |
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| PCV 1 |
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| PCV 2 |
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| PCV 3 |
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| RTR 1 |
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| RTR 2 |
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| Polio 1 |
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| Polio 2 |
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| Polio 3 |
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| Polio IPV |
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| DTP 1 |
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| DTP 2 |
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| DTP 3 |
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| PCV 1 |
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| PCV 2 |
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| PCV 3 |
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| RTR 1 |
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| RTR 2 |
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