Trial Outcomes & Findings for VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy (NCT NCT04421586)
NCT ID: NCT04421586
Last Updated: 2024-01-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Post-counseling (Baseline visit)
Results posted on
2024-01-05
Participant Flow
Participants recruited from medical clinics and surrounding communities in rural areas.
Unit of analysis: study sites
Participant milestones
| Measure |
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Overall Study
STARTED
|
30 5
|
30 5
|
|
Overall Study
COMPLETED
|
25 5
|
24 5
|
|
Overall Study
NOT COMPLETED
|
5 0
|
6 0
|
Reasons for withdrawal
| Measure |
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawn by PI
|
1
|
0
|
|
Overall Study
Infant death (no follow up data or vaccination outcomes)
|
2
|
3
|
Baseline Characteristics
VISTA: Vaccinator-Initiated Screening and TAilored Counseling for Reducing Vaccine Hesitancy
Baseline characteristics by cohort
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
n=30 Participants
Up to 30 pregnant women receiving usual care
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.28 years
STANDARD_DEVIATION 7.04 • n=5 Participants
|
28.10 years
STANDARD_DEVIATION 8.38 • n=7 Participants
|
29.66 years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Tanzania
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-counseling (Baseline visit)Population: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Percentage of Women With Reduced Number of Concerns Immediately Post-counseling in the Intervention Arm
|
51.72 percentage of women
|
—
|
SECONDARY outcome
Timeframe: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)Population: Data not collected on 6 participants in each group.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=25 Participants
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.
|
Pregnant Women Receiving Usual Care
n=24 Participants
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Percentage of Women With Reduced Number of Concerns in Intervention Versus Control Arms at Follow up.
|
48.0 percentage of women
|
62.5 percentage of women
|
SECONDARY outcome
Timeframe: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)Population: Data not collected on 13 participants.
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.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=25 Participants
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.
|
Pregnant Women Receiving Usual Care
n=23 Participants
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
BCG
|
96.00 percentage of children
|
86.96 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
Polio 1
|
64.00 percentage of children
|
73.91 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
Polio 2
|
48.00 percentage of children
|
56.52 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
DTP 3
|
84.00 percentage of children
|
69.57 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
PCV 2
|
88.00 percentage of children
|
78.26 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
PCV 3
|
84.00 percentage of children
|
60.87 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
RTR 1
|
76.00 percentage of children
|
78.00 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
RTR 2
|
72.00 percentage of children
|
69.57 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
Polio 0
|
88.00 percentage of children
|
82.61 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
Polio 3 (OPV3/IPV)
|
68.00 percentage of children
|
60.87 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
DTP 1
|
100.00 percentage of children
|
95.65 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
DTP 2
|
96.00 percentage of children
|
86.96 percentage of children
|
|
Percentage of Children by Vaccine Who Received the Vaccine Within 4-week Window of Due Date in Intervention Versus Control Arm
PCV 1
|
92.00 percentage of children
|
86.96 percentage of children
|
SECONDARY outcome
Timeframe: Follow-up (up to 6 months post-birth; up to 9 months post-baseline)Population: Data not collected on 13 participants.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=25 Participants
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.
|
Pregnant Women Receiving Usual Care
n=23 Participants
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
BCG
|
6.5 days
Interval 0.0 to 32.0
|
12 days
Interval 2.0 to 46.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
Polio 0
|
6 days
Interval 0.0 to 12.0
|
8.5 days
Interval 0.0 to 33.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
Polio 1
|
5 days
Interval -3.0 to 141.0
|
3 days
Interval -2.0 to 31.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
Polio 2
|
8 days
Interval 1.0 to 78.0
|
13 days
Interval 4.0 to 40.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
Polio 3
|
19 days
Interval 9.0 to 51.0
|
14 days
Interval 7.0 to 61.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
Polio IPV
|
15 days
Interval 5.0 to 59.0
|
19.5 days
Interval 4.0 to 34.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
DTP 1
|
3 days
Interval -3.0 to 24.0
|
3 days
Interval -2.0 to 31.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
DTP 2
|
9.5 days
Interval 1.0 to 59.0
|
12 days
Interval 1.0 to 40.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
DTP 3
|
14.5 days
Interval 5.0 to 59.0
|
17 days
Interval 4.0 to 61.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
PCV 1
|
3 days
Interval -3.0 to 24.0
|
4 days
Interval -2.0 to 31.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
PCV 2
|
9.5 days
Interval 1.0 to 59.0
|
13 days
Interval 1.0 to 40.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
PCV 3
|
14.5 days
Interval 5.0 to 59.0
|
17 days
Interval 4.0 to 61.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
RTR 1
|
5 days
Interval -3.0 to 41.0
|
5 days
Interval -2.0 to 58.0
|
|
Median Number of Days Children Remain Unvaccinated for Each Vaccine in Intervention Versus Control Arm
RTR 2
|
20.5 days
Interval 1.0 to 59.0
|
12 days
Interval 1.0 to 40.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Percentage of Checklist Items Completed During Counseling in VISTA Intervention Arm
|
90.17 percentage of items
Interval 70.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Mean Number of Minutes Spent Delivering Counseling Per Woman in VISTA Intervention Arm
|
15.86 minutes
Interval 10.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Number of Women in the VISTA Intervention Arm Who Say That the Information Provided by the Community Health Worker (CHW) is Helpful
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
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
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Helped Them Understand Why Children Needed Vaccines
|
26 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Was Respectful
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Number of Women in the VISTA Intervention Arm Who Say That the Community Health Worker (CHW) Explained Things in Terms They Could Understand
|
27 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Number of Women in the VISTA Intervention Arm Who Were Satisfied With Their Conversation With the Community Health Worker (CHW)
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Number of Women in the VISTA Intervention Arm Who Say They Are Comfortable Vaccinating Their Child
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Number of Women in the VISTA Intervention Arm Who Say They Will Speak With the CHW Again
|
28 Participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Outcome measure only applies to the VISTA arm.
Outcome measures
| Measure |
Pregnant Women Receiving VISTA Counseling
n=29 Participants
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.
|
Pregnant Women Receiving Usual Care
Up to 30 pregnant women receiving usual care
|
|---|---|---|
|
Number of Women in the VISTA Intervention Arm Who Say They Would Refer the CHW to Their Friends and Family
|
28 Participants
|
—
|
Adverse Events
Pregnant Women Receiving VISTA Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pregnant Women Receiving Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place