Covid19, Vaccine Refusal
Conditions
Keywords
Community Health Worker
Brief summary
The purpose of the study is to assess the effectiveness of the HALT COVID Ambassador educational outreach program on increasing likelihood to vaccinate against COVID-19
Detailed description
Investigators will use a randomized controlled trial to test the effectiveness of HALT COVID educational outreach by HALT COVID Ambassadors. HALT COVID Ambassadors will receive training to answer common vaccine questions & address misconceptions; conduct motivational interviewing; and implement basic behavioral economics and related strategies to remove barriers to vaccination. A random sample of FQHC patients will be identified in EHR data downloads of adult patients seen in the last year and contacted by telephone to gain consent and assess eligibility. A total of 100 individuals will be enrolled into the trial and randomized to intervention (engagement with the HALT COVID Ambassador over a 1 month period via in-person or virtual sessions exploring their own questions and concerns about vaccines) or usual care (no extra engagement). Baseline, 1-month, and 2-month follow-up surveys will assess for vaccine likelihood.
Interventions
BEHAVIORALCommunity health worker engagement
3-4 in-person or virtual engagements (individual or group sessions) over 1 month, each engagement lasting 30 minutes to 1 hour
Sponsors
National Institutes of Health (NIH)
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Unlikely to vaccinate in next month * Age \>=18 years * Self-identification as Black or African American * Ability to understand and speak English * Willingness to engage with HALT COVID Ambassador via in-person or virtual sessions exploring questions and concerns about vaccines
Exclusion criteria
* Unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Proportion of Participants Likely to Vaccinate Between Study Arms at Month 1 | Month 1 follow-up | Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?), with likely to vaccinate defined as a score of 5-7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Proportion of Participants Likely to Vaccinate Between Study Arms at Month 2 | Month 2 follow-up | Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?), with likely to vaccinate defined as a score of 5-7. |
| Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 1 | Month 1 follow-up | Receipt of vaccination will be measured by self-report |
| Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 2 | Month 2 follow-up | Receipt of vaccination will be measured by self-report |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Community health worker engagement: 3-4 in-person or virtual engagements (individual or group sessions) over 1 month, each engagement lasting 30 minutes to 1 hour | 27 |
| Usual Care No intervention | 29 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 5 |
Baseline characteristics
| Characteristic | Intervention | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 41.2 years STANDARD_DEVIATION 13.4 | 42.7 years STANDARD_DEVIATION 13.4 | 44.1 years STANDARD_DEVIATION 13.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 53 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 participants | 56 participants | 29 participants |
| Sex/Gender, Customized Men | 6 Participants | 14 Participants | 8 Participants |
| Sex/Gender, Customized Women | 21 Participants | 42 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 29 |
| other Total, other adverse events | 0 / 27 | 0 / 29 |
| serious Total, serious adverse events | 0 / 27 | 0 / 29 |
Outcome results
Primary
Difference in Proportion of Participants Likely to Vaccinate Between Study Arms at Month 1
Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?), with likely to vaccinate defined as a score of 5-7.
Time frame: Month 1 follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Difference in Proportion of Participants Likely to Vaccinate Between Study Arms at Month 1 | 1 Participants |
| Usual Care | Difference in Proportion of Participants Likely to Vaccinate Between Study Arms at Month 1 | 3 Participants |
Secondary
Difference in Proportion of Participants Likely to Vaccinate Between Study Arms at Month 2
Vaccine likelihood will be measured using a single question adapted from the CEAL Common Survey (i.e., On a scale from 1 to 7, with 1 being 'not at all likely' and 7 being 'very likely', how likely are you to get a COVID-19 vaccine in the next month?), with likely to vaccinate defined as a score of 5-7.
Time frame: Month 2 follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Difference in Proportion of Participants Likely to Vaccinate Between Study Arms at Month 2 | 4 Participants |
| Usual Care | Difference in Proportion of Participants Likely to Vaccinate Between Study Arms at Month 2 | 4 Participants |
Secondary
Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 1
Receipt of vaccination will be measured by self-report
Time frame: Month 1 follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 1 | 1 Participants |
| Usual Care | Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 1 | 2 Participants |
Secondary
Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 2
Receipt of vaccination will be measured by self-report
Time frame: Month 2 follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 2 | 1 Participants |
| Usual Care | Difference in Proportion of Participants Who Have Received >=1 Dose of Vaccine Between Study Arms at Month 2 | 2 Participants |