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| ID | Type | Description | Link |
|---|---|---|---|
| OT2 HL158260 | Other Grant/Funding Number | NIH |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community health worker engagement | Behavioral | 3-4 in-person or virtual engagements (individual or group sessions) over 1 month, each engagement lasting 30 minutes to 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 1 follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Krousel-Wood, MD, MSPH | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Usual Care | No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 | 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. | Posted | Count of Participants | Participants | Month 1 follow-up |
|
2 months
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Peacock | Tulane University | 504-988-1075 | epeacoc@tulane.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, 2023 | Dec 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000072758 | Vaccination Refusal |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Month 2 follow-up |
| 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 | Month 1 follow-up |
| 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 | Month 2 follow-up |
No intervention
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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. | Posted | Count of Participants | Participants | Month 2 follow-up |
|
|
|
| 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 | Posted | Count of Participants | Participants | Month 1 follow-up |
|
|
|
| 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 | Posted | Count of Participants | Participants | Month 2 follow-up |
|
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Usual Care | No intervention | 0 | 29 | 0 | 29 | 0 | 29 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |