- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04801030
COVID-19 Vaccine Hesitancy Among African Americans
Using Multi-strategies to Address COVID-19 Vaccine Hesitancy Among African Americans
연구 개요
상세 설명
The goal of this application is to develop and test the feasibility and impact of a multi-layered, culturally-appropriate social marketing intervention targeting COVID-19 VH African Americans to increase uptake and completion of vaccine series in Nashville/Davidson County, Tennessee (TN). Investigators will partner with members of National Association for the Advancement of Colored People, Nashville Health Disparities Coalition, and Congregational Health Education Network to serve as an advisory committee. Investigators will also partner with Meharry Medical College (MMC) clinics and Tennessee Department of Health's (TDH) Immunization Program.
Aim 1. Engage with key stakeholders to develop a multi-layered, culturally-appropriate social marketing intervention targeting African Americans who are COVID-19 VH. Investigators will adapt an existing message library using the Health Belief Model,Theory of Reasoned Action, previous VH research, preliminary data of investigators, and feedback from community partners. Next, investigators will conduct semi-structured interviews with 25-30 VH individuals and 5-10 COVID-19 experts to elicit feedback on draft content. Qualitative data will be collected and analyzed iteratively, informing successive intervention modifications to cover a range of concerns for VH individuals, enhance message relevance, and determine media outlets for dissemination. Next, investigators will pre-test intervention prototypes with 16 COVID-19 VH individuals to make final modifications.
Aim 2a. Conduct a pilot study of the intervention and study protocol to demonstrate feasibility and assess impact. Investigators will conduct a pilot study using an experimental field trial design in three TN counties: Davidson County (1 intervention site) and Shelby and Hamilton Counties (2 control sites). COVID-19 vaccine uptake, primary outcome, assessed using: 1) aggregate data from partner clinics and TN immunization registry (TennIIS) and 2) individual, pre-post data from a marketing firm using random digit dialing (RDD). H1: COVID-19 vaccination rates will be higher for VH African Americans at intervention site compared to control sites. Implementation outcomes are feasibility, fidelity, acceptability, appropriateness, and penetration.
Aim 2b. To retrospectively explore knowledge, attitudes, intentions, and implementation outcomes post-intervention. Investigators will use qualitative methods to identify perceived acceptance of different types of media and webpage along with perceived change in knowledge, attitudes, and intentions from African Americans by degree of VH. Investigators will also explore appropriateness, feasibility, penetration, and fidelity as it relates to the social marketing intervention from 3 providers, 3 community-based organization (CBO) staff, and 2 TDH staff. Participants will be identified using RDD and community partner networks.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37208
- Meharry Medical College
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- African American
- Unvaccinated for COVID-19
- Vaccine hesitant
- 18 years and older
- Speaks English
Exclusion Criteria:
- Not African American
- Receipt of COVID-19 vaccination
- under 18 years of age
- Does not speak English
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Culturally-appropriate social marketing campaign
Participants will receive a multi-layered, social marketing campaign which is deemed culturally appropriate.
This will occur over a 6 month -time period.
Rates will be observed at 0, 6, and 12 months.
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The intervention will be delivered via multiple strategies- social media (YouTube, Facebook), radio, newspaper, tv ads, community partner networks.
Participants receive culturally-tailored message on COVID-19 and the vaccine.
The strategies will have a link that will open to a website that is optimized for viewing on a computer or mobile phone which has the look and feel of an app, but without requiring the user to download anything to the phone.
On the website, participants will be prompted to select their top concerns from a list.
Based on the responses, the top barriers or need will each be mapped to a corresponding educational message, which will be displayed to the user with appropriate images or graphics.
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간섭 없음: Control Arm 1
Participants will receive no intervention, only to serve as a control site.
Rates will be observed at 0, 6, and 12 months.
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간섭 없음: Control Arm 2
Participants will receive no intervention, only to serve as a control site.
Rates will be observed at 0, 6, and 12 months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment rates
기간: 6 months
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percent enrolled in study
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6 months
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Retention rates
기간: 1 year
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percent completed baseline survey, percent completed follow-up survey
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1 year
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data collection processes
기간: 1 year
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percent ascertained COVID 19 vaccine status post-intervention
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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COVID-19 vaccine rates
기간: 6 months
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Number of individuals vaccinated post-intervention
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6 months
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Attitudes toward COVID-19 vaccine
기간: 6 months
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Change in attitudes toward COVID-19 vaccine
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jennifer C Erves, PhD, Meharry Medical College
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 21-03-1076
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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