跳至主要内容
临床试验/NCT05541393
NCT05541393撤回不适用

Engaging Church Health Ministries to Decrease COVID-19 (COVID-19) Vaccine Hesitancy in Underserved Populations in Baton Rouge

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家开始时间: 2023年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in COVID-19 Vaccine/Booster Hesitancy from Baseline to 3 Weeks

研究概览

简要总结

This study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities.

详细描述

This study will determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines and booster shots for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities. A total of 98 participants from three-to-five churches will be randomized to an intervention group that will receive counseling from their health ministers on the benefits of getting vaccinated, boosted, and tested, or to a delayed intervention control group. The effects of the intervention on the primary outcome, change in vaccine/booster hesitancy, will be assessed by a questionnaire that will be administered to both groups at baseline and after three weeks. Following the three-week control period, the delayed intervention control group will also receive the intervention and again be administered the questionnaire. Questionnaires will be used to obtain more granular information on sources of vaccine/booster hesitancy and for their vaccine-related decisions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age ≥ 18 y
  • •Not having received an initial COVID-19 vaccine or a booster vaccine at the recommended interval
  • •Having vaccine or booster hesitancy
  • •Able to understand and speak English
  • •Willing to engage with the church's health ministry via in-person or virtual/phone sessions

排除标准

  • 未提供

研究组 & 干预措施

Delayed Control Group

No Intervention

Participants in the delayed intervention control group will not receive any outreach during the three-week control period. Subsequent to completing the follow-up questionnaire, they will then be invited to join the intervention for the next three weeks. A follow-up questionnaire will be administered following their intervention period to be used in later analyses.

COVID-19 Education Group

Experimental

Participants randomized to the intervention will be engaged over a three-week period in discussions by their health ministries; any identified concerns or barriers around the initial vaccination series and/or booster vaccinations will be addressed and the importance of continued COVID-19 testing will be emphasized. Evidence-based vaccine strategies that focus on positive framing will be employed

干预措施: Active Intervention Group (Behavioral)

结局指标

主要结局

Change in COVID-19 Vaccine/Booster Hesitancy from Baseline to 3 Weeks

时间窗: Baseline and three weeks

Vaccine hesitancy will be measured in those who indicate that they have not received the initial vaccine in a single or 2-series protocol using a single question: "How likely are you to get an approved COVID-19 vaccine?" Responses are recorded on a 7-point scale, with 1 being "not at all likely" and 7 being "very likely". Vaccine hesitancy will be defined as a score of 1 to 4 on the scale. Among individuals who have received the initial vaccine series, but not the booster, booster hesitancy will be measured using the following question: "How likely are you to get an approved COVID-19 booster shot?" Responses are recorded on a 7-point scale, with 1 being "not at all likely" and 7 being "very likely". Booster hesitancy will be defined as a score of 1 to 4 on the scale.

次要结局

  • Change in Vaccine/Booster Uptake from Baseline to 3 Weeks(Baseline and three weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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