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评估 COVID-19 和 HIV 疫苗临床试验中的入组和代表性。

Evaluating enrollment and representation in COVID-19 and HIV vaccine clinical trials.

机构信息

Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, United States.

Harvard Medical School, Boston, MA, United States.

出版信息

Front Public Health. 2024 Jul 26;12:1411970. doi: 10.3389/fpubh.2024.1411970. eCollection 2024.


DOI:10.3389/fpubh.2024.1411970
PMID:39131572
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11311253/
Abstract

BACKGROUND: Vaccine clinical trials should strive to recruit a racially, socioeconomically, and ethnically diverse range of participants to ensure appropriate representation that matches population characteristics. Yet, full inclusion in research is often limited. METHODS: A single-center retrospective study was conducted of adults enrolled at Brigham and Women's Hospital (Boston, MA) between July 2020 and December 2021. Demographic characteristics, including age, race, ethnicity, ZIP code, and sex assigned at birth, were analyzed from both HIV and COVID-19 vaccine trials during the study period, acknowledging the limitations to representation under these parameters. We compared the educational attainment of vaccine trial participants to residents of the Massachusetts metropolitan area, geocoded participants' addresses to their census block group, and linked them to reported median household income levels from publicly available data for 2020. Frequency and quartile analyses were carried out, and spatial analyses were performed using ArcGIS Online web-based mapping software (Esri). RESULTS: A total of 1030 participants from four COVID-19 vaccine trials ( = 916 participants) and six HIV vaccine trials ( = 114 participants) were included in the analysis. The median age was 49 years (IQR 33-63) and 28 years (IQR 24-34) for the COVID-19 and HIV vaccine trials, respectively. Participants identifying as White were the majority group represented for both the COVID-19 ( = 598, 65.3%) and HIV vaccine trials ( = 83, 72.8%). Fewer than 25% of participants identified as Hispanic or Latin. Based on ZIP code of residence, the median household income for COVID-19 vaccine clinical trial participants ( = 846) was 102,088 USD (IQR = 81,442-126,094). For HIV vaccine clinical trial participants ( = 109), the median household income was 101,266 USD (IQR 75,052-108,832). CONCLUSION: We described the characteristics of participants enrolled for HIV and COVID-19 vaccine trials at a single center and found similitude in geographical distribution, median incomes, and proportion of underrepresented individuals between the two types of vaccine candidate trials. Further outreach efforts are needed to ensure the inclusion of individuals from lower educational and socioeconomic brackets. In addition, continued and sustained efforts are necessary to ensure inclusion of individuals from diverse racial and ethnic backgrounds.

摘要

背景:疫苗临床试验应努力招募各种不同种族、社会经济和族裔背景的参与者,以确保适当的代表性,与人口特征相匹配。然而,全面参与研究往往受到限制。

方法:对 2020 年 7 月至 2021 年 12 月期间在布莱根妇女医院(波士顿,马萨诸塞州)入组的成年人进行了一项单中心回顾性研究。分析了研究期间 HIV 和 COVID-19 疫苗试验中参与者的人口统计学特征,包括年龄、种族、族裔、ZIP 码和出生时分配的性别,并承认在这些参数下代表性存在限制。我们将疫苗试验参与者的教育程度与马萨诸塞州大都市区的居民进行了比较,将参与者的地址地理编码到他们的普查块组,并将其与 2020 年公开数据中报告的家庭中位数收入水平相关联。进行了频率和四分位分析,并使用 ArcGIS Online 网络地图软件(Esri)进行了空间分析。

结果:共纳入四项 COVID-19 疫苗试验( = 916 名参与者)和六项 HIV 疫苗试验( = 114 名参与者)的 1030 名参与者进行了分析。COVID-19 和 HIV 疫苗试验的中位年龄分别为 49 岁(IQR 33-63)和 28 岁(IQR 24-34)。COVID-19 疫苗试验( = 598,65.3%)和 HIV 疫苗试验( = 83,72.8%)中,大多数参与者为白人。不到 25%的参与者自认为是西班牙裔或拉丁裔。根据居住的邮政编码,COVID-19 疫苗临床试验参与者( = 846)的家庭中位数收入为 102088 美元(IQR = 81442-126094)。HIV 疫苗临床试验参与者( = 109)的家庭中位数收入为 101266 美元(IQR 75052-108832)。

结论:我们描述了在单一中心入组的 HIV 和 COVID-19 疫苗试验参与者的特征,发现两种候选疫苗试验在地理分布、中位数收入和代表性不足个体的比例方面存在相似性。需要进一步扩大外联努力,以确保包括来自教育和社会经济水平较低的个人。此外,还需要持续不断地努力,以确保包括来自不同种族和族裔背景的个人。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/554f3ac1fb0e/fpubh-12-1411970-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/89580354e130/fpubh-12-1411970-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/52abe9674bc7/fpubh-12-1411970-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/eda88099a362/fpubh-12-1411970-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/0b92a45843ea/fpubh-12-1411970-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/554f3ac1fb0e/fpubh-12-1411970-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/89580354e130/fpubh-12-1411970-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/52abe9674bc7/fpubh-12-1411970-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/eda88099a362/fpubh-12-1411970-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/0b92a45843ea/fpubh-12-1411970-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4454/11311253/554f3ac1fb0e/fpubh-12-1411970-g005.jpg

相似文献

[1]
Evaluating enrollment and representation in COVID-19 and HIV vaccine clinical trials.

Front Public Health. 2024

[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
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[10]
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本文引用的文献

[1]
Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials.

JAMA Netw Open. 2023-1-3

[2]
Leveraging lessons learned from the COVID-19 pandemic for HIV.

Commun Med (Lond). 2022-8-29

[3]
Race/ethnicity reporting and representation in US clinical trials: a cohort study.

Lancet Reg Health Am. 2022-7

[4]
Comparing the Efficiency of Online and Field-Based Outreach for the Recruitment of Black and Latino Sexual Minority Men into an HIV Prevention Implementation Trial.

Prev Sci. 2022-8

[5]
Digital approaches to enhancing community engagement in clinical trials.

NPJ Digit Med. 2022-3-25

[6]
Sex, gender and infectious disease.

Nat Microbiol. 2022-3

[7]
Racial and Ethnic Diversity in SARS-CoV-2 Vaccine Clinical Trials Conducted in the United States.

Vaccines (Basel). 2022-2-14

[8]
Improving Patient Race and Ethnicity Data Capture to Address Health Disparities: A Case Study From a Large Urban Health System.

Cureus. 2022-1-5

[9]
Why Calls to Diversify Trial Populations Fall Short.

Med. 2021-1-15

[10]
Comparing recruitment strategies to engage hard-to-reach men who have sex with men living with HIV with unsuppressed viral loads in four US cities: Results from HPTN 078.

J Int AIDS Soc. 2021-9

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