Bien-Gund Cedric H, Stephens-Shields Alisa J, Acri Trisha, Dugosh Karen, Gross Robert
Division of Infectious Diseases, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia.
Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia.
JAMA Netw Open. 2025 Jun 2;8(6):e2513708. doi: 10.1001/jamanetworkopen.2025.13708.
Widespread and equitable access to testing remains critical to controlling the COVID-19 pandemic, which has disproportionately affected medically underserved communities.
To determine whether secondary distribution of COVID-19 self-test (ST) kits, in which an individual distributes ST kits to contacts in their social networks, increases COVID-19 testing.
DESIGN, SETTING, AND PARTICIPANTS: The COVID-19 Self-Testing Through Rapid Network Distribution study was a randomized clinical trial conducted between May 2021 and September 2023 at 4 federally qualified health centers serving medically underserved populations in Philadelphia, Pennsylvania. Participants were adults aged 18 years or older presenting to federally qualified health centers without SARS-CoV-2 infection in the past 90 days. Participants were randomized 1:1 to receive 5 COVID-19 ST kits or 5 clinic test referral cards to distribute to contacts in their social network, and testing among their social network contacts was measured. Investigators were masked to study group assignment. Data were analyzed from December 11, 2023, to August 23, 2024.
Participants in the intervention group received 5 COVID-19 ST kits; control participants received 5 clinic test referral cards.
The primary outcome was confirmed testing among at least 2 network contacts 8 weeks after randomization. Secondary outcomes included the proportion of participants with at least 1 network contact tested and total number of network contacts reached.
A total of 776 participants (median [IQR] age, 44 [32-57] years; 428 [55.2%] cisgender female) were included in the study, of whom 388 participants were randomized to the ST intervention group and 388 participants were randomized to the control group. There were 112 Hispanic or Latine participants (14.4%), 459 non-Hispanic Black participants (59.1%), and 120 non-Hispanic White participants (15.5%). There was no difference between study groups in the primary outcome, with 5 participants (1.3%) in the ST group vs 2 participants (0.5%) in the control group having at least 2 contacts confirmed tested at the 8-week follow-up (risk difference, 0.0077; 95% CI -0.0056 to 0.0210; P = .45).
This randomized clinical trial found that secondary distribution of COVID-19 ST kits had no effect on confirmed testing rates among network contacts, which were low in both study groups. Despite these null findings, the study provides insight that may be useful when designing and implementing ST trials.
ClinicalTrials.gov Identifier: NCT04797858.
广泛且公平地获得检测对于控制新冠疫情仍然至关重要，新冠疫情对医疗服务不足的社区造成了尤为严重的影响。
确定新冠病毒自我检测（ST）试剂盒的二次分发（即个人将ST试剂盒分发给其社交网络中的联系人）是否会增加新冠病毒检测。
设计、地点和参与者：“通过快速网络分发进行新冠病毒自我检测”研究是一项随机临床试验，于2021年5月至2023年9月在宾夕法尼亚州费城的4家为医疗服务不足人群服务的联邦合格健康中心进行。参与者为18岁及以上的成年人，在过去90天内未感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2），且前往联邦合格健康中心就诊。参与者按1:1随机分组，分别接受5个新冠病毒ST试剂盒或5张诊所检测转诊卡，以便分发给其社交网络中的联系人，并对其社交网络中的联系人的检测情况进行测量。研究人员对研究组分配情况不知情。数据于2023年12月11日至2024年8月23日进行分析。
干预组参与者接受5个新冠病毒ST试剂盒；对照组参与者接受5张诊所检测转诊卡。
主要结局是随机分组8周后至少2名网络联系人进行了确诊检测。次要结局包括至少有1名网络联系人接受检测的参与者比例以及接触到的网络联系人总数。
共有776名参与者（年龄中位数[四分位间距]为44[32 - 57]岁；428名[55.2%]为顺性别女性）纳入研究，其中388名参与者随机分配至ST干预组，388名参与者随机分配至对照组。有112名西班牙裔或拉丁裔参与者（14.4%）、459名非西班牙裔黑人参与者（59.1%）和120名非西班牙裔白人参与者（15.5%）。研究组在主要结局方面无差异，ST组有5名参与者（1.3%），对照组有2名参与者（0.5%）在8周随访时有至少2名联系人进行了确诊检测（风险差异为0.0077；95%置信区间为 - 0.0056至0.0210；P = 0.45）。
这项随机临床试验发现，新冠病毒ST试剂盒的二次分发对网络联系人中的确诊检测率没有影响，两个研究组的确诊检测率都很低。尽管有这些阴性结果，但该研究提供的见解可能对设计和实施ST试验有用。
ClinicalTrials.gov标识符：NCT04797858。
