Secondary Distribution of COVID-19 Self-tests vs. Referrals to Increase Test Uptake in Underserved Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 792
- 试验地点
- 2
- 主要终点
- Network Contact Test Uptake
研究概览
简要总结
COVID-19, the coronavirus disease caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has led to a global pandemic and has exacerbated existing health inequities among vulnerable populations. Despite higher rates of COVID-19 in Black and Latinx individuals compared to White individuals, rates of testing in predominately non-White, low-income communities are significantly lower than in high-income areas. Self-testing, where individuals collect their own samples, is now feasible for the detection of SARS-CoV-2. One promising approach to increase test uptake is the secondary distribution of self-testing kits, where an individual distributes tests to contacts in their social network and encourages them to self-test.
The central hypothesis of this clinical trial is that the secondary distribution of SARS-CoV-2 self-tests can significantly expand test uptake among underserved populations. To test this hypothesis, the investigators will conduct a 1:1 randomized controlled trial that will assess a self-testing intervention that promotes the secondary distribution of SARS-CoV-2 test kits compared with test referrals, with a focus on reaching underserved populations.
详细描述
Strategies to rapidly disseminate COVID-19 testing are urgently needed, particularly to address increasing health disparities among underserved communities. One promising approach to increase test uptake is the secondary distribution of self-tests, where an individual distributes test kits to contacts in their social network and encourages them to self-test. By decentralizing testing, this approach does not require individuals to have contact with medical systems, and can lower potential barriers to obtaining testing. This approach can increase case detection by facilitating testing among exposed individuals, and potentially ameliorate stigma, fear, and medical mistrust associated with COVID-19 among vulnerable populations because the testing process is decentralized.
The investigators will conduct a 1:1 randomized controlled trial randomizing individuals to receive either multiple self-test kits to distribute within their social circles, or referrals for standard clinic-based tests. All study participants will be offered testing upon enrollment. Study participants, deemed "Index Participants," will be randomized to receive multiple self-testing kits (intervention) or test referral cards and text messages (control) to encourage individuals in their social networks, deemed "network contacts" to test. Participants will complete a baseline evaluation and a follow-up evaluation at 8 weeks. We will measure network contact test uptake in both study arms. The central hypothesis of this trial is that distribution of self-test kits will increase test uptake compared with distribution of test referrals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •18 years of age or older
- •Has a working telephone number
- •Willing and able to provide informed consent
排除标准
- •Younger than 18 years of age
- •Does not have a working telephone number
- •Prior COVID-19 infection in the past 90 days
- •Previously received a COVID-19 test as part of this COVID-19 research study
- •Unable or unwilling to provide informed consent
结局指标
主要结局
Network Contact Test Uptake
时间窗: 8 weeks
The primary outcome is the proportion of study participants who distributed tests/referrals to least two network contacts who completed testing. This outcome will be measured by number of participants with at least 2 unique network contacts who completed a test linked to a study participant by week 8. The investigators will test for differences in the primary outcome between the two study arms.
次要结局
- Number of Contacts Tested at 8 Weeks(8 weeks)
- Number of Contacts Tested(Through study completion, up to 30 months)
- Network Contact Test Uptake, End of Study(Through study completion, up to 30 months.)
- Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19 at 8 Weeks(8 weeks)
- Number of Participants With at Least One Network Contact Who Tested Positive for COVID-19, End of Study(Through study completion, up to 30 months)
研究者
Robert Gross
Professor of Medicine
University of Pennsylvania
