Provision of COVID-19 Self-Test Kits to Patients for Distribution to Social Contacts: A Randomized Clinical Trial.

IMPORTANCE

Widespread and equitable access to testing remains critical to controlling the COVID-19 pandemic, which has disproportionately affected medically underserved communities.

OBJECTIVE

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.

INTERVENTION

Participants in the intervention group received 5 COVID-19 ST kits; control participants received 5 clinic test referral cards.

MAIN OUTCOMES AND MEASURES

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.

RESULTS

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).

CONCLUSIONS AND RELEVANCE

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.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04797858.