Mitigation of COVID-19 through onsite testing and education among formerly incarcerated individuals (the MOSAIC study): an open-label, single-centre, randomised controlled trial.

Publication date: Jul 01, 2026

Criminal legal system-involved individuals face barriers to care after release from carceral settings. Elevated SARS-CoV-2 risk while incarcerated, together with living in congregate settings post-incarceration, increase the risk of respiratory viral infection transmission. This study evaluated a community health worker-led point-of-care SARS-CoV-2 testing and education intervention in a re-entry-focused community-based organisation compared with standard referrals. This non-blinded, parallel group, randomised controlled trial, conducted in partnership with a community-based organisation in New York City (NYC), NY, USA, enrolled clients who were released from incarceration in the previous 90 days, fluent in English or Spanish, and residing within NYC for the study duration. Participants were randomly assigned (1:1) via computer-generated randomisation to onsite point-of-care testing and education or standard of care referral to offsite testing sites over 12 months. All participants were advised to test every 3 months. The study was not masked due to the nature of the intervention. The primary outcome was the proportion of patients with at least one SARS-CoV-2 test performed with results received during the 12-month period. Primary analyses were done by intention-to-treat using logistic or Poisson regression modelling. This trial was registered with ClinicalTrials. gov, NCT04878328, and is completed. Between April 14, 2022, and May 22, 2024, 572 formerly incarcerated individuals were assessed for study eligibility. After the exclusion of 247 individuals, and a further 75 who did not attend enrolment, 250 participants were randomly assigned to the two study groups (125 to onsite point-of-care testing and education and 125 to standard of care). 216 (86%) participants were cisgender men, 30 (12%) were cisgender women, two (1%) were transgender women, and two (1%) were non-binary; 120 (48%) were Black and 82 (33%) were Hispanic; mean age was 42.0 years (SD 11.8). 109 (87%) of the 125 participants in the onsite point-of-care testing and education group and 67 (54%) of 125 participants in the standard of care group had at least one complete SARS-CoV-2 test (odds ratio 5.9 [95% CI 3.1-11.1]; p

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