The Cooperative Re-Engagement Controlled Trial (CoRECT): Durable Viral Suppression Assessment

Abstract

Background: A collaborative, data-to-care strategy to identify persons with HIV (PWH) newly out-of-care, combined with an active public health intervention, significantly increases the proportion of PWH re-engaged in HIV care. We assessed this strategy's impact on durable viral suppression (DVS).

Methods: A multisite, prospective randomized controlled trial for out-of-care individuals using a data-to-care strategy and comparing public health field services to locate, contact, and facilitate access to care versus the standard of care. DVS was defined as the last viral load, the viral load at least 3 months before, and any viral load between the 2 were all <200 copies/mL during the 18-month postrandomization. Alternative definitions of DVS were also analyzed.

Results: Between August 1, 2016-July 31, 2018, 1893 participants were randomized from Connecticut (n = 654), Massachusetts (n = 630), and Philadelphia (n = 609). Rates of achieving DVS were similar in the intervention and standard-of-care arms in all jurisdictions (all sites: 43.4% vs 42.4%, P = 0.67; Connecticut: 46.7% vs 45.0%, P = 0.67; Massachusetts: 40.7 vs 44.4%, P = 0.35; Philadelphia: 42.4% vs 37.3%, P = 0.20). There was no association between DVS and the intervention (RR: 1.01, CI: 0.91-1.12; P = 0.85) adjusting for site, age categories, race/ethnicity, birth sex, CD4 categories, and exposure categories.

Conclusion: A collaborative, data-to-care strategy, and active public health intervention did not increase the proportion of PWH achieving DVS, suggesting additional support to promote retention in care and antiretroviral adherence may be needed. Initial linkage and engagement services, through data-to-care or other means, are likely necessary but insufficient for achieving DVS for all PWH.

Trial registration: ClinicalTrials.gov NCT02693145.

FIGURE 1.

Percentage of adults with HIV participating in CoRECT achieving durable viral suppression* by study arm and location, year 2016–2019 (N = 1893). * Durable viral suppression was defined as fulfilling 3 criteria: (1) the last viral load recorded in the 18-month follow-up period after randomization is less than 200 copies/mL; (2) and the viral load immediately before, but at least 3 months apart from, the last recorded viral load is less than 200 copies/mL;and (3) all viral load results between times 1 and 2 are less than 200 copies/mL.