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Background: To address challenges with delivery of an evidencebased HIV care coordination program (CCP), the New York City Health Department initiated a CCP redesign. We conducted a siterandomized stepped-wedge trial to evaluate effectiveness of the revised versus the original model. Setting:The CCP is delivered in New York City hospitals, community health centers, and community-based organizations to people experiencing or at risk for poor HIV outcomes. Methods:The outcome, timely viral suppression (TVS), was defined as achievement of viral load ,200 copies/mL within 4 months among enrollees with unsuppressed viral load ($200 copies/mL). Seventeen original-CCP provider agencies were randomized within matched pairs to early (August 2018) or delayed (May 2019) starts of revised-model implementation. Data from 3 periods were examined to compare revised versus original CCP effects on TVS. The primary analysis of the intervention effect applied fully conditional maximum likelihood estimation together with an exact, conditional P-value and an exact test-based 95% CI. We assigned each trial enrollee the implementation level of their site (based on a three-component measure) and tested for association with TVS, adjusting for period and study arm.Results: Over 3 nine-month periods, 960 individuals were eligible for trial inclusion (intention to treat). The odds ratio of TVS versus no TVS comparing revised with original CCP was 0.88 (95% CI: 0.45, 1.7). Thus, the revised program yielded slightly lower TVS, although the effect was statistically nonsignificant. TVS was not significantly associated with revised-CCP implementation level. Conclusion:Program revisions did not increase TVS, irrespective of the implementation level.

IntroductionWith progress in the ‘diagnose’, ‘link’ and ‘retain’ stages of the HIV care continuum, viral suppression (VS) gains increasingly hinge on antiretroviral adherence among people with HIV (PWH) retained in care. The Centers for Disease Control and Prevention estimate that unsuppressed viral load among PWH in care accounts for 20% of onward transmission. HIV intervention strategies include ‘data to care’ (D2C)—using surveillance to identify out-of-care PWH for follow-up. However, most D2C efforts target care linkage, not antiretroviral adherence, and limit client-level data sharing to medical (versus support-service) providers. Drawing on lessons learnt in D2C and successful local pilots, we designed a ‘data-to-suppression’ intervention that offers HIV support-service programmes surveillance-based reports listing their virally unsuppressed clients and capacity-building assistance for quality-improvement activities. We aimed to scale and test the intervention in agencies delivering Ryan White HIV/AIDS Programme-funded behavioural health and housing services.Methods and analysisTo estimate intervention effects, this study applies a cross-sectional, stepped-wedge design to the intervention’s rollout to 27 agencies randomised within matched pairs to early or delayed implementation. Data from three 12-month periods (pre-implementation, partial implementation and full implementation) will be examined to assess intervention effects on timely VS (within 6 months of a report listing the client as needing follow-up for VS). Based on projected enrolment (n=1619) and a pre-implementation outcome probability of 0.40–0.45, the detectable effect size with 80% power is an OR of 2.12 (relative risk: 1.41–1.46).Ethics and disseminationThis study was approved by the New York City Department of Health and Mental Hygiene’s institutional review board (protocol: 21–036) with a waiver of informed consent. Findings will be disseminated via publications, conferences and meetings including provider-agency representatives.Trial registration numberNCT05140421.