Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Apr 1;92(4):325-333.
doi: 10.1097/QAI.0000000000003139. Epub 2022 Dec 22.

Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial

Mary K Irvine  1 , Bruce Levin  2 , Faisal Abdelqader  1 , Jennifer Carmona  1 , Tigran Avoundjian  1 , Jacinthe Thomas  1 , Sarah L Braunstein  1 , McKaylee Robertson  3 , Denis Nash  3
Affiliations
Randomized Controlled Trial

Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial

Mary K Irvine et al. J Acquir Immune Defic Syndr. .

Abstract

Background: To address challenges with delivery of an evidence-based HIV care coordination program (CCP), the New York City Health Department initiated a CCP redesign. We conducted a site-randomized 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.

Trial registration: ClinicalTrials.gov NCT03628287.

PubMed Disclaimer

Figures

FIGURE 1.
FIGURE 1.
Stepped-wedge design with 3 implementation periods (2 transitions to revised intervention).
FIGURE 2.
FIGURE 2.
Hypothesized pathways from intervention features to outcome: TVS.
FIGURE 3.
FIGURE 3.
Client-level flow diagram.
See this image and copyright information in PMC

References

    1. The INSIGHT START Study Group, Lundgren JD, Babiker AG, Gordin F, et al. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373:795–807. - PMC - PubMed
    1. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365:493–505. - PMC - PubMed
    1. The TEMPRANO ANRS 12136 Study Group. A trial of early antiretrovirals and isoniazid preventive therapy in Africa. New Engl J Med. 2015;373:808–822. - PubMed
    1. Dombrowski JC, Ramchandani M, Dhanireddy S, et al. The Max Clinic: medical care designed to engage the hardest-to-reach persons living with HIV in Seattle and King County, Washington. AIDS Patient Care and STDs. 2018;32:149–156. - PMC - PubMed
    1. Dombrowski JC, Galagan SR, Ramchandani M, et al. HIV care for patients with complex needs: a controlled evaluation of a walk-in, incentivized care model. Open Forum Infect Dis. 2019;6:ofz294. - PMC - PubMed

Publication types

Associated data