Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:92 |
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| Enthalten in: |
Journal of acquired immune deficiency syndromes (1999) - 92(2023), 4 vom: 01. Apr., Seite 325-333 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Irvine, Mary K [VerfasserIn] |
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| Links: |
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| Themen: |
Journal Article |
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| Anmerkungen: |
Date Completed 05.03.2023 Date Revised 21.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT03628287 Citation Status MEDLINE |
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| doi: |
10.1097/QAI.0000000000003139 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Irvine, Mary K |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03628287 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSION: Program revisions did not increase TVS, irrespective of the implementation level | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 700 | 1 | |a Levin, Bruce |e verfasserin |4 aut | |
| 700 | 1 | |a Abdelqader, Faisal |e verfasserin |4 aut | |
| 700 | 1 | |a Carmona, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Avoundjian, Tigran |e verfasserin |4 aut | |
| 700 | 1 | |a Thomas, Jacinthe |e verfasserin |4 aut | |
| 700 | 1 | |a Braunstein, Sarah L |e verfasserin |4 aut | |
| 700 | 1 | |a Robertson, McKaylee |e verfasserin |4 aut | |
| 700 | 1 | |a Nash, Denis |e verfasserin |4 aut | |
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