数据抑制（D2S）研究方案：一项针对纽约市住房和行为健康项目中提高 HIV 病毒抑制率的报告和能力建设干预措施的集群随机、阶梯式有效性试验。

Study protocol for data to suppression (D2S): a cluster-randomised, stepped-wedge effectiveness trial of a reporting and capacity-building intervention to improve HIV viral suppression in housing and behavioural health programmes in New York City.

机构信息

Bureau of Hepatitis, HIV, and Sexually Transmitted Infections, New York City Department of Health and Mental Hygiene, New York City, New York, USA

Bureau of Hepatitis, HIV, and Sexually Transmitted Infections, New York City Department of Health and Mental Hygiene, New York City, New York, USA.

出版信息

BMJ Open. 2023 Jul 14;13(7):e076716. doi: 10.1136/bmjopen-2023-076716.

DOI:10.1136/bmjopen-2023-076716

PMID:37451738

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10351323/

Abstract

INTRODUCTION

With 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 ANALYSIS

To 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 DISSEMINATION

This 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 NUMBER

NCT05140421.

摘要

简介

随着 HIV 护理连续体的“诊断”、“关联”和“保留”阶段取得进展，病毒抑制（VS）越来越取决于接受 HIV 护理的患者（PWH）的抗逆转录病毒依从性。疾病控制和预防中心估计，接受护理的 PWH 中未抑制的病毒载量占传播的 20%。HIV 干预策略包括“数据到护理”（D2C）-利用监测来识别护理中脱离的 PWH 进行随访。然而，大多数 D2C 工作都针对护理关联，而不是抗逆转录病毒依从性，并且将客户层面的数据共享限制在医疗（而非支持服务）提供者。借鉴 D2C 和成功的本地试点经验，我们设计了一种“数据到抑制”干预措施，为 HIV 支持服务计划提供基于监测的报告，列出其病毒未抑制的客户，并为质量改进活动提供能力建设援助。我们旨在扩大规模并在提供 Ryan White HIV/AIDS 计划资助的行为健康和住房服务的机构中测试该干预措施。

方法和分析

为了估计干预效果，本研究对该干预措施在 27 个随机分配到匹配对的机构中的推出应用了横断面、逐步楔形设计。将检查三个 12 个月期间（实施前、部分实施和全面实施）的数据，以评估干预措施对及时 VS（在报告列出需要随访以进行 VS 的客户后 6 个月内）的影响。根据预计的入组人数（n=1619）和实施前结果概率为 0.40-0.45，80%效力下可检测到的效应大小为 OR 为 2.12（相对风险：1.41-1.46）。