Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study)

作者：David Goodman‐Meza, Steven Shoptaw, Brett Hanscom, Laramie R. Smith, P. Andrew, Irene Kuo, Jordan E. Lake, David S. Metzger, Ellen A. B. Morrison, Melissa Cummings, Jessica M. Fogel, Paul Richardson, Jayla Harris, Jesse Heitner, Sarah E. Stansfield, Nabila El‐Bassel, for the HPTN 094 Study Team · 发表于：Trials · 年份：2024 · DOI：10.1186/s13063-023-07899-5 · 被引用次数：14 · 研究领域：HIV, Drug Use, Sexual Risk、HIV/AIDS Research and Interventions、Opioid Use Disorder Treatment

BACKGROUND: Persons with opioid use disorders who inject drugs (PWID) in the United States (US) face multiple and intertwining health risks. These include interference with consistent access, linkage, and retention to health care including medication for opioid use disorder (MOUD), HIV prevention using pre-exposure prophylaxis (PrEP), and testing and treatment for sexually transmitted infections (STIs). Most services, when available, including those that address substance misuse, HIV prevention, and STIs, are often provided in multiple locations that may be difficult to access, which further challenges sustained health for PWID. HPTN 094 (INTEGRA) is a study designed to test the efficacy of an integrated, "whole-person" strategy that provides integrated HIV prevention including antiretroviral therapy (ART), PrEP, MOUD, and STI testing and treatment from a mobile health delivery unit ("mobile unit") with peer navigation compared to peer navigation alone to access these services at brick and mortar locations. METHODS: HPTN 094 (INTEGRA) is a two-arm, randomized controlled trial in 5 US cities where approximately 400 PWID without HIV are assigned either to an experimental condition that delivers 26 weeks of "one-stop" integrated health services combined with peer navigation and delivered in a mobile unit or to an active control condition using peer navigation only for 26 weeks to the same set of services delivered in community settings. The primary outcomes include being alive a...