1. 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)
- Author
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Goodman-Meza, David, Shoptaw, Steven, Hanscom, Brett, Smith, Laramie R, Andrew, Philip, Kuo, Irene, Lake, Jordan E, Metzger, David, Morrison, Ellen AB, Cummings, Melissa, Fogel, Jessica M, Richardson, Paul, Harris, Jayla, Heitner, Jesse, Stansfield, Sarah, and El-Bassel, Nabila
- Subjects
Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Clinical Sciences ,Social Determinants of Health ,Brain Disorders ,Minority Health ,Sexually Transmitted Infections ,Health Disparities ,Comparative Effectiveness Research ,Behavioral and Social Science ,Infectious Diseases ,Clinical Trials and Supportive Activities ,Opioid Misuse and Addiction ,Substance Misuse ,Clinical Research ,Prevention ,Women's Health ,HIV/AIDS ,Health Services ,Drug Abuse (NIDA only) ,Opioids ,6.6 Psychological and behavioural ,8.1 Organisation and delivery of services ,Infection ,Mental health ,Good Health and Well Being ,Humans ,Pharmaceutical Preparations ,Substance Abuse ,Intravenous ,Drug Users ,HIV Infections ,Sexually Transmitted Diseases ,Opioid-Related Disorders ,Randomized Controlled Trials as Topic ,HPTN 094 Study Team ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,General & Internal Medicine ,Clinical sciences ,Epidemiology ,Health services and systems - Abstract
BackgroundPersons 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.MethodsHPTN 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 and retained in MOUD and PrEP at 26 weeks post-randomization. Secondary outcomes measure the durability of intervention effects at 52 weeks following randomization.DiscussionThis trial responds to a need for evidence on using a "whole-person" strategy for delivering integrated HIV prevention and substance use treatment, while testing the use of a mobile unit that meets out-of-treatment PWID wherever they might be and links them to care systems and/or harm reduction services. Findings will be important in guiding policy for engaging PWID in HIV prevention or care, substance use treatment, and STI testing and treatment by addressing the intertwined epidemics of addiction and HIV among those who have many physical and geographic barriers to access care.Trial registrationClinicalTrials.gov NCT04804072 . Registered on 18 March 2021.
- Published
- 2024