Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Human Immunodeficiency Virus | Study protocol

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)

Authors: David Goodman-Meza, Steven Shoptaw, Brett Hanscom, Laramie R. Smith, Philip Andrew, Irene Kuo, Jordan E. Lake, David Metzger, Ellen A. B. Morrison, Melissa Cummings, Jessica M. Fogel, Paul Richardson, Jayla Harris, Jesse Heitner, Sarah Stansfield, Nabila El-Bassel, for the HPTN 094 Study Team

Published in: Trials | Issue 1/2024

Login to get access

Abstract

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 and retained in MOUD and PrEP at 26 weeks post-randomization. Secondary outcomes measure the durability of intervention effects at 52 weeks following randomization.

Discussion

This 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 registration

ClinicalTrials.gov NCT04804072. Registered on 18 March 2021.
Appendix
Available only for authorised users
Literature
1.
2.
Kariisa MDN, Kumar S, et al. Vital signs: drug overdose deaths, by selected sociodemographic and social determinants of health characteristics—25 states and the District of Columbia, 2019–2020. MMWR Morb Mortal Wkly Rep. 2022;71:940–7.CrossRefPubMedPubMedCentral
3.
4.
Spetz J, Hailer L, Gay C, Tierney M, Schmidt L, Phoenix B, et al. Changes in US clinician waivers to prescribe buprenorphine management for opioid use disorder during the COVID-19 pandemic and after relaxation of training requirements. JAMA Netw Open. 2022;5(5):e225996.CrossRefPubMedPubMedCentral
5.
Amram O, Amiri S, Panwala V, Lutz R, Joudrey PJ, Socias E. The impact of relaxation of methadone take-home protocols on treatment outcomes in the COVID-19 era. Am J Drug Alcohol Abuse. 2021;47(6):722–9.CrossRefPubMed
6.
Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies—tackling the opioid-overdose epidemic. N Engl J Med. 2014;370(22):2063–6.CrossRefPubMed
7.
Volkow ND, Jones EB, Einstein EB, Wargo EM. Prevention and treatment of opioid misuse and addiction: a review prevention and treatment of opioid misuse and addiction prevention and treatment of opioid misuse and addiction. JAMA Psychiatry. 2019;76(2):208–16.CrossRefPubMed
8.
Mauro PM, Gutkind S, Annunziato EM, Samples H. Use of medication for opioid use disorder among US adolescents and adults with need for opioid treatment, 2019. JAMA Netw Open. 2022;5(3):e223821.CrossRefPubMedPubMedCentral
9.
Krawczyk N, Rivera BD, Jent V, Keyes KM, Jones CM, Cerdá M. Has the treatment gap for opioid use disorder narrowed in the U.S.?: a yearly assessment from 2010 to 2019. Int J Drug Policy. 2022;110:103786.CrossRefPubMed
10.
11.
National Academies of Sciences E, and Medicine. Opportunities to improve opioid use disorder and infectious disease services: integrating responses to a dual epidemic. Washington DC: The National Academies Press; 2020.
12.
Harvey L, Boudreau J, Sliwinski SK, Strymish J, Gifford AL, Hyde J, et al. Six moments of infection prevention in injection drug use: an educational toolkit for clinicians. Open Forum Infect Dis. 2022;9(2):ofab631.CrossRefPubMedPubMedCentral
13.
Handanagic S, Finlayson T, Burnett JC, Broz D, Wejnert C. HIV infection and HIV-associated behaviors among persons who inject drugs - 23 metropolitan statistical areas, United States, 2018. MMWR Morb Mortal Wkly Rep. 2021;70(42):1459–65.CrossRefPubMedPubMedCentral
14.
Rosenberg ES, Rosenthal EM, Hall EW, Barker L, Hofmeister MG, Sullivan PS, et al. Prevalence of hepatitis C virus infection in US states and the district of Columbia, 2013 to 2016. JAMA Netw Open. 2018;1(8):e186371.CrossRefPubMedPubMedCentral
15.
Platt L, Easterbrook P, Gower E, McDonald B, Sabin K, McGowan C, Yanny I, Razavi H, Vickerman P. Prevalence and burden of HCV co-infection in people living with HIV: a global systematic review and meta-analysis. Lancet Infect Dis. 2016;16(7):797–808.CrossRefPubMed
16.
Williams LD, Ibragimov U, Tempalski B, Stall R, Satcher Johnson A, Wang G, et al. Trends over time in HIV prevalence among people who inject drugs in 89 large US metropolitan statistical areas, 1992–2013. Ann Epidemiol. 2020;45:12–23.CrossRefPubMedPubMedCentral
17.
Des Jarlais DC, Sypsa V, Feelemyer J, Abagiu AO, Arendt V, Broz D, et al. HIV outbreaks among people who inject drugs in Europe, North America, and Israel. Lancet HIV. 2020;7(6):e434–42.CrossRefPubMed
18.
Strathdee SA, Kuo I, El-Bassel N, Hodder S, Smith LR, Springer SA. Preventing HIV outbreaks among people who inject drugs in the United States: plus ça change, plus ça même chose. AIDS. 2020;34(14):1997–2005.CrossRefPubMed
19.
Miller WC, Hoffman IF, Hanscom BS, Ha TV, Dumchev K, Djoerban Z, et al. A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study. Lancet. 2018;392(10149):747–59.CrossRefPubMedPubMedCentral
20.
Bartholomew TS, Andraka-Cristou B, Totaram RK, Harris S, Doblecki-Lewis S, Ostrer L, et al. “We want everything in a one-stop shop”: acceptability and feasibility of PrEP and buprenorphine implementation with mobile syringe services for Black people who inject drugs. Harm Reduct J. 2022;19(1):133.CrossRefPubMedPubMedCentral
21.
Peters PJ, Pontones P, Hoover KW, Patel MR, Galang RR, Shields J, et al. HIV infection linked to injection use of oxymorphone in Indiana, 2014–2015. N Engl J Med. 2016;375(3):229–39.CrossRefPubMed
22.
Golden MR, Lechtenberg R, Glick SN, Dombrowski J, Duchin J, Reuer JR, et al. Outbreak of human immunodeficiency virus infection among heterosexual persons who are living homeless and inject drugs - Seattle, Washington, 2018. MMWR Morb Mortal Wkly Rep. 2019;68(15):344–9.CrossRefPubMedPubMedCentral
23.
Cranston K, Alpren C, John B, Dawson E, Roosevelt K, Burrage A. Notes from the field: HIV diagnoses among persons who inject drugs - northeastern Massachusetts, 2015–2018. MMWR Morb Mortal Wkly Rep. 2019;68(10):253–4.CrossRefPubMedPubMedCentral
24.
Centers for Disease Control and Prevention (CDC). HIV surveillance report, 2014. 2015.
25.
(CDC) CfDCaP. HIV surveillance report, 2019. 2021. p. 32.
26.
27.
Streed CG Jr, Morgan JR, Gai MJ, Larochelle MR, Paasche-Orlow MK, Taylor JL. Prevalence of HIV preexposure prophylaxis prescribing among persons with commercial insurance and likely injection drug use. JAMA Netw Open. 2022;5(7):e2221346.CrossRefPubMedPubMedCentral
28.
El-Bassel N, Marotta PL, Gilbert L, Wu E, Springer S, Goddard-Eckrich D, et al. Integrating treatment for opioid use disorders and HIV services into primary care: solutions for the 21st century. In: Crosby RA, DiClemente RJ, (eds), Structural interventions for HIV prevention: optimizing strategies for reducing new infections and improving care. New York: Oxford Academic; 2018. https://​doi.​org/​10.​1093/​oso/​9780190675486.​003.​0008.
29.
Williams AR, Nunes EV, Bisaga A, Pincus HA, Johnson KA, Campbell AN, et al. Developing an opioid use disorder treatment cascade: a review of quality measures. J Subst Abuse Treat. 2018;91:57–68.CrossRefPubMedPubMedCentral
30.
Primm B. Overview of the Office for Treatment Improvement and its philosophy. J Psychoactive Drugs. 1991;23(2):113–4.CrossRefPubMed
31.
32.
Morgan JR, Schackman BR, Leff JA, Linas BP, Walley AY. Injectable naltrexone, oral naltrexone, and buprenorphine utilization and discontinuation among individuals treated for opioid use disorder in a United States commercially insured population. J Subst Abuse Treat. 2018;85:90–6.CrossRefPubMed
33.
34.
Forder A. Social work and system theory. Br J Soc Work. 1976;6(1):23–42.ADS
35.
Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am Psychol. 2000;55:68–78.CrossRefPubMed
36.
Perkins DD, Zimmerman MA. Empowerment theory, research, and application. Am J Community Psychol. 1995;23(5):569–79.CrossRefPubMed
37.
Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012;27(10):1361–7.CrossRefPubMedPubMedCentral
38.
Vaux A. Social support: theory, research, and intervention. Praeger Publishers; 1988. p. xiv, 346-xiv.
39.
Feldstein AC, Glasgow RE. A Practical, Robust Implementation and Sustainability Model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008;34(4):228–43.PubMed
40.
Miller CJ, Barnett ML, Baumann AA, Gutner CA, Wiltsey-Stirman S. The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare. Implement Sci. 2021;16(1):36.CrossRefPubMedPubMedCentral
41.
42.
43.
Iyengar S, Kravietz A, Bartholomew TS, Forrest D, Tookes HE. Baseline differences in characteristics and risk behaviors among people who inject drugs by syringe exchange program modality: an analysis of the Miami IDEA syringe exchange. Harm Reduct J. 2019;16(1):7.CrossRefPubMedPubMedCentral
44.
Allen ST, Ruiz MS, Jones J. Assessing syringe exchange program access among persons who inject drugs (PWID) in the district of Columbia. J Urban Health. 2016;93(1):131–40.CrossRefPubMedPubMedCentral
45.
Samji H, Cescon A, Hogg RS, Modur SP, Althoff KN, Buchacz K, et al. Closing the gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One. 2013;8(12):e81355.CrossRefPubMedPubMedCentralADS
46.
Antiretroviral Therapy Cohort Collaboration. Life expectancy of individuals on combination antiretroviral therapy in high-income countries: a collaborative analysis of 14 cohort studies. Lancet. 2008;372(9635):293–9.CrossRef
47.
Metzger DS, Woody GE, McLellan AT, O’Brien CP, Druley P, Navaline H, et al. Human immunodeficiency virus seroconversion among intravenous drug users in- and out-of-treatment: an 18-month prospective follow-up. J Acquir Immune Defic Syndr (1988). 1993;6(9):1049–56.PubMed
Metadata
Title
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)
Authors
David Goodman-Meza
Steven Shoptaw
Brett Hanscom
Laramie R. Smith
Philip Andrew
Irene Kuo
Jordan E. Lake
David Metzger
Ellen A. B. Morrison
Melissa Cummings
Jessica M. Fogel
Paul Richardson
Jayla Harris
Jesse Heitner
Sarah Stansfield
Nabila El-Bassel
for the HPTN 094 Study Team
Publication date
01-12-2024

Other articles of this Issue 1/2024

Trials 1/2024 Go to the issue

Study protocol

Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial

Study protocol

A randomised clinical trial study assessing the efficacy of 5% losartan potassium loaded in ethosomal gel to treat human keloids: a trial protocol

Study protocol

Anterior chamber proliferative membrane interception (AC-PMI)-enhanced trabeculectomy versus trabeculectomy for treating neovascular glaucoma: protocol for a randomized controlled trial

Study protocol

Personalizing the first dose of FSH for IVF/ICSI patients through machine learning: a non-inferiority study protocol for a multi-center randomized controlled trial

Study protocol

Increasing access to mental health supports for 12–17-year-old Indigenous youth with the JoyPop mobile mental health app: study protocol for a randomized controlled trial

Study protocol

Effect of maternal oxygen supplementation for parturient undergoing elective cesarean section by high-flow nasal oxygen compared with room air on fetal acidemia: study protocol for a randomized controlled trial