DURHAM, N.C. – The HIV Prevention Trials Network (HPTN) announced today the launch of HPTN 094 (INTEGRA), a study to determine whether using mobile health units to deliver integrated health services for people with opioid use disorder (OUD) can improve HIV and substance use treatment and prevention. This study is being conducted by the HPTN and is sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) with funding from the U.S. National Institute on Drug Abuse (NIDA), both part of the U.S. National Institutes of Health (NIH). Study products for HIV treatment and prevention are provided by Gilead Sciences, Inc.
Drug overdose is the leading cause of accidental death in the United States, with more than 81,000 fatalities in the 12 months ending May 2020, the highest number of overdose deaths recorded in any 12-month period. The opioid overdose crisis remains one of the most widespread behavioral public health problems in the country. Factors such as lack of access to health care, poverty, mental health disorders, and use of multiple illicit substances combine to increase the risk of HIV transmission and acquisition and other health issues in people who inject drugs (PWID).
“People who inject drugs and are not taking medication for opioid use disorder, or MOUD, face the nearly impossible task of trying to get care with limited or no financial resources from brick-and-mortar clinics that provide separate, siloed services for opioid addiction, HIV, and primary care,” said Dr. Steven Shoptaw, INTEGRA protocol co-chair and director of the Center for Behavioral and Addiction Medicine at the University of California, Los Angeles. “Breaking down structural barriers to accessing health care is essential to improving outcomes.”
The HPTN 094 study will enroll approximately 860 people who inject drugs but are not receiving MOUD at five sites in Houston, Los Angeles, New York, Philadelphia, and Washington, D.C. The study aims to address the overlapping and intertwined public health crises of opioid addiction and HIV among PWID. The study will evaluate a strategy that brings integrated and judgement-free health services, supported by peer navigation, to locations PWID can easily access.
Health inequities remain and services needed to address the diverse needs of PWID are often far away from each other and from the PWID who need them, if they are available at all. This situation calls for an HIV prevention response that meets people where they are, with the aim to reduce barriers at each step in the process of accessing and sustaining MOUD treatment and HIV care and prevention.
“Meeting out-of-treatment PWID wherever they might be in their communities, providing them primary care services, and linking them to other needed care is likely to save lives,” said Dr. Wafaa El-Sadr, HPTN principal investigator, director of ICAP, and professor of epidemiology and medicine at Columbia University in New York.
Study participants are assigned at random to either the intervention arm or the active control arm. Intervention arm participants receive “one stop” health services in a mobile health unit and assistance from trained peers to access health care and stay in treatment (a program called peer health navigation) for 26 weeks. During this time, the mobile unit provides these participants with health care services including MOUD, antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) for HIV treatment and prevention, STI testing and treatment, harm reduction services, and screening and treatment referral for hepatitis, mental health issues, and other medical conditions. After 26 weeks, participants in this arm are referred to health services available in the community. Participants in the active control arm receive peer health navigation only, for 26 weeks, that connects them to services available at brick-and-mortar locations in the community. The study hopes to enroll at least 25 percent women and 25 percent participants under 30 years of age.
“Health risks for persons with OUD and at risk for or with HIV in the United States include multiple and overlapping problems that interfere with consistent access to health care, particularly when the substance use disorder is active,” said Dr. Nabila El-Bassel, INTEGRA protocol co-chair and University Professor at the Columbia University School of Social Work. “This makes this study such an important priority for this population.”
“The COVID-19 pandemic has changed the world in innumerable ways,” said Dr. Myron Cohen, HPTN principal investigator and director of the Institute for Global Health at the University of North Carolina at Chapel Hill. “These changes exacerbate challenges PWID already face. Strategies like mobile health clinics are already being used during the COVID-19 pandemic and have the potential to help PWID access needed health services.”
For more information about HPTN 094, visit www.hptn.org/research/studies/hptn094, or ClinicalTrials.gov using study identifier NCT04804072.
About the HPTN
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members, and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. The U.S. National Institute of Allergy and Infectious Diseases, the U.S. National Institute of Mental Health, Office of The Director, the U.S. National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all part of the U.S. National Institutes of Health, co-fund the HPTN. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations with a disproportionate HIV burden. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – is focused primarily on discovering new HIV prevention tools and evaluating integrated strategies, including biomedical interventions combined with behavioral risk reduction interventions and structural interventions. For more information, visit hptn.org.