Mobile HIV and Addiction Care for People Who Inject Drugs Reduces All-Cause Deaths by 71% in Five U.S. Cities (HPTN 094)

Researchers from the HIV Prevention Trials Network (HPTN) published new findings from the HPTN 094 (INTEGRA) trial showing that while an integrated strategy of mobile co-delivery of HIV pre-exposure prophylaxis (PrEP) and medication for opioid use disorder (MOUD) did not significantly increase the use of either intervention services at 26 weeks compared to a standard-of-care comparison group, it did show a 71% reduction in all-cause deaths at 52-week follow-up visits.

The one-year study enrolled 409 adults without HIV who injected drugs, had opioid use disorder, were not taking MOUD at enrollment, and were willing to consider MOUD. The intervention group received 26 weeks of peer navigation plus integrated PrEP, MOUD, and limited clinical and supportive services delivered on a mobile unit. The active comparison group received 26 weeks of peer navigation services that linked participants to available community services. Four deaths were observed in the intervention group. 13 deaths were observed in the comparison group. Researchers recruited participants in Houston, Texas; Los Angeles, California; New York City, New York; Philadelphia, Pennsylvania; and Washington, D.C., USA.

"Our findings show that bringing integrated care for HIV prevention and opioid use disorder to people who inject drugs who live in our cities and who are out of treatment helps many to start and to remain in care after six months," said Dr. Steven Shoptaw, HPTN 094 protocol co-chair and professor in the University of California at Los Angeles (UCLA) departments of Family Medicine, Psychiatry, and Biobehavioral Sciences. "When that integrated care is delivered using peer navigation on mobile units, there is a suggestion that all-cause mortality is reduced one year later compared to peer navigation alone to available community services."

HPTN 094 (INTEGRA) is the only randomized controlled trial to test the efficacy of using mobile integrated health services for opioid use disorder and HIV prevention or treatment for people who inject drugs. By design, this study tested outcomes of delivering whole-person, integrated strategies using mobile medical units with peer navigation to local services, compared with peer navigation to local services alone.

"People who inject drugs often face fragmented care systems, unstable housing, stigma, and other barriers that make sustained care difficult," said HPTN 094 protocol co-chair and professor at Columbia University, Dr. Nabila El-Bassel. "This shows why we must continue developing low-threshold models that meet people where they are and connect HIV prevention, addiction treatment, and supportive care in ways that are accessible and responsive to their lives."

Findings that highlight the difficulty of sustaining PrEP and MOUD use among many people who inject drugs, even when peer navigation and integrated services are made available, provide a key starting point for future studies to improve long-term outcomes. They also support further research on mobile, low-threshold service models, patterns of entering and leaving MOUD treatment, and long-acting HIV-prevention options for people who inject drugs.

"The HPTN has a strong commitment to improving the health of people who inject drugs using medications to prevent HIV and to promote life-saving treatments for addiction," said Dr. Raphael Landovitz, HPTN co-principal investigator and chief of the Division of Infectious Diseases at the David Geffen School of Medicine at UCLA. "This study suggests that future research to prevent HIV transmission and to support addiction recovery will likely center on using new long-acting formulations of medications for both these health goals among people who inject drugs."

The HPTN develops, implements, and evaluates research that combines novel and existing HIV prevention strategies with other products or methods that address several health needs at once, making it more likely to reach people, sustain use over time, and achieve greater health outcomes.

"Findings from this work show that people who inject drugs can have life-saving benefits when interventions are designed to bring them closer to medical and social services," said Dr. Sinead Delany-Moretlwe, HPTN co-principal investigator and Professor of Global Health and Infectious Diseases at the University of the Witwatersrand in Johannesburg, South Africa. "These findings are in agreement with those from a previous HPTN study conducted in other countries that showed people living with HIV who inject drugs had fewer deaths when provided with low-barrier access to medications for HIV and for addiction compared to treatment as usual."

Research reported in this press release was supported by the U.S. National Institute of Allergy and Infectious Diseases and the U.S. National Institute on Drug Abuse under award numbers UM1AI068619, UM1AI068617, and UM1AI068613. The content is solely the authors' responsibility and does not necessarily represent the official views of the National Institutes of Health.

About the Study

HPTN 094 (INTEGRA) evaluated whether a mobile health unit could effectively deliver integrated, judgment-free care, including medication for opioid use disorder (OUD) and HIV treatment or prevention, to people with OUD who inject drugs in five U.S. cities. The study enrolled adults ages 18 to 60 with OUD who injected drugs, were living with or at risk for HIV, and were willing to begin OUD treatment. Learn more about the study by visiting ClinicalTrials.gov under trial number 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. Overall support for the HPTN is provided by the National Institute of Allergy and Infectious Diseases (NIAID), Office of the Director (OD), National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).