A clinical trial is underway in five US cities to determine whether the delivery of integrated health services through mobile clinics can improve HIV and substance abuse outcomes in people with opioid use disorders who inject drugs. If effective, mobile clinics could serve as an innovative strategy to expand access to care and provide uninterrupted treatment to this underserved population that is tackling public health crises related to drug addiction and HIV.
According to the Centers for Disease Control and Prevention, about 1 in 10 new HIV diagnoses in the United States are attributed, in whole or in part, to injection drug use. Additionally, high rates of injection drug use in communities have been linked to HIV outbreaks. Although injection drug use is not limited to injecting opioids – a class of drugs that includes heroin and fentanyl – these drugs have a high rate of use among key populations in this new study . Almost all study participants are expected to inject opioids at the time of enrollment. Substance use and dependence can also have a disruptive effect in a person’s life that may make it difficult to take daily medications, including antiretroviral therapy (ART) for the treatment of HIV or pre-exposure prophylaxis ( PrEP) for HIV prevention.
The study aims to address these challenges by providing holistic health services delivered in accessible mobile clinics. These integrated services include safe and effective medications for opioid use disorders (buprenorphine) and overdose reversal (naloxone or Narcan), syringe services where available, HIV testing. , antiretroviral therapy for treatment of HIV, PrEP for prevention of HIV, tests for hepatitis and sexually transmitted infections. (STI) and primary care services. Mobile clinics will be set up in residential areas deemed accessible to people living with HIV who inject opioids. In contrast, many community organizations are located throughout downtown and shopping areas which can be difficult to access for people with limited transportation options.
Too often, drug treatment and life-saving HIV care are delivered by a patchwork of health professionals under many different roofs, presenting major access challenges for people who use opioids and drugs. other drugs. By providing these services through a welcoming one-stop-shop and meeting people where they are, we hope to find a way to more effectively treat people with HIV and substance use disorders. “
Nora D. Volkow, MD, Director of NIDA
The study, known as INTEGRA or HPTN 094, is funded by the National Institute on Drug Abuse (NIDA) and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), both of which are part of the National Institutes of Health. INTEGRA is led by the NIH-funded HIV Prevention Trials Network (HPTN) at locations in Los Angeles, New York, Houston, Philadelphia and Washington, DC
“People are more than their HIV status or their diagnosis of addiction, but these factors make it difficult to access care,” Steven Shoptaw, Ph.D., president of the INTEGRA protocol and director of the Center for Behavioral and Addiction Medicine, told the University of California, Los Angeles. “The COVID-19 pandemic has restricted access to medical care for so many people. At the same time, the intertwined epidemics of opioid addiction and HIV continued to take their toll. Now is the time to test innovative strategies to connect our most vulnerable populations. effective and integrated care.
Nabila El-Basel, Ph.D., university professor at Columbia University School of Social Work, is co-chair of the INTEGRA protocol.
The study team aims to recruit 860 participants with opioid use disorders who inject drugs. Equal numbers of participants will be randomly assigned to receive care through a single mobile clinic or multiple community agencies. The latter group, which reflects the current standard of care, will serve as the control arm of the study.
For 26 weeks, participants in both parts of the study will have access to trained peer navigators to help coordinate and facilitate care visits, during which they will be offered routine health services based on identified needs. during the initial assessment. At weeks 26 and 52, researchers will assess drug use for opioid use disorders, viral suppression rates in HIV-positive participants, use of PrEP in HIV-negative participants, use of opioids and other substances based on participant self-report and urine. screenings, drug overdose events and new diagnoses of HIV, SARS-CoV-2 (the virus that causes COVID-19), hepatitis C and bacterial STIs, among other health measures in both groups.
Investigators will also analyze the cost-effectiveness and logistical value of providing care through mobile clinics versus community agencies. INTEGRA’s results are expected in 2025.
Learn more about HPTN 094 / INTEGRA, or “A Vanguard Study of Health Service Delivery in a Mobile Health Delivery Unit to Link Persons who Inject Drugs to Integrated Care and Prevention for Addiction, HIV, HCV and Primary Care” by visiting ClinicalTrials.gov and using study ID NCT04804072 and HPTN.org.