The four-year study is funded by the National Institute on Drug Abuse and sponsored by the National Institute of Allergy and Infectious Diseases.
By Thomas Kohout
A team of researchers from the George Washington University (GW) has been selected as one of five groups that will participate in the HIV Prevention Trials Network (HPTN) INTEGRA study (HTPN 094), which will determine whether using mobile health units to deliver integrated health services can improve HIV and substance use outcomes among people with opioid use disorder who inject drugs.
The study is sponsored by the National Institute of Allergy and Infectious Diseases with funding from the National Institute on Drug Abuse, both part of the National Institutes of Health
Leading the GW research team is principal investigator Irene Kuo, associate research professor of epidemiology in the Milken Institute School of Public Health, and co-investigator Marc Siegel, associate professor of medicine at the School of Medicine and Health Sciences and leader of the NIH-funded GW HPTN Clinical Research Site
“The study focuses on offering integrated care for substance use, HIV care or prevention and treatment for sexually transmitted infections, as well as referrals for care of viral hepatitis, especially hepatitis C,” Dr. Kuo said. At the end of a 26-week period, Dr. Kuo added, researchers hope to see increased uptake of substance abuse treatment and medication for HIV prevention and care among study volunteers.
Overall, the INTEGRA study will enroll approximately 860 volunteers, between the ages of 18 and 60, in Houston; Philadelphia; the Bronx, New York; Los Angeles; and Washington, D.C. The volunteers must be people who inject drugs and do not currently receive medical treatment for opioid use disorder.
Irene Kuo (l) associate research professor of epidemiology in the Milken Institute School of Public Health, and Marc Siegel, associate professor of medicine at the School of Medicine and Health Sciences.
The GW team is looking to enroll a 172-person cohort from several locations in the city. Study participants will be randomly assigned to either the intervention group or an active control group. Intervention participants will receive integrated health services from the mobile health unit that includes HIV and hepatitis testing, prevention and treatment services, as well as assistance from trained peer navigators to access health care and stay in treatment for opioid use. Those in the control group will be assigned to a peer navigator who will refer the participant to established services in the community.
“The hypothesis is that people with opioid use disorder have many barriers to care,” said Dr. Siegel. People who inject drugs, he added, “tend to have other underlying medical conditions—HIV, sexually transmitted infections, diabetes, hypertension, mental health disorders—so when they get into an opioid treatment program, those other health care needs aren’t addressed.”
“By bringing care out to where people are actually located, it will not only allow us to provide access to medication for opiate use disorder, but it will also allow us to address their other medical needs at the same time, particularly HIV,” Dr. Siegel continued. “And if they are not HIV positive, we can provide them with pre-exposure prophylaxis, so that they don’t acquire HIV.”
Dr. Kuo added that the offer of pre-HIV exposure prophylaxis is “one of the most interesting aspects of the study." The CDC has issued recommendations for physicians to provide pre-exposure prophylaxis to people who inject drugs, especially those who share needles or have sex with HIV-positive partners or with partners in which their HIV status is unknown. However, it's a recommendation that rarely is acted on, according to Dr. Kuo.
If the study volunteers test negative for hepatitis A and B, the team will refer the volunteers to be vaccinated because both diseases are at increased prevalence among people with opiate use disorder. If they test positive for hepatitis C, which is prevalent among people who inject drugs, the medical staff will refer them for treatment.
This study also looks to advance addiction science by determining the most effective way to integrate HIV care and prevention, opioid use disorder treatment and other health care in a way that will overcome the barriers that prevent those most in need from accessing services. Participants enrolled in the study will be followed for one year. The results from overall study are expected in 2025.