Researchers from the University of North Carolina Gillings School of Global Public Health are part of an international team reporting promising findings related to the prevention of HIV transmission among a population of people who are HIV-positive and use injectable drugs and their partners.
Dr. Myron Cohen, professor of epidemiology at the Gillings School and Yeargan-Bate Eminent Distinguished Professor of Medicine, Microbiology and Immunology in the UNC School of Medicine, is HPTN co-principal investigator. Dr. Cohen also is director of UNC’s Institute for Global Health and Infectious Diseases.
Gillings School co-authors of the published study include Dr. Tran Ha, assistant professor of health behavior; Dr. Vivian Go, professor of health behavior; Ms. Katie R. Mollan, epidemiology doctoral student and biostatistics core manager at the UNC Center for AIDS Research; Ms. Sarah A. Reifeis, biostatistics doctoral student; and Dr. Michael Hudgens, professor of biostatistics.
The HPTN 074 study assessed an integrated intervention combining psychosocial counseling and supported referrals for antiretroviral therapy at any CD4 cell count and substance use treatment for people living with HIV who inject drugs, compared to the locally available standard of care. The primary objectives of the study included estimating incidence in the standard of care group, while assessing the uptake of an integrated HIV prevention intervention.
At 52 weeks post-enrollment, participants in the intervention group of the study nearly doubled their antiretroviral therapy usage, viral suppression and medication-assisted treatment usage compared to the group being provided the standard of care. Mortality also was reduced by more than half with the intervention.
HPTN 074 was a randomized, controlled trial conducted among people who inject drugs in Ukraine, Indonesia and Vietnam. Overall, 502 people living with HIV and 806 people with whom they injected drugs entered the study over 15 months and were followed for 12 to 24 months after enrollment. The median age was 35 years. Eighty-five percent of participants enrolled were men; most of the women who participated in the study were enrolled in Ukraine.
At week 26, intervention participants were twice as likely to report antiretroviral therapy use, compared to the standard of care arm participants, and twice as likely to achieve an undetectable viral load. The effects persisted at week 52.
Among intervention group participants at week 52, self-reported substance use treatment uptake was higher, compared to the standard of care arm participants. Mortality was significantly lower among intervention participants and their partners compared to the standard of care arm participants and their partners. For partners of intervention participants, no new HIV infections were observed, while seven were observed among partners in the standard of care group.
HPTN 074 study sites have completed a one-year study extension, which ended July 6. Due to the strength of the preliminary study results, all sites began offering the integrated intervention to participants who had not initiated antiretroviral therapy and substance use therapy in the standard of care arm in late 2017.
“The HPTN 074 integrated systems navigation and psychosocial counseling intervention had a positive impact on antiretroviral therapy use, viral suppression and medication-assisted treatment use, and lengthened the lives of people who inject drugs,” said Ms. Mollan. “The intervention also appeared to lengthen the lives of the injecting HIV-negative partners. Notably, there was site-to-site variability in the intervention effects that will be of interest to researchers looking to scale up this intervention.”
Dr. Cohen said the study findings related to antiretroviral therapy use and HIV prevention are promising. “These and other interventions are needed to get people living with HIV who inject drugs into care for their own health and to stop transmission of the virus.”
HPTN 074 is funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), and the U.S. National Institute on Drug Abuse (NIDA), both part of the U. S. National Institutes of Health (NIH).
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection.
The HPTN research agenda is focused primarily on the use of integrated strategies – use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioral risk reduction interventions and structural interventions. NIAID, NIDA and the NIH’s National Institute of Mental Health co-fund the HPTN.
[Photo: (Left to right) Dr. Myron Cohen, Ms. Katie Mollan, Dr. Vivian Go and Dr. Tran Ha]