A combination intervention that included standard of care antiretroviral therapy (ART), systems navigation, and psychosocial counseling showed success in HIV-infected people who inject drugs (PWID), according to the results of a randomized study in the Lancet.
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The intervention patients showed an increase in both the use of ART and medication-assisted treatment (MAT) for drug use. In addition, they showed a reduced mortality, compared with standard-of-care controls. The study was carried out in one community site in the Ukraine and two health center sites in Vietnam.
A unique aspect of the study was that each HIV-positive PWID recruited one or more HIV-negative injection partners who were followed throughout the study to determine any change in their HIV status, according to a report by William C. Miller, MD, PhD, of the Ohio State University, Columbus, and his colleagues.
The study included 502 eligible and enrolled HIV-positive PWID along with 806 eligible and enrolled injection partners. The subjects comprised 85% men, with 65% of the participants between the ages of 30-39 years at time of enrollment. Patients were randomized to the intervention group (25%) or the standard of care–only group (75%).
At 1 year, self-reported ART use was higher among the index participants in the intervention group than in the standard of care group (probability ratio,1.7; 95% confidence interval, 1.4-1.9) and viral suppression also was higher with the intervention group than with standard of care (PR 1.7; 95% CI, 1.3-2.2). In addition, MAT use was higher with the intervention than with standard of care (PR, 1.7; 95% CI, 1.3-2.2). Seven HIV infections occurred during the study, all in the injection partners of the standard of care group, with none in the intervention group partners, but the study was not powered to determine if this was a significant difference.
Mortality was lower in the intervention group than in the standard of care group with 5.6 deaths/100 person-years (95% CI, 2.6-10.6) in the intervention group vs. 12.1 deaths/100 person-years (95% CI, 9.1-15.6) in the standard of care group (hazard ratio, 0.47; 95% CI 0.22-0.90). Similarly, mortality also was lower among injection partners in the intervention group than in the standard of care group (0.46 deaths/100 person-years; 95% CI, 0.01-2.6 vs. 2.6 deaths/100 person-years; 95% CI, 1.5-4.1, respectively (HR, 0.17; 95% CI, 0.01-0.84).
“This vanguard study provides evidence that a flexible, scalable intervention increases ART and MAT use and reduced mortality among PWID,” according to the authors. “The intervention might have reduced HIV incidence, but incidence was low in both groups of uninfected partners. This low incidence presents a challenge for any similar future trial assessing transmission and precludes a future randomized controlled trial,” they concluded.
The study was funded by the National Institutes of Health and the authors reported no conflicts of interest within the scope of the study.
SOURCE: Miller WC et al. Lancet 2018;392:747-59.