To determine if extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among incarcerated individuals with HIV and alcohol use disorders (AUDs) transitioning to the community.Design:
A randomized double-blind, placebo-controlled trial was conducted among incarcerated individuals with HIV and AUDs transitioning to the community from 2010 through 2016.Methods:
Eligible participants (N=100) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n=67) or Placebo (n=33) starting at release and continued for 6 months. The primary and secondary outcomes were the proportion that maintained or improved VS at <200 copies/mL and <50 copies/ml from baseline to 6 months respectively using an intention to treat analysis.Results:
Participants allocated to XR-NTX improved VS from baseline to six months for <200 copies/mL (48.0% to 64.2%, p=0.024) and for <50 copies/mL (31.0% to 56.7%, p=0.001); while the placebo group did not (<200 copies/mL: 64% to 42.4%, p=0.070; <50 copies/mL: 42.0% to 30.3%, p=0.292). XR-NTX participants were more likely to achieve VS than placebo at six-months (<200 copies/mL: 64.2% vs. 42.4%; p=0.041; <50 copies/mL: 56.7% vs. 30.3%; p=0.015). XR-NTX independently predicted VS (<200 copies/mL: aOR=2.68, 95%CI=1.01-7.09, p=0.047; <50 copies/mL: aOR=4.54; 95% CI=1.43-14.43, p=0.009) as did receipt of ≥3 injections (<200 c/mL: aOR=3.26; 95% CI=1.26-8.47, p=0.010; <50 c/mL: aOR=6.34; 95%CI=2.08-19.29, p=0.001). Reductions in alcohol consumption (aOR=1.43; 95% CI=1.03-1.98, p=0.033) and white race (aOR=5.37; 95% CI=1.08-27.72, p=0.040) also predicted VS at <50 copies/mL.Conclusion:
XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV and AUDs.