FRI is pleased to announce that Drs. Michael S Gordon (MPI) and Thomas R. Blue (Co-I), along with Dr. Curt Beckwith (MPI) from The Miriam Hospital/Rhode Island Hospital and Alpert Medical School of Brown University and Dr. Lauren Brinkley-Rubinstein (MPI), from the Social Medicine at UNC—Chapel Hill have received a three-year R34 grant from the National Institute on Drug Abuse entitled, Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community. The study will be conducted in in collaboration with the Maryland Department of Public Safety and Correctional Services (MD DPSCS) and Total Health Care.
The study has three specific aims. Aim 1: Conduct interviews with justice and treatment experienced persons living with HIV (PWH) (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition PWH with viral suppression on oral anti-retroviral therapy (ART) to long-acting injectable ART in prison with continuation during community re-entry. Aim 2: Develop an initial LAI ART community re-entry protocol based on Aim 1 findings and conduct an open label pilot study. Post-release follow up will occur for three months among 10 incarcerated PWH eligible for LAI ART who are near release from prison in order to optimize protocol procedures including participant recruitment, initiation of LAI ART in prison, transition of LAI ART to community providers, and to evaluate study retention methods and assessments, including post-release HIV viral loads and urine drug testing, during the follow-up period. Aim 3: Following optimization of the LAI ART community re-entry protocol, conduct a pilot RCT among 50 incarcerated PWH eligible for LAI ART and scheduled to be released from prison; participants will be randomized 1:1 to transition cabotegravir (CAB), the first FDA-approved LAI ART regimen, or continue their daily oral ART regimen through a six-month follow-up period after release. During the follow-up period, we will assess the primary outcome of HIV viral suppression and secondary outcomes including ART adherence, substance use, and continuance of the assigned LAI or oral ART regimen.