Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community

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Persons who experience incarceration in the United States are disproportionately impacted by HIV infection and substance use disorders (SUD) and are at increased risk of having poor health outcomes. The time of release from carceral settings, known as community re-entry, is a period of particularly high risk for persons with HIV (PWH). New and creative approaches to sustaining HIV treatment and viral suppression during community re- entry are urgently needed. Antiretroviral treatment (ART) is highly effective in controlling HIV and can significantly reduce HIV transmission. However, justice involved PWH often struggle with daily ART adherence during community re-entry and consequently experience disease progression and contribute to HIV transmission. Long- acting injectable (LAI) ART is a new alternative to help overcome the challenges of adhering to daily pills. The first FDA-approved LAI ART regimen, cabotegravir (CAB) and rilpivirine (RPV), is administered by intramuscular injection every four weeks. There is an immediate opportunity to investigate whether using LAI ART, as opposed to daily oral ART, has a unique and important role when initiated in carceral settings and continued during community re-entry with the goal of improving treatment outcomes. We propose a mixed methods study that will develop and pilot test an LAI ART protocol designed specifically for community re-entry. This study will be conducted in collaboration with the Maryland Department of Public Safety and Correctional Services, Corizon Health (state prison medical contractor), and Total Health Care, a Federally Qualified Health Center in the Baltimore Metropolitan area, an Ending the HIV Epidemic geographic hotspot. Framed by the Behavioral Model for Vulnerable Populations, our aims include: 1) Conduct interviews with justice and treatment experienced 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 on oral ART to LAI ART in prison with continuation during community re-entry. 2) Develop an initial LAI ART community re-entry protocol and conduct an open label pilot study that will follow 10 incarcerated PWH eligible for LAI ART who are near release from prison for three months in order to optimize protocol procedures and to pilot study retention methods and assessments. 3) Following optimization of protocol, conduct a pilot randomized controlled trial among 50 incarcerated PWH eligible for LAI ART and scheduled to be released from prison; participants will be randomized 1:1 to transition ART to injectable CAB/RPV or continue 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 continuance of the assigned LAI or oral ART regimen, ART adherence, and substance use. This study will provide preliminary data to inform the design of a future multi-site fully powered clinical trial that will compare LAI ART to daily oral ART during community re-entry on sustaining HIV viral suppression after release from prison.