Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community (Study #3; Aim 2 Injectable CAB/RPV Pilot)

NCT06704204 NOT_YET_RECRUITING

The federal research award entitles "Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community" aims to 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 with viral suppression on oral ART to LAI ART in prison with continuation during community re-entry; 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 20-30 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 pilot study retention methods and assessments, including post-release HIV viral loads and urine drug testing, during the follow-up period.

Details

Lead sponsor	The Miriam Hospital
Status	NOT_YET_RECRUITING
Enrolment	20
Start date	2025-02
Completion	2025-07-31

Conditions

• HIV

Interventions

• The first FDA-approved LAI ART regimen includes an integrase inhibitor, cabotegravir (CAB), and a non-nucleoside reverse transcriptase inhibitor, rilpivirine (RPV) combined 4 wks

Primary outcomes

• Number of Participants with Viral Suppression Out of Total Participants — 3 months
  HIV viral load