Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community

Not yet recruiting

• Conditions: HIV
• Interventions: Drug: 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

• Registration Number: NCT06704204
• Lead Sponsor: The Miriam Hospital

Brief Summary

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.

Detailed Description

R34-funded mixed methods study that will develop and pilot test an LAI ART protocol designed specifically for PWH who are experiencing community re-entry

Study Timeline

• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Study First Posted: 2024-11-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Study Start: 2025-02
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1. ≥18 years of age; 2) English speaking; 3) HIV positive (confirmed by medical record review); 4) receiving oral ART; 5) documentation of HIV viral suppression (< 50 copies/mL) on oral ART within 12 weeks of recruitment; 5) eligible to transition from oral ART to injectable CAB/RPV based upon medical record review and pre-treatment evaluation; 6) willing to transition ART to injectable CAB/RPV; 7) anticipated release from MDPSCS facility within 12 weeks; 8) anticipated release to Baltimore City; 9) willing to receive post-release CAB/RPV injections at community-based sites; and 10) able to provide informed consent for study participation.

Exclusion Criteria

• Persons who are currently prescribed injectable CAB/RPV within MDPSCS will not be eligible for study enrollment, however, we do not anticipate use of injectable CAB/RPV will be common in this population during the conduct of this study given slow roll out in the community to date and no experience within carceral facilities. Potential participants unable to provide informed consent, including people with severe mental illness (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed) requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia), will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
people with HIV (PWH) who are experiencing community re-entry	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	ART is highly effective in controlling HIV and can significantly reduce HIV transmission when viral suppression is achieved. ART is usually administered as a combination of antiretroviral medications taken orally daily. Despite the convenience of single pill fixed-dose ART regimens, many persons, including justice involved substance users, struggle with daily ART adherence and consequently experience disease progression, emergence of HIV resistance, and contribute to HIV transmission. Long-acting injectable (LAI) ART is a new alternative to help overcome the challenges of adhering to daily pills. LAI ART is administered by intramuscular injection every four weeks and the first LAI regimen, cabotegravir (CAB) combined with rilpivirine (RPV), was FDA-approved in January 2021 for treatment of HIV infection. While rollout of LAI ART has recently begun, using LAI ART among PWH during the challenging community re-entry period has the substantial potential to improve HIV treatment outcomes.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Viral Suppression Out of Total Participants	3 months	HIV viral load

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adherence Out of Total Participants	3 months	adherence to LAI ART medication
Number of Participants Retention Out of Total Participants	3 months	Loss to follow up (LTFU)