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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Michael S Gordon, BS, MS, DPA; Phone Number: 800-705-7757; Email: mgordon@friendsresearch.org
• Study Contact Backup: Name: Curt G Beckwith, MD; Phone Number: 1+ 401-793-4397; Email: cbeckwith@brownhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from participating carceral settings through direct referral from carceral HIV providers. We will plan to enroll women and men for the open label pilot study to ensure we gain experience with recruitment from facilities for both women and men. In addition, recruitment of women study participants at this stage will be important given additional eligibility requirements for women being considered for injectable CAB/RPV (pregnancy considerations following release).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

people with HIV (PWH) who are experiencing community re-entry; 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.

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; To date, there have been no studies looking at the use of LAI ART among justice involved PWH, yet a significant opportunity exists to improve HIV treatment outcomes in this high risk population.30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Viral Suppression Out of Total Participants	HIV viral load	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adherence Out of Total Participants	adherence to LAI ART medication	3 months
Number of Participants Retention Out of Total Participants	Loss to follow up (LTFU)	3 months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Curt G Beckwith, MD, The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: HIV infection; HIV treatment; incarceration; long-acting injectable; substance use disorders; community re-entry
• Additional Relevant MeSH Terms: Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Rilpivirine; Integrase Inhibitors; Reverse Transcriptase Inhibitors; Cabotegravir; HIV Integrase Inhibitors
• Other Study ID Numbers: 20241441; R34DA057165 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study population are vulnerable population, including people with HIV (PWH) and incarcerated individuals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No