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

NCT06704204 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Curt G Beckwith, MD · The Miriam Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06704204 on ClinicalTrials.gov