NCT06704204Not yet recruiting
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)
Source: ClinicalTrials.gov · Last updated 15 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- Feb 2025
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- The Miriam Hospital
- Diseases
- HIV
- NCT number
- NCT06704204
What you commit to
- Study type: Observational
- Planned participants: 20
- From Feb 2025 to the primary completion date, 31 Jul 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.