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

Официальное название

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)

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат 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

Первичные конечные точки

• Number of Participants with Viral Suppression Out of Total Participants [Срок оценки: 3 months]

Вторичные конечные точки (2)

• Number of Participants with Adherence Out of Total Participants [Срок оценки: 3 months]
• Number of Participants Retention Out of Total Participants [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06704204 · 20241441 · R34DA057165

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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