Clinical trial NCT04560556: Linking Persons With HIV, Discharged From Jail, With Community Care
Official title: Linking Persons With HIV, Discharged From Jail, With Community Care: a Direct Comparison of the Costs and Effects of Three HIV Management Strategies in the District of Columbia Department of Corrections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Correctional settings
HIV/AIDS
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-09-23
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled from the study population of NCT04296331, comprised of individuals admitted to D.C. Central Detention Facility (DC DOC) between October 2019 and April 2021.

Brief summary: This is a prospective cohort study of outcomes of individuals who entered jail during a period during which one of three serial HIV testing strategies is implemented. This study involves two sub-studies. One sub-study will examine referrals to HIV prevention programs for persons testing negative for HIV while in jail. The second sub-study will monitor antiviral use among those testing positive for HIV.

Detailed description: Incarcerated Americans on any given day represent one in 40 (2.5%) Persons Living with HIV (PLWH) in this country, but those ever incarcerated over the course of a year represent 17% of the US epidemic. PLWH are a diverse group in terms of awareness and management of their disease. A portion may be aware of their HIV status and on treatment. This subgroup is at risk of disruption in care if incarcerated. Others may be aware of their status, but untreated, while still others may be unaware of their HIV status. The latter group is of particular importance in terms of the HIV epidemic in criminal justice settings, as a recent meta-analysis indicated that up to 15% of individuals entering jail have undiagnosed infections.

Good management of PLWH during a period of incarceration is critical. Ensuring that care relationships are maintained or newly established will improve health outcomes among PLWH and reduce the risk of transmission once they are discharged. As the median length of stay in jail is short (median \< 7 days), rapid HIV testing is critical. Maximizing the yield and speed of HIV testing in a jail environment has the potential to promote rapid entry into care, or rapid re-engagement if persons have fallen out of care. For those testing negative, it can hasten the referral to Pre-Exposure Prophylaxis (PrEP) services.

How correctional facilities offer HIV testing and begin treatment affects long-term outcomes. Because of the rapid churn of jail, point-of-care (POC) rapid testing may lead to a higher percentage of patients receiving test results before leaving jail, compared to conventional assays. Fourth generation laboratory-based antigen/antibody (Ag/Ab) testing can diagnosis more persons with acute HIV infection, who may be in the window period before the POC test turns positive, but has a several hour test turn-around time, and those tested may leave jail before receiving their result. Using both tests for every entrant would permit the jail to experience the benefit of both methods but at greater expense. Collaborating with Washington, DC's city jail, known as DC Department of Corrections (DC DOC), and Unity Healthcare, the network of Federally Qualified Health Centers in Washington DC, which also provides care within the DC DOC, this study has a unique opportunity to measure rapidity of testing, linkage to and commencement of care, and achievement of viral suppression, along with costs of HIV identification.

This study uses a unique, time-sensitive opportunity to compare three separate strategies of universal HIV screening and treating. The strategies of POC testing, 4th generation laboratory-based Ag/Ab testing, and a combination of the two tests will be compared in the DC jail. A rigorous assessment of the three strategies in terms of their feasibility, process measures, and cost-effectiveness on an institutional level will help to guide implementation decisions in jails across the US.

One sub-study will assess the number of persons testing negative who are referred to prevention programs after leaving the jail. A second sub-study will examine antiviral use after jail release, among PLWH.

Eligibility criteria: Inclusion Criteria for Those Testing Negative for HIV:

* Able to understand and speak English
* Confirmed HIV negative status
* Planning to stay in the metropolitan DC area upon jail release
* Candidate for PrEP using attached screening instrument and interested in taking it

Inclusion Criteria for Those Testing Positive for HIV:

* Able to understand and speak English
* Confirmed HIV positive status
* Planning to stay in the metropolitan DC area upon jail release

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Entrants Tested
timeFrame: Up to 24 hours
measure: Percentage of PLWH Identified in First 24 Hours
timeFrame: Up to 24 hours
measure: Number of New HIV Diagnosed Prior to Discharge
timeFrame: Up to Jail Discharge
measure: Number of Entrants with Acute HIV Infection Identified
timeFrame: Up to 5 days
Secondary outcomes:
measure: Time Until Receipt of Positive Test Result
timeFrame: Up to 5 days
measure: Time Until Receipt of Antiviral Dose
timeFrame: Up to Jail Discharge
measure: Time Until Viral Suppression
timeFrame: 6 months after positive HIV intake test
measure: Time Until Meeting with Discharge Planner
timeFrame: Up to Jail Discharge
measure: Number of Participants Taking PrEP
timeFrame: 2 months after jail release, 6 months after jail release
measure: Number of PLWH who Attend Clinic Visits
timeFrame: 1 year
measure: Number of PLWH with Viral Suppression
timeFrame: 6 months
measure: Cost of Each Testing Strategy
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: DC Department of Corrections
state: District of Columbia
Study officials:
affiliation: Emory University
name: Anne Spaulding, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: