Linking Persons With HIV, Discharged From Jail, With Community Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-10

Study Completion Date

2021-11-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HIV Jail POC-AgAB Testings

NCT04296331

HIV/AIDS

COMPLETED

A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections

NCT01366495

HIV

COMPLETED NA

Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK

NCT04064567

HIV/AIDS Pre-exposure Prophylaxis

COMPLETED NA

CARE Corrections: Technology for Jail HIV/HCV Testing, Linkage, and Care (TLC)

NCT01721226

Human Immunodeficiency Virus

COMPLETED NA

Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks

NCT03293290

HIV Infections

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

POC Testing Alone

POC HIV testing (the current standard of care) will be conducted for persons entering jail during the first two-month period.