Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04296331 |
| Other study ID # |
2020-12451 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2019 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Montefiore Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
"Enhancing a universal testing and treatment strategy in jail to promote viral load
suppression among justice-involved people living with HIV" is an observational research study
led by Dr. Matthew Akiyama, MSc of Albert Einstein College of Medicine and Montefiore Medical
Center and Dr. Anne Spaulding, MPH of Emory University's Rollins School of Public Health. Due
to the high rates of undiagnosed Human Immunodeficiency Virus (HIV) in the correctional
setting and the short length of stay in jails, this study aims to evaluate whether care
coordination within the D.C. Central Detention Facility (DC DOC) and upon release, including
testing procedures and antiretroviral therapy (ART) initiation, can improve the connection of
adults (age 18 and over) living with HIV to care in the community.
The researchers will retrospectively look at the aggregate-level de-identified data of
roughly 3,000 individuals admitted to the DC DOC over a 6-month period to determine the most
effective HIV diagnostic test for routine opt-out testing in the correctional setting. Over
the course of these 6 months, the correctional facility will transition from using POC only
to POC + antigen/antibody (Ag/Ab), to solely using Ag/Ab, each for a 2-month duration.
Individuals from this time period who are identified by corrections staff as HIV-positive
either through testing upon admission, their electronic medical record (EMR) or self-report,
and have a known release date will be considered eligible for the follow-up study to assess
if care coordination is effective in linking others with HIV leaving the DC DOC to care. This
follow-up will enroll 100 of these individuals who have consented to participate following
their release from the DC DOC, and will consist of a chart review of their DC DOC EMRs and
those from their community healthcare provider for up to two years after their release.
Description:
This study will be the first to assess the feasibility, process measures, and estimate
cost-effectiveness of a rapid Universal Testing and Treatment (rUTT) intervention in a large
urban jail located in Washington, DC - 1 of the 50 communities targeted for End the HIV
Epidemic (EtHE) efforts. The aim is to determine the most effective HIV diagnostic test to
use for routine opt-out testing in the correctional setting.
The investigators hypothesize that the combination of opt-out POC and Ag/Ab tests offered at
intake will maximize the yield of PLWH detected, provision of test results, ART initiation,
viral suppression, and cost-effectiveness.
The investigators will examine administrative, de-identified, aggregate data for
approximately 3000 individuals (based on 500 individuals currently accepting HIV testing per
month) over 6 months. For individuals who provide consent to release their jail medical
records after incarceration, the investigators will retrieve the mean time from: 1) positive
test to receipt of test results, 2) receipt of test results to first dose of ART in jail, 3)
receipt of post-test counseling to meeting the discharge planner, and 4) ART initiation to
viral suppression defined as a viral load <200 copies/mL. The investigators will calculate
the implementation costs of each strategy using observation of staff time, market values for
items used in the intervention, and process measure data collected through chart review (for
individuals who consent to release their jail medical records after incarceration). Units of
resource items, such as staff time and diagnostic tests, will be multiplied by their unit
costs to calculate total costs.
This protocol does not constitute research involving prisoners (as outlined by the U.S.
Department of Health & Human Services Office for Human Research Protections -
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/prisoner-research/index.html)
since the investigators will not be:
1. Obtaining identifiable private data or information about prisoner subjects through
intervention or interaction with them while incarcerated.
2. Seeking the informed consent of prisoners to be subjects in research;
3. Using, studying or analyzing, for research purposes, identifiable private information
about prisoners, or identifiable specimens obtained from prisoners; or
4. Surveying prisoners for this research study.
The overarching goal of this pilot study is to assess 3 HIV testing strategies as the entry
point into a rUTT jail-based intervention to promote HIV viral suppression among individuals
with undiagnosed and diagnosed HIV infections. Among individuals within the DC Department of
Corrections (DC DOC) the investigators will examine whether opt-out Point-of-Care (POC) rapid
testing, 4th generation laboratory-based antigen/antibody testing (Ag/Ab), or POC and Ag/Ab
testing are most effective in identifying HIV infection upon entry into the jails, linking
persons to care and obtaining viral load suppression. During the medical intake, jail nurses
will sequentially use, for 2 month each: 1. POC only; 2. POC + Ag/Ab; 3. Ag/Ab only as part
of standard clinical care (POC: INSTI® rapid test; Ag/Ab: ARCHITECT® laboratory-based test).
Upon anticipation of release, those who are on ART will be invited to participate in a
follow-up study regarding their coordination of care while in the DC DOC system and
post-release, as well as their current viral load status.
The specific aims are: (1) Compare the feasibility of 3 testing strategies using
administrative, de-identified, aggregate data to measure the number/percentage of entrants
who do not opt out of testing and receive their test results in jail. (2) Compare 3 testing
strategies for time to return of preliminary and confirmed test results, jail-based ART
initiation (or reinitiation in known PLWH), and referral to discharge planners among
justice-involved PLWH who consent to release their jail medical records after incarceration.
(3) Assess the cost of implementing each testing strategy and relative cost-effectiveness of
the 3 testing strategies in terms of process measures, time to ART initiation, and viral
suppression.
Setting and location The DC DOC is a large urban jail with nearly 8000 intakes per year and
an average daily population of approximately 2000 individuals. It is estimated that the HIV
prevalence in this system is approximately 4% with a mean of 60 known PLWH in the population
at any given time. About 1-3 new HIV diagnoses are made each month with the current POC HIV
testing program in place. The patient population is predominantly racial/ethnic minorities
(97% overall; 88% Black, 20% Hispanic - not mutually exclusive due to more than 1
race/ethnicity), and 91% are at or below the 200% poverty level (HRSA, 2017). As part of the
Unity Health Care (UHC) clinical program, individuals with newly diagnosed HIV will be
offered rapid ART initiation, ideally within 24-72 hours of diagnosis with an integrase
inhibitor-based regimen as per Department of Health and Human Services(DHHS) guidelines
("Guidelines",2019). Individuals who are known to be HIV-positive through the electronic
medical record (EMR) or self-report do not undergo HIV testing. For those who are
ART-experienced, the individual's existing ART regimen is restarted. If ART-naïve, an
integrase inhibitor-based regimen will be started within 24-72 hours. Community follow-up is
offered within 1-2 weeks of reentry and supported by jail discharge planners and community
health workers (CHWs). UHC recently began a new 5-year contract to provide jail health
services, ensuring a consistent healthcare provider for the duration of this study. DC has
expanded Medicaid, which is an essential to developing an rUTT model since it is imperative
to ensure no break in ART coverage. Potential participants for this study will be recruited
from the DC DOC system
It is estimated that aggregate-level data will be collected for 3,000 individuals who are
admitted to the DC DOC system over the 6-month study period and accept HIV testing upon
entry. Of those tested, preliminary eligibility will be based on the following criteria:
1. Admitted to DC DOC between October 14th, 2019 and October 31st, 2020
2. Has initiated ART by time of release
3. Being HIV-positive: confirmed either through HIV testing upon entry, was known to be
HIV-positive through the EMR, or self-reported being HIV-positive
For the past 12 years DC DOC has offered opt-out POC testing with the INSTI® finger stick
test at entry. During booking (in the intake medical evaluation unit, prior to processing
individuals into jail) jail nurses will sequentially use, for 2 month each: 1. POC only; 2.
POC + Ag/Ab; 3. Ag/Ab only as part of standard clinical care (POC: INSTI® rapid test; Ag/Ab:
ARCHITECT® laboratory-based test). To assist UHC with this transition, the investigators have
secured in-kind donation of INSTI® rapid test kits (see letter of support). Over 6 months of
testing the investigators anticipate approximately 3000 individuals will be tested (based on
500 individuals currently accepting HIV testing per month). The number of new HIV diagnoses
that will be made is not known; however, the investigators anticipate the number will be
higher using Ag/Ab testing than the 1-3 new diagnoses that are made each month using the
current POC rapid testing strategy.
After each of the 3 testing phases the project team will request, from DC DOC, data from
their EMR. Specifically, they will request administrative, de-identified, aggregate data that
does not contain any of the 18 Health Insurance Portability and Accountability Act (HIPAA)
identifiers for: 1) the total number of entrants, 2) the number of entrants with HIV test
results (indicating they have not opted out of testing), 3) the number of post-test
counseling visits (indicating receipt of test results), 4) the number of positive HIV tests,
and 5) the median and mean length of stay for the entire population. The individuals for whom
these data are available and are on ART at time of jail release are considered "EMR-eligible
participants." Aggregate-level data will be collected on all individuals admitted to DC DOC
beginning January 15th, 2019.
Participants for the post-release portion of the study will be recruited at exit from the DC
DOC system. Currently the DC DOC provides all patients who are on ART with a 30-day supply
upon release. Inmates who are released and have entered the jail during the study period will
receive an invitation letter to participate in the study that will be attached to their
30-day supply of ART, which they will pick up at release.
'Invitation to Participate Letters' from UHC will inform EMR-eligible participants that they
may be eligible to participate in a paid observational research study about the effectiveness
of opt-out rUTT strategies for HIV (see attached letter). Potentially eligible participants
are instructed to contact the UHC research coordinator (RC) if they are interested in being a
part of the study, or to find out more information. The letter will state that for this
observational study participants will only have to continue their standard HIV care with
their provider. They will only have to meet with the study team once in order to conduct the
eligibility screening and sign the informed consent authorizing the study team to receive the
participants EMR from DC DOC and their community provider for two years following their
release.
