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Early Versus Delayed Routine HIV Testing in Connecticut Jails (SWAB)

Primary Purpose

HIV Infections

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
routine HIV testing
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HIV Infections focused on measuring routine HIV testing, jails, criminal justice system, substance abuse, mental illness, HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All newly incarcerated inmates will be eligible for this study.

Exclusion Criteria:

  • None.

Sites / Locations

  • New Haven Community Correctional Center
  • York Correctional Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Immediate

Following Day

Delayed

Arm Description

Individuals assigned to be approached for routine HIV testing immediately upon admission to the jail.

Individuals assigned to be approached for routine HIV testing the day following admission to the jail.

Individuals assigned to be approached for routine HIV testing several days following admission to the jail.

Outcomes

Primary Outcome Measures

The proportion of individuals in each testing group who are orally swabbed and consented to rapid HIV testing.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2008
Last Updated
October 16, 2014
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00624247
Brief Title
Early Versus Delayed Routine HIV Testing in Connecticut Jails
Acronym
SWAB
Official Title
Early Versus Delayed Routine HIV Testing in Connecticut Jails
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this non-randomized, controlled, trial is to evaluate the optimal time to approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that maximizes the number of individuals able to demonstrate capacity to consent and willingness to receive HIV testing.
Detailed Description
Primary outcome: proportion of individuals in each assigned group that agree to be swabbed for HIV testing and are able to consent to the study. The prevalence of HIV infection in the United States is four times greater in correctional settings compared to the general population. Because prisons and jails house a population facing a disproportionate share of the burden of HIV infection, these facilities serve as important sites for the testing and treatment of HIV. The Center for Disease Control and Prevention's recent recommendations to implement routine opt-out HIV testing in all healthcare settings presents an important challenge and opportunity to correctional institutions. By effectively implementing routine opt-out testing, correctional facilities can expand HIV testing to one of society's most at-risk populations. Subsequently, testing can lead to appropriate access to counseling and treatment both within the correctional setting and upon release into the community. Although jails interact with a larger number of individuals at risk for HIV infection than do prisons, they also pose unique logistical and health-related constraints in several important ways that impact HIV testing strategies. Jail populations experience short periods of incarceration and high rates of turnover with many-fold greater admissions and discharges. Jails also house individuals with higher rates of acute intoxication from psychoactive drugs, uncontrolled mental illness, and suicidal behavior. The suicide rate in jails is three times that in state prisons; nearly a quarter of these suicides take place within the first 48 hours of admission. Furthermore, the individuals who enter jails have higher recent risk behaviors for HIV than those in prisons. Given these considerations, a major challenge to implementing routine opt-out HIV testing in jails is choosing the optimal time to conduct testing. The timing of delivering non-emergent, traumatically emotional health information (such as a preliminary positive result in an asymptomatic patient) must be carefully considered. Recently incarcerated inmates might be too intoxicated or psychologically distressed to demonstrate capacity to consent to or opt out of routine testing, and may be unprepared to consider and respond to the consequences of a preliminary positive HIV test result. Likewise, the challenge with postponing testing is that many individuals experience very short stays in jail, with approximately one-third leaving within 48 hours, followed by further attrition daily for the first week and may lose the opportunity for getting life-saving information in a timely manner. Therefore, the objective of this study is to evaluate the optimal time to approach newly incarcerated jail inmates for routine opt-out HIV testing in a manner that maximizes the number of individuals able to demonstrate capacity to consent and willingness to receive HIV testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
routine HIV testing, jails, criminal justice system, substance abuse, mental illness, HIV

7. Study Design

Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
621 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Other
Arm Description
Individuals assigned to be approached for routine HIV testing immediately upon admission to the jail.
Arm Title
Following Day
Arm Type
Other
Arm Description
Individuals assigned to be approached for routine HIV testing the day following admission to the jail.
Arm Title
Delayed
Arm Type
Other
Arm Description
Individuals assigned to be approached for routine HIV testing several days following admission to the jail.
Intervention Type
Other
Intervention Name(s)
routine HIV testing
Intervention Description
Potential subjects are offered swabbing as part of HIV testing by jail medical staff or study staff. All potential subjects are told HIV results can now be made available within a short period of time using an oral swab. Anyone not wanting HIV test results is allowed to refuse at the time of offering the HIV test and not be swabbed. If the inmate agrees to be swabbed and tested, he or she then meets with a member of the research study staff who discusses two separate informed consents - one for study participation and one for HIV testing.
Primary Outcome Measure Information:
Title
The proportion of individuals in each testing group who are orally swabbed and consented to rapid HIV testing.
Time Frame
Immediately, the following evening, and 7 days post-entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All newly incarcerated inmates will be eligible for this study. Exclusion Criteria: None.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick L Altice, MD
Organizational Affiliation
Yale University AIDS Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Haven Community Correctional Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
York Correctional Institution
City
Niantic
State/Province
Connecticut
ZIP/Postal Code
06357
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19946371
Citation
Kavasery R, Maru DS, Sylla LN, Smith D, Altice FL. A prospective controlled trial of routine opt-out HIV testing in a men's jail. PLoS One. 2009 Nov 25;4(11):e8056. doi: 10.1371/journal.pone.0008056.
Results Reference
background
PubMed Identifier
19946370
Citation
Kavasery R, Maru DS, Cornman-Homonoff J, Sylla LN, Smith D, Altice FL. Routine opt-out HIV testing strategies in a female jail setting: a prospective controlled trial. PLoS One. 2009 Nov 25;4(11):e7648. doi: 10.1371/journal.pone.0007648.
Results Reference
background

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Early Versus Delayed Routine HIV Testing in Connecticut Jails

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