Early Versus Delayed Routine HIV Testing in Connecticut Jails
SWAB
1 other identifier
interventional
621
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2007
Shorter than P25 for early_phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 18, 2008
CompletedFirst Posted
Study publicly available on registry
February 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedOctober 17, 2014
February 1, 2009
8 months
February 18, 2008
October 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of individuals in each testing group who are orally swabbed and consented to rapid HIV testing.
Immediately, the following evening, and 7 days post-entry
Study Arms (3)
Immediate
OTHERIndividuals assigned to be approached for routine HIV testing immediately upon admission to the jail.
Following Day
OTHERIndividuals assigned to be approached for routine HIV testing the day following admission to the jail.
Delayed
OTHERIndividuals assigned to be approached for routine HIV testing several days following admission to the jail.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All newly incarcerated inmates will be eligible for this study.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
New Haven Community Correctional Center
New Haven, Connecticut, 06511, United States
York Correctional Institution
Niantic, Connecticut, 06357, United States
Related Publications (2)
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.
PMID: 19946371BACKGROUNDKavasery 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.
PMID: 19946370BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick L Altice, MD
Yale University AIDS Program
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2008
First Posted
February 27, 2008
Study Start
August 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
October 17, 2014
Record last verified: 2009-02