NCT00624247

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
621

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2007

Shorter than P25 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

October 17, 2014

Status Verified

February 1, 2009

Enrollment Period

8 months

First QC Date

February 18, 2008

Last Update Submit

October 16, 2014

Conditions

Keywords

routine HIV testingjailscriminal justice systemsubstance abusemental illnessHIV

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

OTHER

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

Other: routine HIV testing

Following Day

OTHER

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

Other: routine HIV testing

Delayed

OTHER

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

Other: routine HIV testing

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.

DelayedFollowing DayImmediate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (2)

New Haven Community Correctional Center

New Haven, Connecticut, 06511, United States

Location

York Correctional Institution

Niantic, Connecticut, 06357, United States

Location

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: 19946371BACKGROUND
  • 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.

    PMID: 19946370BACKGROUND

MeSH Terms

Conditions

HIV InfectionsSubstance-Related DisordersMental Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced Disorders

Study Officials

  • Frederick L Altice, MD

    Yale University AIDS Program

    PRINCIPAL INVESTIGATOR

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

Locations