NCT01317784

Brief Summary

The relevance of this research to public health is to make it possible to test for hepatitis C and syphilis at point of care so that people will receive their results immediately instead of requiring people to wait for at least a week to get their test results. This research will make rapid tests for HIV available that can detect HIV infection earlier and are more accurate than current tests available in the United States.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started May 2011

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

3.1 years

First QC Date

March 16, 2011

Last Update Submit

July 27, 2015

Conditions

HIVHepatitis CHepatitis BSyphilis

Keywords

diagnosis screeningHIV serodiagnosisHCV antibodiesserologic testsBedside testingdiagnostic test kitssyphilis serodiagnosis

Outcome Measures

Primary Outcomes (1)

  • Test choice profile

    Which tests do participants choose to receive when bundled in different combinations?

    one day (day one of study)

Secondary Outcomes (1)

  • Return for standard test results

    one week

Study Arms (4)

All tests.

EXPERIMENTAL

Choose from all 16 possible tests.

Device: Rapid tests for HIV, HCV, HBV, and syphilis

HIV/HCV

ACTIVE COMPARATOR

Choice of 10 different HIV and hepatitis C tests in the bundle.

Device: HIV/HCV

HIV/Syphilis

ACTIVE COMPARATOR

Choice of 7 different tests for HIV and syphilis.

Device: HIV/syphilis

HIV only

ACTIVE COMPARATOR

Choice of 4 rapid tests for HIV only.

Device: HIV only

Interventions

Rapid tests for HIV, HCV, HBV, and syphilisDEVICE

Choice of 16 different rapid tests. Only 12 manufacturer and names are shown because some are used with both blood and oral fluid. When they are used on both specimens, they are counted as two tests.

Also known as: INSTITM HIV-1 Antibody Test (bioLytical Laboratories, Inc.), Determine HIV-1/2 Ag/Ab Combo (Alere, Inc.), DPP® HIV 1/2 Screen Assay (Chembio, Inc.), OraQuick HCV antibody test (Orasure), DPP® HCV Screen Assay (Chembio, Inc.), DPP® HIV-HCV Screen Assay (Chembio, Inc.), Multiplo Rapid HIV/HCV Antibody Test (MedMira, Inc.), DPP® Syphilis Screen & Confirm Assay (Chembio, Inc.), DPP® HIV-Syphilis Screen Assay (Chembio, Inc.), DPP® HIV-HCV-Syphilis Screen Assay (Chembio, Inc.), Multiplo Rapid HIV/HCV/HBV Antibody Test (MedMira, Inc.)
All tests.
HIV/HCVDEVICE

Choice of 10 different tests for HIV and hepatitis C.

Also known as: INSTITM HIV-1 Antibody Test (bioLytical Laboratories, Inc.), Determine HIV-1/2 Ag/Ab Combo (Alere, Inc.), DPP® HIV 1/2 Screen Assay (Chembio, Inc.), OraQuick HCV antibody test (Orasure), DPP® HCV Screen Assay (Chembio, Inc.), DPP® HIV-HCV Screen Assay (Chembio, Inc.), Multiplo Rapid HIV/HCV Antibody Test (MedMira, Inc.)
HIV/HCV
HIV/syphilisDEVICE

Choice of 7 different tests for HIV and syphilis

Also known as: INSTITM HIV-1 Antibody Test (bioLytical Laboratories, Inc.), Determine HIV-1/2 Ag/Ab Combo (Alere, Inc.), DPP® HIV 1/2 Screen Assay (Chembio, Inc.), DPP® Syphilis Screen & Confirm Assay (Chembio, Inc.), DPP® HIV-Syphilis Screen Assay (Chembio, Inc.)
HIV/Syphilis
HIV onlyDEVICE

Choice of 4 different tests for HIV only.

Also known as: INSTITM HIV-1 Antibody Test (bioLytical Laboratories, Inc.), Determine HIV-1/2 Ag/Ab Combo (Alere, Inc.), DPP® HIV 1/2 Screen Assay (Chembio, Inc.)
HIV only

Eligibility Criteria

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

You may qualify if:

  • Over 17 years old
  • Mentally stable
  • Sober
  • Able to understand English or Spanish
  • At least one good vein for phlebotomy
  • Member of Behavioral Risk Group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Behavioral Research and Services

Long Beach, California, 90813, United States

Location

MeSH Terms

Conditions

Hepatitis CHepatitis BSyphilis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Dennis G Fisher, Ph.D.

    California State University, Long Beach

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

July 29, 2015

Record last verified: 2015-07

Locations

US(1)