Behavioral Science Aspects of Rapid Test Acceptance | NCT01317784

Studies
Behavioral Science Aspects of Rapid Test Acceptance

NCT01317784

Sponsor

California State University, Long Beach

Status

Completed

Last Update Posted

Jul 29, 2015Estimated

Enrollment

1,200Actual

Phase

Not Applicable

Conditions

HIV
Hepatitis C
Hepatitis B
Syphilis

Interventions

Rapid tests for HIV, HCV, HBV, and syphilis
HIV/HCV
HIV/syphilis
HIV only

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA030234	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jun 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Mar 16, 2011

First Submission Date that Met QC Criteria

Mar 16, 2011

First Posted Date

Mar 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2015

Last Update Posted Date

Jul 29, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dennis G. Fisher, Professor and Director, California State University, Long BeachPrincipal Investigator

Lead Sponsor

California State University, Long BeachOTHER

Collaborators

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This application addresses "Studies to improve access and utilization of HIV counseling and testing" for "HIV/AIDS and AIDS-related co-infections" such as "hepatitis C virus (HCV), other sexually transmitted infections (STIs)" that are part of PA-07-307 Drug Abuse Aspects of HIV/AIDS. The only rapid tests that are approved for use in the US currently are for HIV infection. Tests for other conditions such as hepatitis C (HCV) and syphilis are in use in other countries. In response to an Opportunity that the CDC published in the Federal Register, there are now candidate rapid test kits for HCV and syphilis available for experimental use in the US. Different combinations of rapid and standard tests will be offered to participants in a four-arm trial to assess which tests are accepted by the participants. Only a minority of clients at CBRS who have been offered the rapid test for HIV have accepted it. Those who chose rapid HIV tests were more likely to be male, educated, gay, young and White. They were less likely to be Black, or injection drug users. The proposed study has the potential to have a significant impact upon screening for HIV, syphilis, and HCV. Rapid tests have the potential to increase the receipt of test results, particularly among groups that are less likely to return for their results using traditional testing. The candidate tests are designed for Point of Care (either oral fluid and/or whole blood), and thus will require real-time testing, so the trial will be able to evaluate both the accuracy of the tests in settings of intended use and their acceptability to potential clients in real-world situations.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rapid tests for HIV, HCV, HBV, and syphilis	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Test choice profile	Which tests do participants choose to receive when bundled in different combinations?	one day (day one of study)

Secondary Outcomes

Measure	Description	Time Frame
Return for standard test results	Is there a different return for test results rate for the different arms of the study?	one week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dennis G Fisher, Ph.D.	California State University, Long Beach	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Behavioral Research and Services		Long Beach	California	90813	United States

Type	Date	Date Unknown
Release	Feb 25, 2016
Reset	Mar 24, 2016
Release	Jul 25, 2018
Reset	Aug 21, 2018

Submission Tracking

Estimated Results First Submitted Date

Feb 25, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 25, 2016			Mar 24, 2016
Jul 25, 2018

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D006509	Hepatitis B
D013587	Syphilis

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided