Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results (iKnow2 Project)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02355080
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
New York University
Beth Israel Medical Center
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jemima Frimpong, Columbia University

Brief Summary:
This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a HIV and hepatitis C (HCV) testing study. The purpose of this study is to test the efficacy of two HIV/HCV testing strategies on increasing receipt of test results: (1) on-site bundled rapid HIV/HCV testing (i.e., joint offer of HIV and HCV at the point of encounter), and (2) standard of care for HIV and HCV testing.

Condition or disease Intervention/treatment Phase
Substance-related Disorders Behavioral: On-site bundled rapid HIV/HCV testing Behavioral: Standard of care (SOC) Phase 2 Phase 3

Detailed Description:
This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a HIV and hepatitis C (HCV) testing study. The purpose of this study is to test the efficacy of two HIV/HCV testing strategies on increasing receipt of test results: (1) on-site bundled rapid HIV/HCV testing (i.e., joint offer of HIV and HCV at the point of encounter), and (2) standard of care for HIV and HCV testing. Secondary outcomes include linkage to care and HIV and HCV risk behaviors. Participants will complete a baseline assessment to report their demographics, sexual risk behaviors, drug-using risk behaviors, utilization of drug abuse treatment services and will be randomized to one of two groups. At one-month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV or HCV test results. At three months post-randomization, participants will complete a follow-up assessment to assess linkage to care and changes, if any, in their HIV and HCV sexual risk behaviors.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arm Intervention/treatment
Experimental: On-site bundled rapid HIV/HCV testing
Participants will receive the on-site bundled rapid HIV/HCV testing intervention. In the intervention group, all patients will receive an offer to participate in rapid HIV/HCV testing. Those who accept this offer will: receive pre-test information about testing procedures and education, be tested, receive results during the same visit as testing, and be provided post-test counseling and support services by trained test counselors. Patients with a preliminary positive (i.e., reactive) HIV and/or HCV test result(s) will be actively linked immediately to a health care provider for further evaluation and confirmatory HIV and/or HCV RNA testing.
Behavioral: On-site bundled rapid HIV/HCV testing
Participants will be offered bundled on-site rapid HIV and HCV testing with post-test counseling that addresses both sexual and drug use risk reduction, and linkage to care.

Active Comparator: Standard of care (SOC)
Participants will receive the standard of care (SOC) at the study sites. The SOC entails venipuncture whole blood HIV testing + venipuncture whole blood HCV testing. Blood draws are sent to an external laboratory for processing, and patients must return for test results in another visit. Patients may not receive pre-test information or results and post-test counseling, especially if non-reactive or negative test result(s). Reflex testing is not standard practice, therefore some patients may require another visit and blood draw for confirmatory HIV and/or HCV RNA testing. Linkage to care in the SOC is accomplished by referral to a health care provider, either within the participating substance use disorder treatment organization or passive referral to other health facilities.
Behavioral: Standard of care (SOC)
Participants will receive the SOC for HIV and HCV testing at the study sites.




Primary Outcome Measures :
  1. Self-Report Receipt of HIV and Hepatitis C Test Results [ Time Frame: One month post-randomization ]
    The primary outcome is self-reported receipt of HIV/HCV test results. This will be measured at one-month post-randomization for all participants. We acknowledge that there are several potential HIV/HCV testing behaviors that could be evaluated in this study: acceptance of testing, completion of testing, and receipt of testing results, either HIV or HCV. Acceptance of testing measures whether or not a participant would accept the offer of an HIV or HCV test. Completion of testing measures whether or not a participant completes the HIV or HCV test. Receipt of test results refers to whether or not a participant self-reports having received the results of the HIV or HCV test.


Secondary Outcome Measures :
  1. Linkage to care (Proportion of patients who initiated HIV/HCV care before the 3-month follow-up among those whose test results were positive for HIV and/or HCV.) [ Time Frame: One month post-randomization ]
    Proportion of patients who initiated HIV/HCV care before the 3-month follow-up among those whose test results were positive for HIV and/or HCV.

  2. Sexual risk behaviors (Counts of unprotected vaginal and anal sex acts in the past 3 months with any sex partner.) [ Time Frame: One month post-randomization ]
    Counts of unprotected vaginal and anal sex acts in the past 3 months with any sex partner.

  3. Drug use behaviors (Prevalence of use of any drugs in the past 3 months; and unsafe injection practices.) [ Time Frame: One month post-randomization ]
    Prevalence of use of any drugs in the past 3 months; and unsafe injection practices.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Report being HIV and HCV negative, or report not knowing HIV and HCV status
  • Not have received results of an HIV or HCV test initiated within the last 12 months
  • Able and willing to provide informed consent
  • Seeking or currently receiving drug (excluding alcohol only treatment) abuse treatment services at the participating treatment programs
  • At least 18 years old
  • Able to communicate in English
  • Willing to sign a release form that will allow medical record review (to corroborate self-reports of receipt of test results)
  • Able and willing to provide locator information (contact number and address) for follow-up surveys

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355080


Locations
Layout table for location information
United States, New York
Acacia Network/Promesa
New York, New York, United States
Sponsors and Collaborators
Columbia University
New York University
Beth Israel Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Jemima A. Frimpong, PhD, MPH Columbia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jemima Frimpong, Assistant Professor of Health Policy and Management, Columbia University
ClinicalTrials.gov Identifier: NCT02355080     History of Changes
Other Study ID Numbers: AAAN5869
R34DA038530 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jemima Frimpong, Columbia University:
HIV
HCV

Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders