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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

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE February 4, 2015
Last Update Posted Date February 23, 2018
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
Self-Report Receipt of HIV 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • 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: Three months 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.
  • Sexual risk behaviors (Counts of unprotected vaginal and anal sex acts in the past 3 months with any sex partner.) [ Time Frame: Three months post-randomization ]
    Counts of unprotected vaginal and anal sex acts in the past 3 months with any sex partner.
  • Drug use behaviors (Prevalence of use of any drugs in the past 3 months; and unsafe injection practices.) [ Time Frame: Three months post-randomization ]
    Prevalence of use of any drugs in the past 3 months; and unsafe injection practices.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results
Official Title  ICMJE A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Substance-related Disorders
Intervention  ICMJE
  • 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.
  • Behavioral: Standard of care (SOC)
    Participants will receive the SOC for HIV and HCV testing at the study sites.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: On-site bundled rapid HIV/HCV testing
  • 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.
    Intervention: Behavioral: Standard of care (SOC)
Publications * Frimpong JA, D'Aunno T, Perlman DC, Strauss SM, Mallow A, Hernandez D, Schackman BR, Feaster DJ, Metsch LR. On-site bundled rapid HIV/HCV testing in substance use disorder treatment programs: study protocol for a hybrid design randomized controlled trial. Trials. 2016 Mar 3;17(1):117. doi: 10.1186/s13063-016-1225-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2018)
134
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2015)
191
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02355080
Other Study ID Numbers  ICMJE AAAN5869
R34DA038530 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jemima Frimpong, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • New York University
  • Beth Israel Medical Center
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Jemima A. Frimpong, PhD, MPH Columbia University
PRS Account Columbia University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP