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Completed

NCT Number: NCT02355080

A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Acacia Network/Promesa

New York, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

On-site bundled rapid HIV/HCV testing

Behavioral

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.

Standard of Care (SOC)

Behavioral

Participants will receive the SOC for HIV and HCV testing at the study sites.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Beth Israel Medical Center
  • National Institute on Drug Abuse (NIDA)
  • New York University

Registry information

Acronym: iKnow2 Project

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 4, 2015
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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