Substance-related Disorders Clinical Trial
— iKnow2 ProjectOfficial title:
A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results
Verified date | February 2018 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 134 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Acacia Network/Promesa | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Beth Israel Medical Center, National Institute on Drug Abuse (NIDA), New York University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-Report Receipt of HIV and Hepatitis C Test Results | 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. | One month post-randomization | |
Secondary | 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.) | 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. | One month post-randomization | |
Secondary | Sexual risk behaviors (Counts of unprotected vaginal and anal sex acts in the past 3 months with any sex partner.) | Counts of unprotected vaginal and anal sex acts in the past 3 months with any sex partner. | One month post-randomization | |
Secondary | Drug use behaviors (Prevalence of use of any drugs in the past 3 months; and unsafe injection practices.) | Prevalence of use of any drugs in the past 3 months; and unsafe injection practices. | One month post-randomization |
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