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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|United States, New York|
|New York, New York, United States|
|Principal Investigator:||Jemima A. Frimpong, PhD, MPH||Columbia University|