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

Columbia University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Substance-related Disorders

Treatments: Behavioral: On-site bundled rapid HIV/HCV testing; Behavioral: Standard of care (SOC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02355080

AAAN5869

R34DA038530 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

On-site bundled rapid HIV/HCV testing

Experimental group

Description:

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.

Treatment:

Behavioral: On-site bundled rapid HIV/HCV testing

Standard of care (SOC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of care (SOC)