Substance-related Disorders
Conditions
Keywords
HIV, HCV
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.
Interventions
BEHAVIORALOn-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.
BEHAVIORALStandard of care (SOC)
Participants will receive the SOC for HIV and HCV testing at the study sites.
Sponsors
New York University
Beth Israel Medical Center
National Institute on Drug Abuse (NIDA)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Report Receipt of HIV and Hepatitis C Test Results | 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
| Measure | Time frame | Description |
|---|---|---|
| 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.) | 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.) | 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.) | One month post-randomization | Prevalence of use of any drugs in the past 3 months; and unsafe injection practices. |
Countries
United States
Outcome results
None listed