Clinical trial NCT02355080: A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results
Official title: A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Substance-related Disorders
Keywords: HIV
HCV
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: New York University
name: Beth Israel Medical Center
name: National Institute on Drug Abuse (NIDA)
First posted: 2015-02-04
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Self-Report Receipt of HIV and Hepatitis C Test Results
timeFrame: One month post-randomization
Secondary outcomes:
measure: 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.)
timeFrame: One month post-randomization
measure: Sexual risk behaviors (Counts of unprotected vaginal and anal sex acts in the past 3 months with any sex partner.)
timeFrame: One month post-randomization
measure: Drug use behaviors (Prevalence of use of any drugs in the past 3 months; and unsafe injection practices.)
timeFrame: One month post-randomization
Other outcomes:
Locations:
city: New York
country: United States
facility: Acacia Network/Promesa
state: New York
Study officials:
affiliation: Columbia University
name: Jemima A. Frimpong, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frimpong JA, D'Aunno T, Perlman DC, Strauss SM, Mallow A, Hernandez D, Schackman BR, Feaster DJ, Metsch LR. On-site bundled rapid HIV/HCV testing in substance use disorder treatment programs: study protocol for a hybrid design randomized controlled trial. Trials. 2016 Mar 3;17(1):117. doi: 10.1186/s13063-016-1225-4.