A Bundled Rapid HIV/HCV Testing Intervention to Increase Receipt of Test Results

NCT02355080 | Completed Phase 2

• 2 other identifiers: AAAN5869R34DA038530
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-related Disorders

Keywords

HIV; HCV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Sexual risk behaviors (Counts of unprotected vaginal and anal sex acts in the past 3 months with any sex partner.)

  One month post-randomization

• Drug use behaviors (Prevalence of use of any drugs in the past 3 months; and unsafe injection practices.)

  One month post-randomization

Study Arms (2)

On-site bundled rapid HIV/HCV testing

EXPERIMENTAL

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

Standard of care (SOC)

ACTIVE COMPARATOR

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)

Interventions

On-site bundled rapid HIV/HCV testing BEHAVIORAL

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.

On-site bundled rapid HIV/HCV testing

Standard of care (SOC) BEHAVIORAL

Participants will receive the SOC for HIV and HCV testing at the study sites.

Standard of care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• New York University: collaborator
• Beth Israel Medical Center: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Acacia Network/Promesa

New York, New York, United States

Location

Related Publications (1)

• 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.

  PMID: 26936623 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jemima A. Frimpong, PhD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Health Policy and Management

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: April 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)