HIV/HCV Testing for Substance Use Disorder

Overseen By Terri Liguori, M.Ed., Ed.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: High HIV/HCV testing rate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

418 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of coaching interventions to improve HIV and Hepatitis C (HCV) testing among patients in opioid treatment programs (OTPs). The goal is to determine if these coaching methods can increase the number of patients tested and linked to care for HIV and HCV. Participants should be involved in substance use disorder treatment at facilities not already testing more than 50% of their patients for HIV or HCV. The trial seeks to identify which coaching method most effectively increases testing and connects patients to necessary care. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance testing and care for HIV and HCV in their communities.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these practice coaching interventions are safe for improving HIV/HCV testing in opioid treatment programs?

Research has shown that coaching programs can significantly increase HIV and HCV testing in substance use programs. These programs aim to enhance testing and connect patients to care. While specific safety details for these coaching methods are not provided, they are generally safe and non-invasive ways to improve healthcare services. As this study is in the "Not Applicable" phase, it focuses on refining methods and systems rather than testing drugs or treatments directly on people. Consequently, the interventions are likely well-tolerated and aim to improve current testing procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they aim to improve how HIV and HCV testing is integrated into treatment programs for people with substance use disorders. Unlike standard testing practices, these coaching interventions focus on training healthcare providers to effectively implement and sustain on-site testing, ensuring patients are quickly linked to necessary care. The dual HIV and HCV Testing Practice Coaching Intervention is particularly promising as it supports combined testing processes, potentially streamlining patient care and improving health outcomes for those in opioid treatment programs (OTPs). By enhancing the delivery and uptake of testing, these interventions could significantly improve early detection and treatment of HIV and HCV in a high-risk population.

What evidence suggests that this trial's interventions could be effective for improving HIV and HCV testing in substance use disorder treatment programs?

Research has shown that coaching programs can effectively increase HIV and HCV testing rates among patients in opioid treatment programs. In this trial, participants may join different intervention groups. The HIV and HCV Testing Practice Coaching Intervention, one study arm, results in more patients being tested for both HIV and HCV compared to the arm focusing solely on HIV testing. These programs aim to simplify testing and ensure patients continue their care. Overall, early evidence supports that these interventions can improve testing and care for people with substance use disorders. ^{1 2 3 6 7}

Who Is on the Research Team?

Jemima Frimpong, PhD

Principal Investigator

New York University Abu Dhabi

Lisa Metsch, PhD

Principal Investigator

Columbia University

Lauren Gooden, PhD

Principal Investigator

Columbia University

Daniel Feaster, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for opioid treatment programs (OTPs) that see at least 150 patients a year and can collect data on HIV/HCV testing and care. OTPs must be willing to share patient demographics, test reimbursement details, and have staff agree to participate in surveys and coaching.

Inclusion Criteria

My treatment center can share my demographic and testing data, and information on HIV/HCV test costs and results.

Eligible sites must be capable and willing to prospectively collect data on the number of patients who a) are offered any HIV and/or HCV tests; b) completed these tests; c) are referred to care/evaluation (and type of referral) if positive; and d) are linked to care/evaluation within 30 days of diagnosis

Eligible sites must have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study

Exclusion Criteria

Sites will be excluded if over 50% of patients served in the prior 6 months were HIV or HCV tested

Sites will be excluded if they are terminated via PI decision/discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention/Control Period

Implementation of HIV testing interventions or control condition

6 months

Regular site visits for coaching and data collection

Initial Impact Period

Evaluation of the initial impact of interventions on HIV testing rates

6 months

Data collection visits

Sustained Impact Period

Assessment of sustained impact of interventions on HIV testing rates

6 months

Data collection visits

Follow-up

Participants are monitored for long-term outcomes and cost-effectiveness

6 months

What Are the Treatments Tested in This Trial?

Interventions

• HIV and HCV Testing Practice Coaching Intervention
• HIV Testing Practice Coaching Intervention
• Information Control

Trial Overview The study tests two 'practice coaching' interventions aimed at improving HIV and HCV testing rates in OTPs. One focuses solely on HIV, while the other addresses both HIV/HCV. Their effectiveness will be compared with a control group receiving only information.

How Is the Trial Designed?

Group I: Information Control Group Experimental Treatment 1 Intervention

The administrators of OTPs assigned to the control condition will receive a website link to and hard copy of the NIDA/SAMHSA Blending Initiative product for HIV rapid testing.

Group II: HIV and HCV Testing Practice Coaching Intervention Group Experimental Treatment 1 Intervention

The HIV and HCV Testing Practice Coaching (PC) Intervention will leverage the HIV PC intervention and follow the same interventional steps described above, and, in addition, provide information and training to support joint HIV/HCV testing and linkage to care among OTP patients.

Group III: HIV Testing Practice Coaching Intervention Group Experimental Treatment 1 Intervention

The HIV Testing Practice Coaching (PC) Intervention is designed to improve the provision and sustained implementation of on-site HIV testing and linkage to care among OTP patients.

HIV and HCV Testing Practice Coaching Intervention is already approved in United States for the following indications:

Approved in United States as HIV Testing for:

• HIV diagnosis and linkage to care in opioid treatment programs

Approved in United States as HCV Testing for:

• HCV diagnosis and linkage to care in opioid treatment programs

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

New York University Abu Dhabi

Collaborator

Trials

1

Recruited

50+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Aspire Health Partners

Collaborator

Trials

1

Recruited

50+

Research Foundation for Mental Hygiene, Inc.

Collaborator

Trials

68

Recruited

21,100+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

San Francisco Department of Public Health

Collaborator

Trials

38

Recruited

36,000+

Published Research Related to This Trial

A hepatitis C virus (HCV) testing and linkage-to-care program in Durham, North Carolina, successfully tested 2,004 individuals, identifying 326 (16.3%) as HCV antibody positive, with 241 (12.0%) having detectable HCV RNA.

Of those with chronic HCV infection, 51.0% were successfully linked to care, demonstrating that local health departments can effectively implement HCV services by utilizing existing community resources and support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efforts at the Frontlines: Implementing a Hepatitis C Testing and Linkage-to-Care Program at the Local Public Health Level. Seña, AC., Willis, SJ., Hilton, A., et al.[2023]

Only 18% of Florida Medicaid beneficiaries with substance use disorders were tested for hepatitis C virus, and among those tested, only 8% were diagnosed with the virus, highlighting a significant gap in testing and diagnosis.

Despite low testing rates, once diagnosed, 96% of patients who initiated hepatitis C treatments completed them, indicating that treatment adherence is high among those who receive a diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cascade of Hepatitis C Virus Care Among Patients With Substance Use Disorders. Jiang, X., Parker, RL., Vouri, SM., et al.[2022]

A study involving 51 opioid treatment programs is testing two practice coaching interventions to improve on-site HIV and HCV testing, which is crucial for individuals with substance use disorders who are at high risk for HIV.

The research aims to enhance the implementation and sustainability of testing practices, potentially leading to better health outcomes and reduced rates of HIV and HCV infections among this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs. Frimpong, JA., Parish, C., Feaster, DJ., et al.[2023]

A quality improvement initiative at two substance use disorder clinics in Connecticut significantly increased HIV testing rates from 13% to 90% and HCV testing rates from 4% to 90% over a two-year period, demonstrating the effectiveness of targeted strategies in enhancing testing.

The study identified key best practices, such as formal policies, streamlined logistics, and staff education, which facilitated improved testing and referral rates for HIV and HCV, crucial for better management of these co-occurring infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving HIV and HCV Testing in Substance Use Disorder Programs (SUDs) That Provide Medications for Opiate Use Disorder (MOUD): Role of Addressing Barriers and Implementing Universal and Site-Specific Approaches. Brooks, R., Wegener, M., Freeman, B., et al.[2023]

Co-infection with HIV and hepatitis C virus (HCV) significantly increases the risk of severe liver disease, highlighting the urgent need for effective care strategies for this population.

The Care2Cure study is testing a nurse case management intervention aimed at improving access to HCV care for 70 adults co-infected with HIV, with the goal of enhancing linkage to care and reducing the time to treatment initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care2Cure: A randomized controlled trial protocol for evaluating nurse case management to improve the hepatitis C care continuum within HIV primary care. Starbird, LE., Han, HR., Sulkowski, MS., et al.[2020]

Among 4364 HCV-infected patients studied, 76.8% had been tested for HIV, indicating a significant level of testing, but 14.8% had never been tested, highlighting missed opportunities for early diagnosis.

Factors such as injection drug use and sexual behavior were strongly associated with both HIV testing and seropositivity, suggesting that targeted public health strategies are needed to improve testing rates in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National multicenter study of HIV testing and HIV seropositivity in patients with chronic hepatitis C virus infection. Bini, EJ., Currie, SL., Shen, H., et al.[2022]

The integration of the OraQuick HCV rapid antibody test at the Denver Metro Health Clinic was successful, allowing for quick testing and results for clients at risk of hepatitis C, which could enhance early identification of infections.

While clients appreciated the ease of the test, challenges such as loss to follow-up and limited knowledge about hepatitis C among clients were identified as barriers to effective care integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Integration of Hepatitis C Virus Point-of-Care Tests into the Denver Metro Health Clinic. Jewett, A., Al-Tayyib, AA., Ginnett, L., et al.[2021]

A project in Philadelphia tested 4,514 patients for hepatitis C virus (HCV) in community health centers, revealing a 13.2% positivity rate for HCV antibodies, with 70.9% of those confirmed to have chronic HCV infection.

Innovative strategies, such as improved electronic medical records and a linkage-to-care coordinator, significantly enhanced HCV testing and referral rates, demonstrating the effectiveness of community health centers in addressing HCV among high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and Linkage to Care of HCV-Infected Persons in Five Health Centers - Philadelphia, Pennsylvania, 2012-2014. Coyle, C., Viner, K., Hughes, E., et al.[2018]

Nurse case management (NCM) significantly improved linkage to hepatitis C (HCV) care for adults co-infected with HIV, with 47% of NCM participants attending an HCV appointment within 60 days compared to only 25% in the usual care group.

Despite better linkage to care, the initiation of direct-acting antivirals (DAAs) was low in both groups, indicating that while NCM helps connect patients to care, additional strategies are needed to ensure they start treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse case management to improve the hepatitis C care continuum in HIV co-infection: Results of a randomized controlled trial. Starbird, LE., Budhathoki, C., Han, HR., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10521543/

A study protocol for Project I-Test: a cluster randomized ... This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07602-8

A study protocol for Project I-Test: a cluster randomized ... - Trials This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03135886?cond=HCV%20OR%20%22hepatitis%20C%22&aggFilters=funderType:nih%20fed,status:rec&rank=7

Project I Test: Implementing HIV Testing in Opioid ... This study will test two active evidence-based "practice coaching" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07088770

TechMPower: Advancing HIV/SUD Care and Service Delivery for ... The goal of this clinical study in one NY county is to pilot and refine implementation strategies aimed at improving delivery and uptake of evidence-based ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03135886/project-i-test-implementing-hiv-testing-in-opioid-treatment-programs?activelyRecruiting=false&page=248&id=219&slug=addictions

Implementing HIV Testing in Opioid Treatment Programs This study will test two active evidence-based "practice coaching" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained ...

6. withpower.com withpower.com/trial/phase-hepatitis-5-2017-233a4

HIV/HCV Testing for Substance Use Disorder Research shows that practice coaching interventions can significantly increase HIV and HCV testing rates in substance use disorder programs, as seen in a study ...

7. researchgate.net researchgate.net/publication/374193408_A_study_protocol_for_Project_I-Test_a_cluster_randomized_controlled_trial_of_a_practice_coaching_intervention_to_increase_HIV_testing_in_substance_use_treatment_programs

a cluster randomized controlled trial of a practice coaching ... This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals ...