HIV/HCV Testing for Substance Use Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Jemima Frimpong, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Disqualifiers: High HIV/HCV testing rate, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will test two active evidence-based "practice coaching" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site 1) HIV testing and linkage to care and 2) HIV/Hepatitis C virus (HCV) testing and linkage to care among patients seeking/receiving substance use disorder treatment. Aims are: Aim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIV/HCV intervention on HIV testing. Aim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care. Aim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition. Primary Hypothesis: 1. The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the "initial impact" period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Primary) and during the "sustained impact" period, 13-18 months post-randomization or T4 (Secondary). 2. The HIV/HCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Secondary) and during the "sustained impact" period, 13-18 months post-randomization or T4 (Secondary).

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 data supports the effectiveness of the treatment for HIV and HCV testing in substance use disorder programs?

Research shows that practice coaching interventions can significantly increase HIV and HCV testing rates in substance use disorder programs, as seen in a study where HIV testing rates increased from 13% to 90% and HCV testing from 4% to 90% in certain clinics. This suggests that structured support and resources can effectively enhance testing and linkage to care. ^{1 2 3 4 5}

Is the HIV/HCV Testing Practice Coaching Intervention safe for humans?

The research articles do not provide specific safety data for the HIV/HCV Testing Practice Coaching Intervention, but they focus on improving testing and care practices, which generally do not pose safety risks to participants. ^{1 2 5 6 7}

What makes the HIV/HCV Testing Practice Coaching Intervention unique compared to other treatments for substance use disorder?

This treatment is unique because it uses practice coaching to integrate HIV and HCV testing into substance use disorder treatment programs, focusing on organizational change to improve testing rates and linkage to care, which is not commonly addressed in standard treatments. ^{1 5 6 8 9}

Research Team

Lisa Metsch, PhD

Principal Investigator

Columbia University

Daniel Feaster, PhD

Principal Investigator

University of Miami

Jemima Frimpong, PhD

Principal Investigator

New York University Abu Dhabi

Lauren Gooden, PhD

Principal Investigator

Columbia University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• HIV and HCV Testing Practice Coaching Intervention (Behavioural Intervention)
• HIV Testing Practice Coaching Intervention (Behavioural Intervention)
• Information Control (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

New York University Abu Dhabi

Collaborator

Trials

1

Recruited

50+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Aspire Health Partners

Collaborator

Trials

1

Recruited

50+

Research Foundation for Mental Hygiene, Inc.

Collaborator

Trials

68

Recruited

21,100+

Dr. Jeffrey Borenstein

Research Foundation for Mental Hygiene, Inc.

Chief Executive Officer since 2012

MD from New York University, undergraduate degree from Harvard University

Dr. John McDaniel

Research Foundation for Mental Hygiene, Inc.

Chief Medical Officer since 2018

MD from Harvard Medical School

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Dr. Alastair Bell

Boston Medical Center

Chief Executive Officer since 2023

MD from University of Oxford, MBA from Harvard Business School

Dr. Ravin Davidoff

Boston Medical Center

Chief Medical Officer since 2008

M.B., B.Ch. from University of Witwatersrand, South Africa

San Francisco Department of Public Health

Collaborator

Trials

38

Recruited

36,000+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Identification and Linkage to Care of HCV-Infected Persons in Five Health Centers - Philadelphia, Pennsylvania, 2012-2014. [2018]

3. England 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. [2021]

4. United States 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. [2020]

5. United States 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Cascade of Hepatitis C Virus Care Among Patients With Substance Use Disorders. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Successful Integration of Hepatitis C Virus Point-of-Care Tests into the Denver Metro Health Clinic. [2021]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

National multicenter study of HIV testing and HIV seropositivity in patients with chronic hepatitis C virus infection. [2022]