Patient Navigation & Counseling for HIV Prevention and Hepatitis C

(M2HepPrEP Trial)

Not currently recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: PrEP, HCV treatment

Disqualifiers: Chronic renal failure, Decompensated cirrhosis, HIV-positive, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best method for providing care in HIV prevention and Hepatitis C treatment for people who inject drugs. It compares two approaches: one involves on-site care with additional support for adhering to the treatment plan (Adherence Counseling), and the other refers patients to off-site specialists with assistance in navigating the system (ARTAS Adapted Patient Navigation). Participants will receive HIV prevention treatment with PrEP (a daily pill to prevent HIV) and Hepatitis C medication if needed. This trial suits individuals who have used injection drugs in the past six months and are currently using services at a clinic or program that provides clean syringes. As an unphased trial, this study offers a unique opportunity to improve care strategies for those who inject drugs.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently on PrEP or Hepatitis C treatment. It seems you may need to stop these specific treatments to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adherence counseling and patient navigation are generally manageable for most people. In one study, about 74% of individuals with hepatitis C and 76% of those with HIV adhered to their treatment plans, indicating that most can follow their treatments without major issues. Another study found that 92% of patients in a shelter-based program adhered to their hepatitis C treatment, demonstrating that supportive care aids in maintaining treatment routines.

Patient navigation, where a guide assists individuals through the healthcare system, has successfully connected people to necessary care. This method has effectively increased healthcare involvement without causing significant side effects.

The treatments in this trial, such as PrEP (Truvada) and hepatitis C treatment (Epclusa), have already received FDA approval for other uses. This approval indicates that these medications have undergone safety testing for other conditions, providing additional reassurance about their safety. While all treatments can have side effects, studies suggest that the methods used here are generally safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance HIV prevention and Hepatitis C care, particularly for people who inject drugs. The trial investigates two approaches: on-site integrated care with adherence counseling and off-site referral with patient navigation. The on-site approach offers comprehensive, integrated health services, including addiction and mental health support, directly at the recruitment clinic, which could improve adherence to HIV and Hepatitis C treatments like Truvada® and Epclusa®. Meanwhile, the off-site approach uses patient navigation to ensure individuals receive timely access to these treatments, even if cost or availability are barriers. By comparing these methods, researchers hope to identify effective strategies to improve care accessibility and outcomes for vulnerable populations.

What evidence suggests that this trial's treatments could be effective for HIV prevention and Hepatitis C?

Research has shown that counseling to help people adhere to their treatment plans can lead to high success rates in curing Hepatitis C (HCV). One study found that individuals who followed at least half of their treatment plan achieved a 99% cure rate. In this trial, participants in the on-site integrated care arm will receive adherence counseling to support their treatment. Meanwhile, the off-site referral arm will use the ARTAS Adapted Patient Navigation program, which has effectively connected people to necessary care. This approach has facilitated timely treatment for both HIV and HCV. These strategies hold promise for managing and treating HCV and preventing HIV in people who inject drugs. ^{1 2 4 6 7}

Who Is on the Research Team?

Julie Bruneau, M.D.

Principal Investigator

Université de Montréal

Lisa R Metsch, Ph.D

Principal Investigator

Columbia University

Daniel Feaster, Ph.D

Principal Investigator

University of Miami

Valérie Martel-Laferrière, MD

Principal Investigator

Université de Montréal

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-64 who inject drugs, are HIV negative, and can commit to an 18-month follow-up. They must live nearby, consent to the study's terms, use contraception if applicable, speak English or French depending on location, and be clients at opioid therapy clinics or syringe programs. Exclusions include severe medical or mental conditions that affect safe participation or informed consent ability.

Inclusion Criteria

HIV negative

Complete a medical release form

I am currently getting help at a clinic for opioid use or a needle exchange program.

Exclusion Criteria

I am allergic or cannot take one of the study's drugs.

I am HIV-positive or have symptoms of an acute HIV infection.

Disabling medical conditions as assessed by medical history, physical exam, vital signs, and/or laboratory assessments that preclude safe participation in the study or ability to provide fully informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either on-site integrated care with adherence counseling or off-site referral to specialized care with patient navigation for PrEP and, if necessary, HCV treatment.

6 months

Regular visits as per treatment arm requirements

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HCV cure and PrEP adherence.

6 months

Visits up to 12 months post-randomization

Long-term Follow-up

Participants are monitored for long-term outcomes such as behavioral disinhibition, STI or HIV incidence, and long-term PrEP adherence.

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Adherence Counseling
• ARTAS Adapted Patient Navigation

Trial Overview

The study aims to find the best way to deliver PrEP for HIV prevention and Hepatitis C treatment among people who inject drugs. Participants will either receive integrated care onsite or be referred offsite for specialized care. The effectiveness of these two strategies will be compared.

How Is the Trial Designed?

Group I: On-site Integrated Care with Adherence Counseling Experimental Treatment 1 Intervention

Participants randomized to the on-site integrated care with adherence counselling arm will be prescribed pre-exposure prophylaxis (PrEP) (Truvada®) and, if indicated, Hepatitis C (HCV) treatment (Epclusa®) at the OAT clinic or SAP from which they were recruited. In addition to PrEP and, if indicated, HCV care, participants in the on-site integrated care arm will receive any required health care services as per local standard of care. Addiction treatment, OAT, and mental health services will be provided, if necessary and available. Participants recruited at syringe access programs (SAP) will be offered addiction counseling and treatment, including OAT when in the integrated care arm in addition to site standard of care.

Group II: Off-site Referral to Specialized Care with Patient Navigation Experimental Treatment 1 Intervention

Participants randomized to the off-site referral to specialized care and patient navigation group will be linked to primary care for PrEP and, if necessary, HCV treatment by a patient navigator. Given the replicated success of the AntiRetroviral Treatment Access Study (ARTAS) intervention regarding linking HIV-infected individuals to HIV primary care, we adapted ARTAS to facilitate people who inject drugs linkage with PrEP and, if necessary, HCV treatment services. Participants in the off-site care arm will be prescribed PrEP and, if necessary, HCV treatment by their off-site physician. All necessary care will also be provided to participants by their off-site physician. Off-site physicians will be notified that if their patients are placed on a waiting list, unable to afford, or are otherwise unable to immediately access PrEP or HCV treatment, Truvada® and Epclusa® are available to participants of the M2HepPrEP study immediately and free of charge.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Université de Sherbrooke

Collaborator

Trials

317

Recruited

79,300+

Simon Fraser University

Collaborator

Trials

59

Recruited

12,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

Published Research Related to This Trial

The HIV-specific patient navigation program in Wisconsin aimed to improve care engagement and viral suppression among individuals at risk for poor health outcomes, particularly those out of care or with persistent viremia.

Over a nine-month period, patient navigators helped identify and address barriers to care, which is crucial since these individuals account for two-thirds of new HIV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Patient Navigation Program to Improve Engagement in HIV Medical Care and Viral Suppression: A Demonstration Project Protocol. Schumann, CL., Westergaard, RP., Meier, AE., et al.[2022]

The Check Hep C program successfully enrolled 388 participants, with 33% initiating treatment for Hepatitis C, and 91% of those who started treatment achieving sustained virologic response (SVR), indicating high cure rates.

Participants who received on-site clinical care were more likely to start treatment compared to those linked to off-site care, highlighting the importance of accessible healthcare services in improving treatment initiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Care to Cure: Demonstrating a Model of Clinical Patient Navigation for Hepatitis C Care and Treatment in High-Need Patients. Ford, MM., Johnson, N., Desai, P., et al.[2022]

A systematic review of 39 studies found that various intervention strategies, including patient navigation and psychosocial support, significantly improve re-engagement in HIV care (odds ratio of 1.79), retention in care (odds ratio of 2.01), and viral suppression (odds ratio of 2.50) among people with HIV who are out of care.

While most strategies showed effectiveness across all outcomes, the 'data-to-care' approach specifically improved re-engagement and retention but lacked sufficient evidence for enhancing viral suppression, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to improve HIV care outcomes for people with HIV who are out of care. Higa, DH., Crepaz, N., Mullins, MM., et al.[2023]

Patient navigation is essential for linking individuals to HIV pre-exposure prophylaxis (PrEP) and re-engaging them in HIV care, as highlighted by a study involving 20 agency staff interviews and 300 patient surveys in Chicago.

Key navigation activities included screening for social determinants of health and providing guidance and referrals, although barriers such as limited staff and clinic capacity were noted, emphasizing the need for adequate resources to support these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of patient navigation in Chicago: Insights on addressing the social determinants of health and integrating HIV prevention and care services. Greene, GJ., Reidy, E., Felt, D., et al.[2022]

The educational and counseling intervention improved adherence to antiretroviral therapy (ARV) in 84% of treatment-naive patients and 93% of patients receiving reinforcement, indicating high effectiveness in preventing virological failure.

The intervention was less effective for patients from outside Europe, suggesting that cultural or social factors may influence adherence to ARV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adherence intervention for HIV-infected patients receiving antiretroviral treatment. Implementation and initial assessment]. Berki-Benhaddad, Z., Ecobichon, JL., Mentré, F., et al.[2019]

A patient navigation program significantly improved linkage to hepatitis C virus (HCV) care and treatment initiation among 1353 socioeconomically disadvantaged patients, with odds ratios of 3.7 and 3.2 respectively within 6 months.

Despite the increased access to care, the patient navigation intervention did not lead to a significant difference in sustained virologic response rates between the navigation and usual care groups, indicating that while access improved, treatment effectiveness remained similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation Increases Linkage to Care and Receipt of Direct-acting Antiviral Therapy in Patients with Hepatitis C. Strebe, J., Rich, NE., Wang, L., 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]

Citations

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Using data from a randomized trial, we evaluated the cost of HCV care facilitation that supports moving along the continuum of care for ...

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The CTN-0049 randomized clinical trial (RCT) demonstrated short-term efficacy of a 6-month patient navigation plus financial incentives approach in increasing ...

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This is a 5-year hybrid type 1 effectiveness-implementation randomized controlled trial that compares two models (Patient Navigation [PN] or ...

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Results from a peer-based digital systems navigation ...

We described baseline characteristics and compared study outcomes (HIV prevention and care) and other behaviors at pre- and post-intervention ( ...