Patient Navigation & Counseling for HIV Prevention and Hepatitis C

(M2HepPrEP Trial)

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

446 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Adherence Counseling, ARTAS Adapted Patient Navigation for HIV Prevention and Hepatitis C?

Research shows that patient navigation programs, like Check Hep C, have successfully helped patients start and stick with their treatment, leading to high cure rates for Hepatitis C. Additionally, studies indicate that patient navigation is positively associated with better HIV care outcomes, such as staying in care and taking medication regularly. ^{1 2 3 4 5}

Is patient navigation and counseling for HIV prevention and Hepatitis C safe for humans?

Patient navigation and counseling programs, like Check Hep C, have been used safely to support patients in managing their Hepatitis C treatment, showing high cure rates and no reported safety issues. ^{1 4 6 7 8}

How does the patient navigation and counseling treatment for HIV prevention and Hepatitis C differ from other treatments?

This treatment is unique because it uses patient navigation, which involves personalized guidance and support to help patients access and adhere to care, addressing barriers like social determinants of health. Unlike standard treatments that focus solely on medication, this approach integrates counseling and coordination to improve health outcomes, especially in underserved populations. ^{1 9 10 11 12}

What is the purpose of this trial?

The objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care. Participants will be randomized to one of two treatment arms: on-site integrated care or off-site referral to specialized care.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Is HIV patient navigation associated with HIV care continuum outcomes? [2020]

3. Brazil pubmed.ncbi.nlm.nih.gov

Validation of a counseling guide for adherence to antiretroviral therapy using implementation science. [2020]

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. England pubmed.ncbi.nlm.nih.gov

Strategies to improve HIV care outcomes for people with HIV who are out of care. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Hepatitis C coinfection is independently associated with decreased adherence to antiretroviral therapy in a population-based HIV cohort. [2016]

7. France pubmed.ncbi.nlm.nih.gov

[Adherence intervention for HIV-infected patients receiving antiretroviral treatment. Implementation and initial assessment]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Positive impact of hepatitis C virus (HCV) treatment on antiretroviral treatment adherence in human immunodeficiency virus-HCV coinfected patients: one more argument for expanded access to HCV treatment for injecting drug users. [2015]

9. England 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. [2022]

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

Patient Navigation Increases Linkage to Care and Receipt of Direct-acting Antiviral Therapy in Patients with Hepatitis C. [2023]

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

Developing a Patient Navigation Program to Improve Engagement in HIV Medical Care and Viral Suppression: A Demonstration Project Protocol. [2022]

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

Implementation and Operational Research: The Navigation Program: An Intervention to Reengage Lost Patients at 7 HIV Clinics in Los Angeles County, 2012-2014. [2020]