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Patient Navigation & Counseling for HIV Prevention and Hepatitis C (M2HepPrEP Trial)

N/A

Waitlist Available

Led By Julie Bruneau, M.D.

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving services at an opioid agonist therapy clinic or a syringe access program

Age between 18-64 years

Must not have

Allergy or contraindication to one of the study medications

HIV-positive or symptoms of an acute HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This triallooks at two different ways to give PrEP & HCV treatment to people who inject drugs to determine which is better. Participants will be randomly assigned to one of two groups.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed in this summary, potential side effects may arise from medications used in PrEP (Pre-exposure Prophylaxis) and HCV (Hepatitis C Virus) treatments which typically include nausea, headache, fatigue, and possible liver-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am currently taking medication to prevent HIV or treat hepatitis C.

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I have long-term kidney problems.

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I have or had severe liver disease with symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hepatitis C

Sustained PrEP adherence

Secondary study objectives

Behavioral disinhibition

HCV Incidence

Long-term sustained PrEP Adherence

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: On-site Integrated Care with Adherence CounselingExperimental Treatment1 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 NavigationExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adherence Counseling

2011

Completed Phase 4

~1310

0 / 7Eligibility criteria met