Integrated HIV Prevention and HCV Care for PWID

NCT03981445 | Active Not Recruiting DMC

• 2 other identifiers: AAAR5478R01DA045713
• Study Type: interventional
• Target: 446
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

HIV Prevention; HCV; Opioid Use; Intravenous Drug Usage

Keywords

PrEP; HCV Treatment; Injection Drug Use

Outcome Measures

Primary Outcomes (2)

• Sustained PrEP adherence

  Average proportion of Dried Blood Spots (DBS) with detectable levels of Tenofovir at 6 months

  6 months post randomization

• HCV cure among HCV positive strata

  HCV cure among the HCV positive strata will be compared between both treatment arms at 12 months post randomization. HCV cure is defined as initiating HCV treatment within six (6) months of being randomized and achieving sustained viral response 12 weeks (SVR-12) post-treatment completion. HCV treatment initiation will be measured using self-report and by assessing medical/drug dispensation records. SVR-12 will be measured by testing HCV-RNA negative 12 weeks after end of HCV treatment. If a participant initiates treatment within six (6) months of randomization but does not achieve SVR-12, they will not be counted as a success. Likewise, if a participant who is randomized as HCV positive achieves SVR-12 but did not initiate treatment within 6-months of randomization, they will not be counted as a success.

  6-months post treatment initiation

Secondary Outcomes (5)

• Long-term sustained PrEP Adherence

  Up to 12 months

• Behavioral disinhibition

  Up to 12 months

• STI or HIV incidence

  Up to 12 months

• HCV Incidence

  Up to 12 months

• PrEP Initiation/Uptake

  Up to 12 months

Study Arms (2)

On-site Integrated Care with Adherence Counseling

EXPERIMENTAL

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.

Behavioral: Adherence Counseling

Off-site Referral to Specialized Care with Patient Navigation

EXPERIMENTAL

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.

Behavioral: ARTAS Adapted Patient Navigation

Interventions

ARTAS Adapted Patient Navigation BEHAVIORAL

Patient navigation will provided by trained patient navigators to participants randomized to the off-site referral to specialized care arm. Patient Navigators will actively coordinate and link participants to available clinics and community resources by scheduling appointments, arranging transportation, and assisting the participant with completing any paperwork that a clinic or service agent may require. The intervention will include up to five, 30-45 minute face-to-face meetings between the patient navigator and participant. These meetings will be tailored around each participant's needs. Additionally, the patient navigator assists the participant in identifying and utilizing informal and formal sources of support to move along the PrEP and/or HCV care continuum.The patient navigator will help the participant inform off-site physicians of the trial and of the availability of PrEP and HCV medication, should the physician and patient decide to initiate one or both treatments.

Off-site Referral to Specialized Care with Patient Navigation

Adherence Counseling BEHAVIORAL

Counseling for PrEP initiation and adherence and, if necessary, HCV treatment will be provided by the clinical counseling staff of the on-site integrated care arm. Adherence counseling will include, but not be limited to, the indications, advantages, and disadvantages (e.g. side effects) of PrEP and HCV treatment in order to help the participant with his/her decision. The counselor will provide any necessary information to the participants and help them to address health and social needs. If required, the counselor will help the patient and physician with insurance-related issues. Adherence counselling will be carried out in a motivational style. The intervention will include five 30-45 minute face-to-face meetings with the participant and the adherence counselor over 6 months.

On-site Integrated Care with Adherence Counseling

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals must meet the following criteria to be eligible to participate in the RCT:
• be 18-64 years of age
• report injection drug use in the past 6-months
• be HIV negative
• provide informed consent
• complete a medical release form
• report living in the vicinity and being able to return for follow-up over 18-months
• be willing to use a medically acceptable form of contraception throughout the study duration (for women of childbearing potential)
• be able to communicate in English or French (site dependent)
• be receiving services at an opioid agonist therapy clinic or a syringe access program
• Individuals must meet the following criteria to be eligible to participate in the qualitative interview:
• have completed the first 6 months of RCT follow up (RCT participant interviews);
• provide informed consent;
• have contributed to assessments/interviews, intervention and/or treatment follow-ups (staff interviews).

You may not qualify if:

• Individuals will be excluded from the RCT if they:
• have any disabling medical conditions as assessed by medical history, physical exam, vital signs, and/or laboratory assessments that in the opinion of the study physician preclude safe participation in the study or ability to provide fully informed consent.
• have any disabling mental conditions as assessed by medical history and clinical assessment that in the opinion of the study physician precludes safe participation in the study or ability to provide fully informed consent.
• have chronic renal failure
• have or have history of decompensated cirrhosis
• are HIV-positive or have symptoms of an acute HIV infection
• are pregnant (verified via pregnancy test), are planning to be pregnant during the course of the study, or breastfeeding
• have an allergy or contraindication to one of the study medications
• have prior HCV treatment failure with direct-acting antiviral (DAA) regimens (Except those who were treated, cured the virus, but were re-infected with a new virus)
• are currently on PrEP and/or HCV treatment.
• are currently in prison, in any inpatient overnight facility as required by court of law or have a pending legal action, which may prevent an individual from completing the study.

Sponsors & Collaborators

• Columbia University: lead
• Université de Montréal: collaborator
• University of Miami: collaborator
• Weill Medical College of Cornell University: collaborator
• Université de Sherbrooke: collaborator
• Simon Fraser University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (3)

Miami

Miami, Florida, 33136, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Montreal

Montreal, Quebec, Canada

Location

Related Publications (1)

• Martel-Laferriere V, Feaster DJ, Metsch LR, Schackman BR, Loignon C, Nosyk B, Tookes H, Behrends CN, Arruda N, Adigun O, Goyer ME, Kolber MA, Mary JF, Rodriguez AE, Yanez IG, Pan Y, Khemiri R, Gooden L, Sako A, Bruneau J. M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID. Trials. 2022 Apr 23;23(1):341. doi: 10.1186/s13063-022-06085-3.

  PMID: 35461260 BACKGROUND

Related Links

• Related Info

Study Officials

• Lisa R Metsch, Ph.D

  Columbia University

  PRINCIPAL INVESTIGATOR

• Julie Bruneau, M.D.

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Daniel Feaster, Ph.D

  University of Miami

  PRINCIPAL INVESTIGATOR

• Valérie Martel-Laferrière, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This trial is an open-label, un-blinded study. Given the pragmatic nature of the trial, participants, providers and research staff will not be blinded. Research and clinical staff will be blinded to the randomization procedure to prevent predictions about participant assignment.Research and clinical staff will initially be blinded to arm assignment to avoid bias, but after baseline the research and clinical staff will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of General Studies

Model Details: This trial is an open-label, multi-site, multi-center, randomized, controlled,superiority trial with two parallel treatment arms. The study is a type-1 hybrid effectiveness implementation study. Participants will be randomized to the on-site integrated care with adherence counselling treatment or the off-site referral to specialized care group with patient navigation in a 1:1 ratio using a permuted-block randomization scheme.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: November 14, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (2); CA (1)