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Active, Not Recruiting

NCT Number: NCT03981445

Integrated HIV Prevention and HCV Care for PWID

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Prevention HCV Intravenous Drug Usage Opioid Use

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal, Quebec, Canada

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About this study

The first strategy, the on-site integrated care model, provides opioid agonist therapy (OAT) clinics and harm reduction sites/syringe access programs (SAP) with the tools to offer HIV prevention and HCV treatment on-site. The second strategy, the off-site referrals to specialized care model, connects people who are at risk for contracting HIV with patient navigators who help them access available HIV prevention care and, if necessary, HCV treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Sustained PrEP adherence

    Time frame: 6 months post randomization

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

  2. HCV cure among HCV positive strata

    Time frame: 6-months post treatment initiation

    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.

Secondary outcomes

  1. Long-term sustained PrEP Adherence

    Time frame: Up to 12 months

    Proportion of participants who self-report PrEP use and achieve detectable levels of tenofovir as measured by DBS testing at 6 months and 12 months post randomization.

  2. Behavioral disinhibition

    Time frame: Up to 12 months

    Proportion of participants who increase sexual or injection risk behaviors as measured by self- report questionnaires administered at each research visit.

  3. STI or HIV incidence

    Time frame: Up to 12 months

    Sexually Transmitted Infections (STI) incidence will be defined as a positive test result for Neisseria gonorrhoeae, Chlamydia trachomatis, HIV or syphilis in participants who formerly tested negative for the STI(s).

  4. HCV Incidence

    Time frame: Up to 12 months

    HCV status will be determined by HCV-Ab testing, and if positive, HCV-RNA testing. New incidence of HCV will be defined as an HCV-Ab positive test results in participants who were HCV-Ab negative at a previous testing visit and HCV-Ab positive/HCV-RNA positive test results in participants who had previously tested HCV-Ab positive/HCV-RNA negative

  5. PrEP Initiation/Uptake

    Time frame: Up to 12 months

    Proportion of participants who initiate PrEP before 6 months post randomization and between 6 to 12 months post randomization. PrEP initiation will be defined as record of dispensation of the first dose of TDF/FTC to a participant.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

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

Registry information

Official study title

A Multi-site Multi-Setting Randomized Controlled Trial (RCT) of Integrated HIV Prevention and HCV Care for People Who Inject Drugs (PWID)

Acronym: M2HepPrEP

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2019
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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