Clinical Trials

MainTitle

Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP)

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2020 by Lisa Metsch, Columbia University

Sponsor
Columbia University

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

Information provided by (Responsible Party)
Lisa Metsch, Columbia University

ClinicalTrials.gov Identifier
NCT03981445

First received: June 6, 2019
Last updated: March 3, 2020
Last Verified: March 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Prevention
HCV
Opioid Use
Intravenous Drug Usage

Behavioral : ARTAS Adapted Patient Navigation
Behavioral : Adherence Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-site Multi-Setting Randomized Controlled Trial (RCT) of Integrated HIV Prevention and HCV Care for People Who Inject Drugs (PWID)

Further study details as provided by Lisa Metsch, Columbia University:

Primary Outcome Measures

  • Sustained PrEP adherence [ Time Frame: 6-months post treatment initiation ]
    Average proportion of Dried Blood Spots (DBS) with therapeutic levels of Tenofovir at 6 months
  • 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 six (6) months post treatment initiation. 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. 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 Outcome Measures:
  • Long-term sustained PrEP Adherence [ Time Frame: Up to 18 months ]
    Proportion of participants who self-report daily PrEP use and achieve protective levels of tenofovir as measured by DBS testing at 6-months, 12 months and 18 months post-baseline.
  • Behavioral disinhibition [ Time Frame: Up to 18 months ]
    Proportion of participants who increase sexual or injection risk behaviours as measured by self-report questionnaires administered at each research visit.
  • STI Incidence [ Time Frame: Up to 18 months ]
    Sexually Transmitted Infections (STI) incidence will be defined as a positive test result for Neisseria gonorrhoeae, Chlamydia trachomatis, and syphilis in participants who formerly tested negative for STIs.
  • HCV Incidence [ Time Frame: Up to 18 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

Estimated Enrollment: 500
Study Start Date: November 14, 2019
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: On-site Integrated Care with Adherence Counseling
Participants randomized to the on-site integrated care with adherence counselling arm will be prescribed pre-exposure prophylaxis (PrEP) (Truvada®) and, if indicated, Hepatitic 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

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.

Experimental: Off-site Referral to Specialized Care with Patient Navigation
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

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.

Detailed Description:

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 64 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:
Individuals must meet the following criteria to be eligible to participate in the RCT:

    1. be 18-64 years of age
    2. report injection drug use in the past 6-months
    3. be HIV negative
    4. provide informed consent
    5. complete a medical release form
    6. report living in the vicinity and being able to return for follow-up over 18-months
    7. be willing to use a medically acceptable form of contraception throughout the study duration (for women of childbearing potential)
    8. be able to communicate in English, French, or Spanish (site dependent)
    9. 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:
    1. have completed the first 6 months of RCT follow up;
    2. be able and willing to provide informed consent.


Exclusion Criteria:

    Individuals will be excluded from the RCT if they:
    1. 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.
    2. 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.
    3. have chronic renal failure
    4. have or have history of decompensated cirrhosis
    5. are HIV-positive or have symptoms of an acute HIV infection
    6. are pregnant (verified via pregnancy test), are planning to be pregnant during the course of the study, or breastfeeding
    7. have an allergy or contraindication to one of the study medications
    8. 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)
    9. are currently on PrEP and/or HCV treatment.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03981445

    Locations

    United States, Florida
    Miami Not yet recruiting
    Miami, Florida, United States, 33136
    Contact: Lauren Gooden, Ph.D    786-703-9819    lkg2129@cumc.columbia.edu
    Canada
    Montreal Recruiting
    Montreal, Quebec, Canada
    Contact: Aïssata Sako    514-890-8000 ext 30936    aissata.sako.chum@ssss.gouv.qc.ca

    Sponsors and Collaborators

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

    Investigators

    Principal Investigator: 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
    More Information

    More Information


    Responsible Party: Lisa Metsch, Dean of General Studies, Columbia University  
    ClinicalTrials.gov Identifier: NCT03981445   History of Changes  
    Other Study ID Numbers: AAAR5478  
      R01DA045713  
    Study First Received: June 6, 2019  
    Last Updated: March 3, 2020  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  
    Product Manufactured in and Exported from the U.S.: Yes  

    Keywords provided by Lisa Metsch, Columbia University:

    PrEP
    HCV Treatment
    Injection Drug Use

    ClinicalTrials.gov processed this data on June 02, 2020
    This information is provided by ClinicalTrials.gov.