Integrated HIV Prevention and HCV Care for PWID

Opioid Use Clinical Trial

— M2HepPrEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981445
• Other study ID #: AAAR5478
• Secondary ID: R01DA045713
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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 or French (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 (RCT participant interviews);

2. provide informed consent;

3. have contributed to assessments/interviews, intervention and/or treatment follow-ups (staff interviews). 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.

10. 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.

Related Conditions & MeSH terms

• HCV
• HIV Prevention
• Intravenous Drug Usage
• Opioid Use

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Montreal	Montreal	Quebec
United States	Miami	Miami	Florida

Sponsors (8)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained PrEP adherence	Average proportion of Dried Blood Spots (DBS) with detectable levels of Tenofovir at 6 months	6 months post randomization
Primary	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	Long-term sustained PrEP Adherence	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.	Up to 12 months
Secondary	Behavioral disinhibition	Proportion of participants who increase sexual or injection risk behaviors as measured by self- report questionnaires administered at each research visit.	Up to 12 months
Secondary	STI or HIV incidence	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).	Up to 12 months
Secondary	HCV Incidence	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	Up to 12 months
Secondary	PrEP Initiation/Uptake	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.	Up to 12 months