Clinical trial NCT03981445: Integrated HIV Prevention and HCV Care for PWID
Official title: A Multi-site Multi-Setting Randomized Controlled Trial (RCT) of Integrated HIV Prevention and HCV Care for People Who Inject Drugs (PWID)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Prevention
HCV
Opioid Use
Intravenous Drug Usage
Keywords: PrEP
HCV Treatment
Injection Drug Use
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: University of Miami
name: Weill Medical College of Cornell University
name: Université de Sherbrooke
name: Simon Fraser University
name: National Institute on Drug Abuse (NIDA)
name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2019-06-10
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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 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 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.

Primary outcomes:
measure: Sustained PrEP adherence
timeFrame: 6 months post randomization
measure: HCV cure among HCV positive strata
timeFrame: 6-months post treatment initiation
Secondary outcomes:
measure: Long-term sustained PrEP Adherence
timeFrame: Up to 12 months
measure: Behavioral disinhibition
timeFrame: Up to 12 months
measure: STI or HIV incidence
timeFrame: Up to 12 months
measure: HCV Incidence
timeFrame: Up to 12 months
measure: PrEP Initiation/Uptake
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami
state: Florida
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Montreal
country: Canada
facility: Montreal
state: Quebec
Study officials:
affiliation: Columbia University
name: Lisa R Metsch, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Julie Bruneau, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Daniel Feaster, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Valérie Martel-Laferrière, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.