Administrative information
Title | M2HepPrEP: A Multi-Site Multi-Setting Randomized Controlled Trial of Integrated HIV Prevention and HCV Care for PWID |
Trial registration | NCT03981445 |
Protocol version | Protocol version 1.0 |
Funding | NIH NIDA: study funding (R01DA045713) Gilead Sciences®:: Medication |
Author details | Centre de recherche du Centre hospitalier de l’Université de Montréal Medical microbiology and infectious diseases service, Centre hospitalier de l’Université de Montréal Microbiology, infectious diseases and immunology, Université de Montréal Mailman School of Public Health Columbia University Department of Sociomedical Sciences Weill Cornell Medical College Department of Population Health Sciences Département de médecine familiale et de médecine d’urgence, Université de Montréal CIUSSS Centre-Sud-de-l’Île-de-Montréal CACTUS Montréal Jackson Memorial Hospital Department of Public Health Sciences, Biostatistics Division, University of Miami Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University Centre hospitalier de l’Université de Montréal Department of family and emergency medicine, Université de Montréal |
Name and contact information for the trial sponsor | Guifang Lao, M.D., PhD. Health Scientist Administrator/Program Officer laog@mail.nih.gov [laog@mail.nih.gov] |
Role of sponsor | The National Institute on Drug Abuse, the study sponsor, and Gilead Sciences®, provider of study medication, are not directly involved in study design, collection, and management analysis of data or writing of reports. They also will not have any role in submission of publication. NIDA does review period summary reports for progress. Gilead does receive medication-related safety data. |
Introduction
Background and rationale (6a)
Objectives (7)
Trial design (8)
Sites | Miami | Montréal | ||
---|---|---|---|---|
Golden Glades Treatment Center | IDEA | Programme Relais du CIUSSS Centre-Sud-de-l’Île-de-Montréal | Cactus Montréal | |
Type | OAT clinic | SSP | OAT low threshold clinic | SSP |
Funding | Private Insurance, Medicaid and Self-Pay | Private donations | Public | Public |
Physicians on site | Yes | Weekly | On week day | No |
Specialized in addiction | Yes | Yes | Yes | Yes |
Number of physicians | 2 | 2 | 5 | 0 |
Number of nurses | 7 | 1 | 3 | 0,1 |
Other resources onsite | Counselling, drug testing, HIV prevention | OAT, wound care, HIV care | Standard and alternative OAT, primary care, provincial medical care card dispensing services, others | STI and hepatitis prevention education, telemedicine OAT clinics, HCV testing, sex worker/transgender person support |
Clients per year | 250 | 500–700 | 200–300 | 500–700 |
Methods: participants, interventions, and outcomes
Study setting (9)
Eligibility criteria (10)
Who will take informed consent? (26a) Additional file 3
Additional consent provisions for collection and use of participant data and biological specimens (26b)
Interventions
Explanation for the choice of comparators (6b)
Intervention description (11a)
Pre-screening
Screening
Assessment name | Pre-SCR | SCR | BSL | 8 w | 12 w | 3M | 16 w | 20 w | 6M | 9M | 12M | 15M | 18M | As clinically prescribed |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Point-of-care HIV, HCV, and pregnancy rapid testing | X | X | ||||||||||||
Hepatitis A virus test, anti-HBs, anti-HBc | X | X | ||||||||||||
Pregnancy and birth control assessment | X | X | X | X | X | X | X | X | ||||||
Medical and psychiatric history | X | |||||||||||||
Physical exams and vital signs | X | X | ||||||||||||
HCV Ab, HCV RNA | X | X | X | X | X | X | X | X | X | |||||
Liver and kidney function | X | X | X | |||||||||||
HIV, syphilis, chlamydia, gonorrhea, and hepatitis B | X | X | X | X | X | X | X | |||||||
Concomitant medications | X | X | X | X | X | X | X | |||||||
Adverse events and serious adverse events | X | X | X | X | X | X | X | |||||||
Treatment | ||||||||||||||
Clinical management | X | X | ||||||||||||
Dried blood spot | X | X | X | X | X | X | X | X | X | X | ||||
HCV treated participants | ||||||||||||||
HCV RNA | 12w post-Tx initiation, 12w post-end of treatment |
Assessment name | Pre-SCR | SCR | BSL | 3M | 6M | 9M | 12M | 15M | 18M |
---|---|---|---|---|---|---|---|---|---|
Verbal consent and pre-screening questionnaire | X | ||||||||
Screening informed consent form | X | ||||||||
Locator form | X | X | X | X | X | X | X | X | |
Medical release authorization forms | X | ||||||||
Injection drug use and eligibility questionnaire | X | ||||||||
HIV and HCV testing history and readiness, knowledge | X | ||||||||
Demographic questionnaire, health literacy | X | ||||||||
Trial informed consent form | X | ||||||||
Full sociodemographic survey | X | X | X | X | X | X | X | ||
Substance use profile | X | X | X | X | X | X | X | ||
Alcohol use, drug use | X | X | X | X | |||||
Injection profile, needle access, sharing needles and works | X | X | X | X | X | X | X | ||
Overdose history survey | X | X | X | X | |||||
Attitudes towards HIV, attitudes towards HCV | X | ||||||||
Experience of illness scale | X | X | X | ||||||
Medical mistrust | X | ||||||||
History of abuse and interpersonal violence | X | X | X | X | |||||
Social support and conflictual social interaction | X | ||||||||
Brief Pain Inventory | X | X | X | X | X | X | X | ||
Brief Symptom Inventory | X | X | X | X | X | X | X | ||
Household Food Survey | X | X | X | X | X | X | X | ||
EuroQol-5D-5L | X | ||||||||
Crime and legal activities | X | X | X | X | X | X | X | ||
Non medical and other services | X | X | X | X | X | X | X | ||
Access to care | X | X | X | X | |||||
Sexual behavior | X | X | X | X | X | X | X | ||
Condom use | X | X | X | X | |||||
Communicating w/ physician about PrEP/HCV Tx self-efficacy | X | X | X | ||||||
Relationship with physician | X | X | X | ||||||
PrEP adherence HCV-PA1 and 2 | X | X | X | X | X | X | |||
Adherence counseling/patient navigation satisfaction survey | EOI |
Randomization
Provision of other medical care (both arms)
Medication
Criteria for discontinuing or modifying allocated interventions (11b)
HIV seroconversion
Pregnancy
Renal function impairment
HCV treatment
Strategies to improve adherence to interventions (11c)
Relevant concomitant care permitted or prohibited during the trial (11d)
Provisions for post-trial care (30)
Outcomes (12)
Primary outcome measures
Secondary outcomes | Definition | Measure |
---|---|---|
PrEP initiation/uptake | Receiving a prescription and taking the first dose of the medication | First dose of Rx dispensed to the patient and recorded at pharmacy/dispensing venue + self-report |
Long-term sustained PrEP adherence | PrEP use at 6, 12, and 18 months post-randomization | Self-report + detectable level of TDF in DBS 6, 12, and 18 months post-randomization |
HCV incidence/re-infection | New HCV infection | At scheduled visit: HCV-Ab positive (never infected) or detectable HCV-RNA (previously infected and cured) |
STI or HIV incidence/STI re-infection | New STI or HIV infection in a previously uninfected person/previously infected and cured person | At scheduled visit: Any positive test result for Neisseria gonorrheae, Chlamydia trachomatis, syphilis, or HIV |
Behavioral disinhibition | Changes or increase in sexual or injection risk behaviors | Self-report at each visit |
Tertiary outcomes | Definition | Measure |
Ongoing PrEP use | Any PrEP use during any period | Any detectable level of TDF in DBS/Self-report of use |
HCV SVR within those initiating | 12-week sustained viral response post-end of treatment | First dose of medication dispensed to the patient and recorded at pharmacy/dispensing venue + self-report/HCV-RNA negative at 12 weeks post end of treatment |