Integrated HIV Prevention and HCV Care for PWID (NCT03981445) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Integrated HIV Prevention and HCV Care for PWID
United States, Canada446 participantsStarted 2019-11-14
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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)