Patient Navigation & Counseling for HIV Prevention and Hepatitis C
(M2HepPrEP Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently on PrEP or Hepatitis C treatment. It seems you may need to stop these specific treatments to participate.
What data supports the effectiveness of the treatment Adherence Counseling, ARTAS Adapted Patient Navigation for HIV Prevention and Hepatitis C?
Research shows that patient navigation programs, like Check Hep C, have successfully helped patients start and stick with their treatment, leading to high cure rates for Hepatitis C. Additionally, studies indicate that patient navigation is positively associated with better HIV care outcomes, such as staying in care and taking medication regularly.12345
Is patient navigation and counseling for HIV prevention and Hepatitis C safe for humans?
How does the patient navigation and counseling treatment for HIV prevention and Hepatitis C differ from other treatments?
This treatment is unique because it uses patient navigation, which involves personalized guidance and support to help patients access and adhere to care, addressing barriers like social determinants of health. Unlike standard treatments that focus solely on medication, this approach integrates counseling and coordination to improve health outcomes, especially in underserved populations.19101112
What is the purpose of this trial?
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.
Research Team
Julie Bruneau, M.D.
Principal Investigator
Université de Montréal
Lisa R Metsch, Ph.D
Principal Investigator
Columbia University
Daniel Feaster, Ph.D
Principal Investigator
University of Miami
Valérie Martel-Laferrière, MD
Principal Investigator
Université de Montréal
Eligibility Criteria
This trial is for individuals aged 18-64 who inject drugs, are HIV negative, and can commit to an 18-month follow-up. They must live nearby, consent to the study's terms, use contraception if applicable, speak English or French depending on location, and be clients at opioid therapy clinics or syringe programs. Exclusions include severe medical or mental conditions that affect safe participation or informed consent ability.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either on-site integrated care with adherence counseling or off-site referral to specialized care with patient navigation for PrEP and, if necessary, HCV treatment.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including HCV cure and PrEP adherence.
Long-term Follow-up
Participants are monitored for long-term outcomes such as behavioral disinhibition, STI or HIV incidence, and long-term PrEP adherence.
Treatment Details
Interventions
- Adherence Counseling
- ARTAS Adapted Patient Navigation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
University of Miami
Collaborator
Weill Medical College of Cornell University
Collaborator
Université de Sherbrooke
Collaborator
Simon Fraser University
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator
Université de Montréal
Collaborator