Integrated HIV Prevention and HCV Care for PWID

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Sustained PrEP adherence — 6 months post randomization
  Average proportion of Dried Blood Spots (DBS) with detectable levels of Tenofovir at 6 months
• HCV cure among HCV positive strata — 6-months post treatment initiation
  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.

Trial sites (3)

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