NCT03981445

Integrated HIV Prevention and HCV Care for PWID

A Multi-site Multi-Setting Randomized Controlled Trial (RCT) of Integrated HIV Prevention and HCV Care for People Who Inject Drugs (PWID)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Prevention
• HCV
• Opioid Use
• Intravenous Drug Usage

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2019-11-14
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-06-10
• Last updated: 2025-10-08

Locations

3 sites across 2 countries: United States, Canada