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ACTIVE NOT RECRUITING

NCT03981445

Integrated HIV Prevention and HCV Care for PWID

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

446

Start Date

2019-11-14

Completion Date

2025-12-31

Last Updated

2025-10-08

Healthy Volunteers

Yes

Conditions

HIV Prevention HCV Opioid Use Intravenous Drug Usage

Interventions

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.

Inclusion Criteria: Individuals must meet the following criteria to be eligible to participate in the RCT: 1. be 18-64 years of age 2. report injection drug use in the past 6-months 3. be HIV negative 4. provide informed consent 5. complete a medical release form 6. report living in the vicinity and being able to return for follow-up over 18-months 7. be willing to use a medically acceptable form of contraception throughout the study duration (for women of childbearing potential) 8. be able to communicate in English or French (site dependent) 9. be receiving services at an opioid agonist therapy clinic or a syringe access program Individuals must meet the following criteria to be eligible to participate in the qualitative interview: 1. have completed the first 6 months of RCT follow up (RCT participant interviews); 2. provide informed consent; 3. have contributed to assessments/interviews, intervention and/or treatment follow-ups (staff interviews). Exclusion Criteria: Individuals will be excluded from the RCT if they: 1. 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. 2. 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. 3. have chronic renal failure 4. have or have history of decompensated cirrhosis 5. are HIV-positive or have symptoms of an acute HIV infection 6. are pregnant (verified via pregnancy test), are planning to be pregnant during the course of the study, or breastfeeding 7. have an allergy or contraindication to one of the study medications 8. 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) 9. are currently on PrEP and/or HCV treatment. 10. are currently in prison, in any inpatient overnight facility as required by court of law or have a pending legal action, which may prevent an individual from completing the study.

Locations (3)

Miami

Miami, Florida, United States

Columbia University Irving Medical Center

New York, New York, United States

Montreal

Montreal, Quebec, Canada