Clinical trial

Providing Comprehensive Harm Reduction Via Telemedicine for PWID Using Syringe Services Programs: a Feasibility Study

Name
Pro00104147
Description
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program. The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.
Trial arms
Trial start
2020-11-09
Estimated PCD
2021-08-30
Trial end
2021-08-30
Status
Completed
Treatment
Suboxone
Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
Arms:
Medication and telemedicine follow up
PrEP
Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
Arms:
Medication and telemedicine follow up
Other names:
Pre-Exposure Prophylaxis (PrEP)
Size
17
Primary endpoint
Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months
3 months
Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months
6 months
Number of Participants Who Remain HIV Negative at 3 Months
3 months
Number of Participants Who Remain HIV Negative at 6 Months
6 months
Persistence in Care at 3 Months
3 months
Persistence in Care at 6 Months
6 months
Eligibility criteria
Inclusion Criteria: * History of self-report injection opioid use in the past 6 months * Participate in SSPs, * HIV negative * Willing to take bup/nx and PrEP for 6 months * No medical contraindications for these medications * Not pregnant * 18 years or older * Not currently taking PrEP * Not currently taking any form of MOUD * History of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV (such as engaging in sex work or men who have sex with men) in the past 6 months Exclusion Criteria: * Positive pregnancy test including during the course of the study * Positive HIV test at enrollment * Altered mental status in which participant cannot sign a consent form * Renal insufficiency/failure * Hepatitis B surface antigen positive * Becoming incarcerated during the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}
Updated at
2023-06-09

1 organization

2 products

4 indications

Organization
Duke University
Product
Suboxone
Indication
Opioid Use
Indication
Risk Reduction
Indication
HIV
Product
PrEP