Clinical trial

Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro

Name
Pro00104147_1
Description
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, pre-exposure prophylaxis (PrEP) for HIV prevention, and/or hepatitis C treatment 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 site in Greensboro, North Carolina (NC); follow-up visits will be conducted via telemedicine.
Trial arms
Trial start
2022-02-17
Estimated PCD
2023-03-30
Trial end
2023-03-30
Status
Completed
Treatment
Suboxone
Enrolled participants will be prescribed PrEP Mavyret 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:
Buprenorphine Naloxone
Truvada
Enrolled participants will be prescribed PrEP Mavyret 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)
Mavyret
Enrolled participants will be prescribed PrEP Mavyret 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:
Hepatitis C treatment
Size
17
Primary endpoint
Proportion who demonstrate no or minimal opioid use.
3 months
Proportion who demonstrate no or minimal opioid use.
6 months
Proportion who remain HIV negative.
3 months
Proportion who remain HIV negative.
6 months
Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
6 months
Persistence in care
3 months
Persistence in care
6 months
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
month 1
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
month 6
Ease/difficulty of accessing the telemedicine video platform
month 1
Acceptability of medical care via a telemedicine video platform
6 month
Participant satisfaction with the program
1 month
Participant satisfaction with the program
month 6
Participant perceived usefulness of the program
month 1
Participant perceived usefulness of the program
month 6
Motivators and barriers affecting program persistence
month 6
Motivators and barriers affecting medication adherence and persistence
6 months
Eligibility criteria
Inclusion Criteria: * 18 years or older * Participant in SSP * History of self-report injection opioid use in the past 6 months * Willing to take bup/nx, PrEP, and/or hepatitis C treatment for 6 months * Not currently taking PrEP * HIV negative * Not pregnant * Either a history of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV\* in the past 6 months \*Individuals are considered at risk of sexual acquisition of HIV if they answer yes to any of the items in the below question: In the last 6 months, have any of the following applied to you? * Traded sex for money or drugs * Had a sexual partner who is HIV positive * Did not consistently use condoms when having sex * Had a bacterial sexually transmitted infections (like gonorrhea, chlamydia, or syphilis) * No medical contraindications for these medications such as history of renal failure or bone diseases Exclusion Criteria: * Have altered mental status in which participant cannot sign a consent form * Receive a positive pregnancy test (will be checked at screening visit) * Receive a positive HIV test at enrollment (will be checked at screening visit) * Have evidence of renal failure (will be checked at screening visit) * Have a history of hepatitis B (will be checked at screening visit) * Becoming incarcerated during the study Additional considerations: The following are not exclusion criteria for the study overall, but will affect which treatment(s) they can receive: * Are currently receiving some form of MOUD (buprenorphine, naltrexone, methadone) - this makes them ineligible for MOUD treatment through the study, but they can still receive PrEP and/or hepatitis C treatment * Have received treatment for hepatitis C prior to enrollment - this makes them ineligible for hepatitis C treatment through study, but they can still receive PrEP and/or MOUD
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
2023-04-27

1 organization

3 products

5 indications

Organization
Duke University
Product
Suboxone
Indication
Opioid Use
Indication
Risk Reduction
Indication
HIV
Indication
Hepatitis C
Product
Truvada
Product
Mavyret