Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP

• Status: Not yet recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Naloxone

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