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

NCT05108935 | Completed

• 2 other identifiers: Pro00104147_15P30AI064518-17
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Opioid Use; Opioid Use Disorder; Risk Reduction; Hiv; Hepatitis C

Keywords

opioid; medication for opioid use disorder; Drug user health hub; syringe services program; syringe exchange; PrEP; HIV prevention; retention in care; Suboxone; Hepatitis C treatment; hepatitis C; Opioid use disorder; feasibility; acceptability

Outcome Measures

Primary Outcomes (17)

• Proportion who demonstrate no or minimal opioid use.

  Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.

  3 months

• Proportion who demonstrate no or minimal opioid use.

  Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.

  6 months

• Proportion who remain HIV negative.

  Measured via negative HIV test.

  3 months

• Proportion who remain HIV negative.

  Measured via negative HIV test.

  6 months

• Among participants who undergo hepatitis C treatment, the hepatitis C cure rate

  Measured via negative hepatitis C test.

  6 months

• Persistence in care

  Defined as the proportion who remain on treatment.

  3 months

• Persistence in care

  Defined as the proportion who remain on treatment.

  6 months

• Ease/difficulty of visiting a SSP to meet with a provider via telemedicine

  Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)

  month 1

• Ease/difficulty of visiting a SSP to meet with a provider via telemedicine

  Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)

  month 6

• Ease/difficulty of accessing the telemedicine video platform

  Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)

  month 1

• Acceptability of medical care via a telemedicine video platform

  Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)

  6 month

• Participant satisfaction with the program

  Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)

  1 month

• Participant satisfaction with the program

  Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)

  month 6

• Participant perceived usefulness of the program

  Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)

  month 1

• Participant perceived usefulness of the program

  Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)

  month 6

• Motivators and barriers affecting program persistence

  Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)

  month 6

• Motivators and barriers affecting medication adherence and persistence

  Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)

  6 months

Study Arms (1)

Medication and telemedicine follow up

EXPERIMENTAL

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.

Drug: Suboxone; Drug: Truvada; Drug: Mavyret

Interventions

Suboxone DRUG

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.

Also known as: Buprenorphine Naloxone

Medication and telemedicine follow up

Truvada DRUG

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.

Also known as: Pre-Exposure Prophylaxis (PrEP)

Medication and telemedicine follow up

Mavyret DRUG

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.

Also known as: Hepatitis C treatment

Medication and telemedicine follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Duke University: lead
• Center for AIDS Research (CFAR): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Duke Department of Population Health Sciences

Durham, North Carolina, 27701, United States

Location

NC Survivors Union

Greensboro, North Carolina, 27403, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Risk Reduction Behavior; Acquired Immunodeficiency Syndrome; Hepatitis C

Interventions

Buprenorphine, Naloxone Drug Combination; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Pre-Exposure Prophylaxis; glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Mehri McKellar, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: February 17, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)