Hepatitis C Virus Infection, Response to Therapy ofRAPID-HCVNCT04677153
Rapid HCV Treatment Access for Persons Who Use Drugs
A study testing Test and treat plus peer mentors in people with Hepatitis C Virus Infection, Response to Therapy of, run by Johns Hopkins University at 4 sites in 2 countries.
Trial summary
This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C Virus Infection, Response to Therapy of
- What is being tested?
- Test and treat plus peer mentors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 6 Aug 2021to 23 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness of participant to provide written informed consent
- Men and women age ≥18 to ≤70 years at study entry
- HCV antibody positive/detectable HCV RNA
- HCV treatment naïve (no prior treatment with an approved or investigational oral Direct-Acting Antivirals (DAA) therapy
- Negative pregnancy test at screening or at the day of treatment initiation (females of childbearing potential only)
- If co-infection with Human Immunodeficiency Virus (HIV) is documented, the subject must be anti-retroviral treatment (ART) naïve with CD4 T cell count >500 cells/mm3 OR on a stable ART regimen (containing only permissible ART - Raltegravir; dolutegravir; Rilpivirine; Elvitegravir/cobicistat; Tenofovir disoproxil fumarate; Tenofovir alafenamide; Emtricitabine; Lamivudine and/or Abacavir, bictegravir)
Who cannot join
- Women who are pregnant or breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
- Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry
- History of hepatocellular carcinoma (HCC)
- Any history of active Hepatitis B or positive HBsAg test
- Platelet count < 150,000/mm3
Show all 11Show fewer
- HCV RNA undetectable
- History of clinically significant abnormalities or co-morbidities that make the subject an unsuitable candidate for this study, in the opinion of the investigator.
- Women of childbearing potential that are not practicing at least one specified method of birth control that is effective from Study Day 1 through at least 30 days after the last dose of study drug.
- Subject is currently taking any of the following prohibited medications: red yeast rice (monacolin K), St. John's Wort, carbamazepine, dabigatran, efavirenz, phenytoin, pentobarbital, phenobarbital, primidone, rifabutin, rifampin.
- Subject is not able or willing to safely discontinue the prohibited medications or supplements listed below at least 14 days prior to the first dose of GLE/PIB: some HMG-CoA reductase inhibitors, astemizole, cisapride, terfenadine, ethinyl estradiol.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama
Birmingham, Alabama, 35294
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Rapid HCV Test and Treat to Increase HCV Treatment Uptake Among People Who Use Drugs
This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups:
- Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection.
- Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.
- Being tested
- Test and treat plus peer mentors, Usual care
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test and treat plus peer mentorsOther
Also called On-site treatment with peer support HCV treatment implementation strategy
Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
Usual careOther
Also called Standard of care referral HCV treatment implementation strategy
Participants are referred to another location for HCV treatment.
| Study group | Role | What they receive |
|---|---|---|
| Test and Treat plus Peer Mentors Intervention Arm | Experimental | Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support. Receives: Other: Test and treat plus peer mentors |
| Standard of Care Referral Arm | Active comparator | Participants referred to offsite (non-OTP) location for HCV treatment. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Who Initiate HCV Therapy
Participants who start HCV treatment in each arm.
Measured: Within 12 weeks of randomization
Secondary outcomes (3)
HCV Treatment Completion
Participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course).
Measured: At expected end of treatment date, up to 20 weeks
Sustained Virologic Response (SVR) Following Treatment by Intervention Group
Participants in each arm who achieved SVR, defined as HCV RNA <15 IU/mL between 10 and 36 weeks after completion of the HCV treatment regimen.
Measured: Post-treatment week 12
Time to HCV Treatment Initiation
Time to HCV Treatment Initiation in weeks.
Measured: From randomization to initiation of treatment, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start6 Aug 2021
- Primary completion23 Feb 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus Infection, Response to Therapy ofStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Oluwaseun Falade-Nwulia, MBBS, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677153
- Sponsor's protocol ID
- IRB00265240
- Acronym
- RAPID-HCV
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2020
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Falade-Nwulia O, Price JC, Feld JJ, Eaton E, Franco RA, Barnaba B, Brown D, Hussain S, Verinumbe T, Wren C, Karimi-Sari H, Hirose K, Cavacuiti C, O'rear ST, Capraru C, Tobin K, Vaidya D, Schwartz S, Sulkowski M. Rapid hepatitis C test and treat with peer support at opioid treatment programs (RAPID HCV): a hybrid effectiveness-implementation type 1 randomized control trial. Lancet Reg Health Am. 2026 Mar 24;57:101439. doi: 10.1016/j.lana.2026.101439. eCollection 2026 May.
PubMed 42163934
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid HCV Test and Treat to Increase HCV Treatment Uptake Among People Who Use Drugs
- ClinicalTrials.gov ID
- NCT04677153
- Acronym / sponsor ID
- RAPID-HCV / IRB00265240
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to compare two strategies to deliver HCV treatment to persons with hepatitis C virus (HCV) who also use drugs and are participating in an outpatient opioid treatment program (OTP). Participants will be randomized into one of two treatment groups:
- Test and treat plus peer-mentors: This treatment group will be offered 8 weeks of glecaprevir/pibrentasvir (an FDA approved HCV treatment) within days of HCV diagnosis at the OTP. Participants in this group will receive treatment adherence support from a peer-mentor who is someone who has been cured of HCV infection.
- Standard of care HCV treatment referral: This treatment group will be referred to an offsite HCV treatment location. This is the usual care for anyone who tests positive for HCV at the OTP who is not participating in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test and Treat plus Peer Mentors Intervention Arm | Experimental | Other: Test and treat plus peer mentorsParticipants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support. |
| Standard of Care Referral Arm | Active comparator | Other: Usual careParticipants referred to offsite (non-OTP) location for HCV treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability and willingness of participant to provide written informed consent
- Men and women age ≥18 to ≤70 years at study entry
- HCV antibody positive/detectable HCV RNA
- HCV treatment naïve (no prior treatment with an approved or investigational oral Direct-Acting Antivirals (DAA) therapy
- Negative pregnancy test at screening or at the day of treatment initiation (females of childbearing potential only)
Key exclusion criteria (11 listed)
- Women who are pregnant or breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation
- Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry
- History of hepatocellular carcinoma (HCC)
- Any history of active Hepatitis B or positive HBsAg test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test and treat plus peer mentorsAlso: On-site treatment with peer support HCV treatment implementation strategyRapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment. | Other | Test and Treat plus Peer Mentors Intervention Arm |
| Usual careAlso: Standard of care referral HCV treatment implementation strategyParticipants are referred to another location for HCV treatment. | Other | Standard of Care Referral Arm |
Primary outcome
Participants Who Initiate HCV Therapy
Time frame: Within 12 weeks of randomization
Participants who start HCV treatment in each arm.
3 secondary outcomes
HCV Treatment Completion
Time frame: At expected end of treatment date, up to 20 weeks
Sustained Virologic Response (SVR) Following Treatment by Intervention Group
Time frame: Post-treatment week 12
Time to HCV Treatment Initiation
Time frame: From randomization to initiation of treatment, up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42163934Falade-Nwulia O, Price JC, Feld JJ, Eaton E, Franco RA, Barnaba B, Brown D, Hussain S, Verinumbe T, Wren C, Karimi-Sari H, Hirose K, Cavacuiti C, O'rear ST, Capraru C, Tobin K, Vaidya D, Schwartz S, Sulkowski M. Rapid hepatitis C test and treat with peer support at opioid treatment programs (RAPID HCV): a hybrid effectiveness-implementation type 1 randomized control trial. Lancet Reg Health Am. 2026 Mar 24;57:101439. doi: 10.1016/j.lana.2026.101439. eCollection 2026 May.
- Individual participant dataSharing planned: No
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Hepatitis C, Transmission, Intravenous Drug Abuser
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oluwaseun Falade-Nwulia, MBBS, MPH principal investigator
Johns Hopkins University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test and treat plus peer mentors in people with Hepatitis C Virus Infection, Response to Therapy of, run by Johns Hopkins University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Who Initiate HCV Therapy (time frame: Within 12 weeks of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.