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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test and Treat plus Peer Mentors Intervention Arm | Experimental | Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support. |
|
| Standard of Care Referral Arm | Active Comparator | Participants referred to offsite (non-OTP) location for HCV treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test and treat plus peer mentors | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Initiate HCV Therapy | Participants who start HCV treatment in each arm. | Within 12 weeks of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| HCV Treatment Completion | Participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course). | At expected end of treatment date, up to 20 weeks |
| Sustained Virologic Response (SVR) Following Treatment by Intervention Group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oluwaseun Falade-Nwulia, MBBS, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of California, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42163934 | Derived | 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. |
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198 participants were screened and consented. 16 participants were ineligible for randomization (for 3 participants, they were unable to collect blood, 12 participants had undetectable HCV RNA, and 1 participant was excluded per investigator decision). The remaining 182 were randomized.
Participants were recruited at five community sites - four in the United States and one in Canada. All sites were Opioid Treatment Programs (OTPs). Participants were recruited through staff referrals, on-site table events manned by research staff, as well as recruitment flyers and self-referrals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test and Treat Plus Peer Mentors Intervention Arm | Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support. Test and treat plus peer mentors: 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. |
| FG001 | Standard of Care Referral Arm | Participants referred to offsite (non-OTP) location for HCV treatment. Usual care: Participants are referred to another location for HCV treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who were eligible for treatment initiation based on protocol criteria, excluding two participants from the analysis due to randomization error. Analyses were conducted with a modified intention to treat of approach, which excluded randomized participants who were found on testing to have an undetectable HCV RNA, HBsAg positive or a platelet count <150,000.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test and Treat Plus Peer Mentors Intervention Arm | Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support. Test and treat plus peer mentors: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Who Initiate HCV Therapy | Participants who start HCV treatment in each arm. | Participants who were eligible for treatment initiation based on protocol criteria, excluding two participants from the analysis due to randomization error. Analyses were conducted with a modified intention to treat of approach, which excluded randomized participants who were found on testing to have an undetectable HCV RNA, HBsAg positive or a platelet count <150,000. | Posted | Count of Participants | Participants | Within 12 weeks of randomization |
|
Treatment day 1 up to 30 days post treatment initiation
All Grade 3 or higher and all SAEs related to the use of Glecaprevir/pibrentasvir (GLE/PIB) in intervention arm or prescribed DAA course in SOC arm were to be collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test and Treat Plus Peer Mentors Intervention Arm | Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support. Test and treat plus peer mentors: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oluwaseun Falade-Nwulia, MBBS, MPH | Johns Hopkins University | 4105506234 | ofalade1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2024 | Mar 3, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D003033 | Coal Tar |
| ID | Term |
|---|---|
| D013638 | Tars |
| D045424 | Complex Mixtures |
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|
| Usual care | Other | Participants are referred to another location for HCV treatment. |
|
|
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. |
| Post-treatment week 12 |
| Time to HCV Treatment Initiation | Time to HCV Treatment Initiation in weeks. | From randomization to initiation of treatment, up to 24 weeks |
| San Francisco |
| California |
| 94143 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| University Health Network Toronto | Toronto | Ontario | M5G 2C4 | Canada |
| Participants refused to complete study visits |
|
| Unable to come in for visits |
|
| Death |
|
| Excluded from analysis - randomization error |
|
| BG001 |
| Standard of Care Referral Arm |
Participants referred to offsite (non-OTP) location for HCV treatment. Usual care: Participants are referred to another location for HCV treatment. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Injection drug use reported in the past 30 days | Participants who reported injection drug use at baseline - As part of study interview, participants were asked what their usual route of drug administration was per drug type used in the past 30 days (heroin, cocaine, other opiates/ analgesics, amphetamine, sedatives/hypnotics and barbiturates). | Count of Participants | Participants |
|
| Positive urine drug screen results at baseline - Any drug | Participants with positive drug screen at baseline. The drug screen analytes required in the urine drug test are amphetamine; barbiturate; benzodiazepines; cocaine or benzoylecgonine; fentanyl; methadone; opiates; oxycodone/oxymorphone; phencyclidine (PCP); propoxyphene; tramadol. | Count of Participants | Participants |
|
| OG001 | Standard of Care Referral Arm | Participants referred to offsite (non-OTP) location for HCV treatment. Usual care: Participants are referred to another location for HCV treatment. |
|
|
|
| Secondary | HCV Treatment Completion | Participants who start HCV treatment and subsequently complete treatment (take more than 90% of prescribed treatment course). | Participants who initiated and completed HCV Therapy | Posted | Count of Participants | Participants | At expected end of treatment date, up to 20 weeks |
|
|
|
|
| Secondary | 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. | Participants who achieved SVR among participants who initiated HCV treatment within 12 weeks | Posted | Count of Participants | Participants | Post-treatment week 12 |
|
|
|
|
| Secondary | Time to HCV Treatment Initiation | Time to HCV Treatment Initiation in weeks. | Participants who were eligible for treatment initiation based on protocol criteria, excluding two participants from the analysis due to randomization error. Analyses were conducted with a modified intention to treat of approach, which excluded randomized participants who were found on testing to have an undetectable HCV RNA, HBsAg positive or a platelet count <150,000. | Posted | Median | Inter-Quartile Range | Weeks | From randomization to initiation of treatment, up to 24 weeks |
|
|
|
|
| 0 |
| 91 |
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | Standard of Care Referral Arm | Participants referred to offsite (non-OTP) location for HCV treatment. Usual care: Participants are referred to another location for HCV treatment. | 1 | 89 | 0 | 89 | 0 | 89 |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |