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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The purpose of this randomized study is to determine whether a community-based test and treat model of hepatitis C (HCV) care delivery will be superior to the usual care practice of referral to specialist clinics for the outcomes of sustained virologic response at 12 weeks after treatment and initiation of HCV treatment for persons who inject drugs (PWID) between ages 18 and 29 who are naïve to HCV treatment
ST&RT is a randomized open-label clinical trial in which 54 HCV infected PWID between ages 18 and 29 will be randomized to either receive the same-day treatment initiation of the FDA-approved fixed dose combination of sofosbuvir 400mg and velpatasvir 100mg (SOF/VEL) with follow up and medical monitoring at a community site (Intervention arm) or to receive referral to an HCV treatment provider's office (Usual Care Arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Treatment with sofosbuvir/velpatasvir (Intervention arm) | Experimental | The intervention arm receives same-day medical evaluation and treatment for hepatitis C. They receive medical evaluation, laboratory assessment , baseline questionnaire/interview, and distribution of a medication (sofosbuvir/velpatasvir) "starter pack" on the day of enrollment. Participants who are HCV RNA negative are followed separately and do not receive intervention. Other participants start medications and receive weekly text messages during treatment to record adherence. They have follow up visits for laboratory tests, medication distribution, and counseling for prevention of reinfection. They have HCV testing at end of treatment and 12 weeks post treatment, and at 48 weeks to assess for reinfection. Each study visit will include a brief questionnaire and qualitative interview. |
|
| Usual Care (Control arm) | Active Comparator | Participants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then followed separately. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response. |
|
| HCV RNA negative | No Intervention | Participants assigned to either group who were found to be HCV RNA-negative at entry. They are not eligible for treatment and thus not part of the analysis. They were asked to return the treatment starter pack. They are followed with HCV RNA measured at Week 24 and 48. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid Treatment strategy | Other | The intervention arm receives same-day medical evaluation and treatment for hepatitis C. They receive medical evaluation, laboratory assessment , baseline questionnaire/interview, and distribution of a medication (sofosbuvir/velpatasvir) "starter pack" on the day of enrollment. Participants who are HCV RNA negative are discontinued from the study. Other participants start medications and receive weekly text messages during 12 weeks of provided sofusbuvir/velpatasvir treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care | The proportion of participants who achieve sustained virologic response defined as an undetectable HCV RNA viral load 12 weeks after the cessation of treatment (SVR12), in the intervention arm compared to the usual care arm by study week 48. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants Who Initiate Treatment for HCV | The proportion of participants who initiate treatment for HCV in the intervention arm compared to the usual care arm by study week 48. | Week 48 |
| Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Marks | Weill Cornell MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lower East Side Harm Reduction Center | New York | New York | 10022 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline RNA-positive Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | The intervention arm receives same-day medical evaluation and treatment for hepatitis C. They receive medical evaluation, laboratory assessment , baseline questionnaire/interview, and distribution of a medication (sofosbuvir/velpatasvir) "starter pack" on the day of enrollment. Participants who are HCV RNA negative are discontinued from the study. Other participants start medications and receive weekly text messages during treatment to record adherence. They have follow up visits for laboratory tests, medication distribution, and counseling for prevention of reinfection. They have HCV testing at end of treatment and 12 weeks post treatment, and at 48 weeks to assess for reinfection. Each study visit will include a brief questionnaire and qualitative interview. Sofosbuvir and Velpatasvir: Sofosbuvir/velpatasvir (Epclusa) is an FDA-approved treatment for HCV. It is provided in the intervention arm as part of a rapid treatment strategy, |
| FG001 | Baseline RNA-positive Usual Care (Control Arm) | Participants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then discontinued from the study. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response. |
| FG002 | Baseline RNA Negative | Participants assigned to either group who were found to be HCV RNA-negative at entry. They are not eligible for treatment and thus not part of the analysis. They were asked to return the treatment starter pack. They are followed with HCV RNA measured at Week 24 and 48. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant was deemed ineligible after randomization and is not included. Participants found to be RNA negative at baseline are listed separately since they do not have hepatitis C infection and are not eligible for treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline RNA-positive Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | The intervention arm receives same-day medical evaluation and treatment for hepatitis C. They receive medical evaluation, laboratory assessment , baseline questionnaire/interview, and distribution of a medication (sofosbuvir/velpatasvir) "starter pack" on the day of enrollment. Participants who are HCV RNA negative are discontinued from the study. Other participants start medications and receive weekly text messages during treatment to record adherence. They have follow up visits for laboratory tests, medication distribution, and counseling for prevention of reinfection. They have HCV testing at end of treatment and 12 weeks post treatment, and at 48 weeks to assess for reinfection. Each study visit will include a brief questionnaire and qualitative interview. Sofosbuvir and Velpatasvir: Sofosbuvir/velpatasvir (Epclusa) is an FDA-approved treatment for HCV. It is provided in the intervention arm as part of a rapid treatment strategy, |
| 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 | The Proportion of Participants Who Achieve Sustained Virologic Response 12 (SVR12) With Rapid Treatment Strategy Compared to Usual Care | The proportion of participants who achieve sustained virologic response defined as an undetectable HCV RNA viral load 12 weeks after the cessation of treatment (SVR12), in the intervention arm compared to the usual care arm by study week 48. | Thirteen participants who were HCV-RNA negative at baseline excluded from analysis since they do not have hepatitis C and are not eligible for treatment. One participant in the intervention arm was deemed ineligible after randomization and was not included in analysis. | Posted | Count of Participants | Participants | Week 48 |
|
12 months
Thirteen participants who were HCV-RNA negative at baseline excluded from analysis since they do not have hepatitis C and are not eligible for treatment. One participant in the intervention arm was deemed ineligible after randomization and was not included in analysis. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group
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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 | Rapid Treatment With Sofosbuvir/Velpatasvir (Intervention Arm) | The intervention arm receives same-day medical evaluation and treatment for hepatitis C. They receive medical evaluation, laboratory assessment , baseline questionnaire/interview, and distribution of a medication (sofosbuvir/velpatasvir) "starter pack" on the day of enrollment. Participants who are HCV RNA negative are discontinued from the study. Other participants start medications and receive weekly text messages during treatment to record adherence. They have follow up visits for laboratory tests, medication distribution, and counseling for prevention of reinfection. They have HCV testing at end of treatment and 12 weeks post treatment, and at 48 weeks to assess for reinfection. Each study visit will include a brief questionnaire and qualitative interview. Sofosbuvir and Velpatasvir: Sofosbuvir/velpatasvir (Epclusa) is an FDA-approved treatment for HCV. It is provided in the intervention arm as part of a rapid treatment strategy, |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug overdose | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Marks | Weill Cornell Medicine | 212-746-4177 | markskr@med.cornell.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 | Jun 17, 2020 | Apr 8, 2022 | 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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|
| Usual Care (facilitated referral) | Other | articipants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then followed separately. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response. |
|
| 48 wks |
| Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48 | 48 wks |
| Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Change in substance use frequency or injection risk behaviors will be defined as percent of participants in each arm that injected alone and the percent of participants who injected with 3 or more individuals | Baseline and 48 weeks |
| BG001 | Baseline RNA-positive Usual Care (Control Arm) | Participants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then discontinued from the study. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response. |
| BG002 | Baseline RNA Negative | Participants assigned to either group who were found to be HCV RNA-negative at entry. They are not eligible for treatment and thus not part of the analysis. They were asked to return the treatment starter pack. They are followed with HCV RNA measured at Week 24 and 48. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care (Control Arm) | Participants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then discontinued from the study. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response. |
|
|
|
| Secondary | The Proportion of Participants Who Initiate Treatment for HCV | The proportion of participants who initiate treatment for HCV in the intervention arm compared to the usual care arm by study week 48. | Thirteen participants who were HCV-RNA negative at baseline excluded from analysis since they do not have hepatitis C and are not eligible for treatment. One participant in the intervention arm was deemed ineligible after randomization and was not included in analysis. | Posted | Count of Participants | Participants | Week 48 |
|
|
|
|
| Secondary | Presence of Resistance Associated Substitutions (RAS) in Treated Patients With Treatment Failure | Resistance testing data was not collected. | Posted | 48 wks |
|
|
| Secondary | Number of Participants in Both Arms Who Achieve SVR12, or Are RNA Negative at Baseline, That Have HCV Reinfection by Study Week 48 | Posted | Count of Participants | Participants | 48 wks |
|
|
|
| Secondary | Impact of Engagement in HCV Treatment on Frequency of Substance Use or Injection Risk Behaviors | Change in substance use frequency or injection risk behaviors will be defined as percent of participants in each arm that injected alone and the percent of participants who injected with 3 or more individuals | Thirteen participants who were HCV-RNA negative at baseline excluded from analysis since they do not have hepatitis C and are not eligible for treatment. Not all participants completed the survey at Week 48. | Posted | Count of Participants | Participants | Baseline and 48 weeks |
|
|
|
| 0 |
| 14 |
| 6 |
| 14 |
| 0 |
| 14 |
| EG001 | Usual Care (Control Arm) | Participants in the control arm will be provided facilitated referral to community HCV providers by an on-site care coordinator already facilitating care at the community site. HCV RNA negative participants will be called to inform them of these results, and then discontinued from the study. HCV RNA positive participants will be asked during the semi-structured interviews as at 12, 24, 36 and 48 week if they engaged in HCV treatment to assess whether their HCV referral has been filled, and to record their current HCV treatment status. They will also receive repeat HCV RNA testing at week 12, 24, and 48. Participants that have started treatment will be asked to sign consent for release of medical records pertaining to HCV-related laboratory testing to determine achievement of treatment response. | 0 | 11 | 5 | 11 | 0 | 11 |
| EG002 | Baseline RNA Negative | Participants assigned to either group who were found to be HCV RNA-negative at entry. They are not eligible for treatment and thus not part of the analysis. They were asked to return the treatment starter pack. They are followed with HCV RNA measured at Week 24 and 48. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed in the "Baseline RNA Negative" Arm/Group | 0 | 0 | 0 | 0 | 0 | 0 |
| Skin/soft tissue infection | Infections and infestations | Systematic Assessment |
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| pneumonia | Infections and infestations | Systematic Assessment |
|
| miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Spleen laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Seizure from withdrawal | Nervous system disorders | Systematic Assessment |
|
| GI bleed | Gastrointestinal disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Injected with 1-2 indivuduals |
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| Injected alone |
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| Did not inject |
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| Week 48 |
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