Hepatitis CNCT04741750
Increasing HCV Linkage to Care Among People Who Inject Drugs
A study testing Simplified HCV care within a mobile medical unit in people with Hepatitis C, run by Family Health Centers of San Diego at 1 site in United States.
Trial summary
Our study will test the effectiveness of a simplified approach to delivering Hepatitis C Virus (HCV) care in a street-based mobile medical clinic among people who inject drugs in increasing treatment initiation, retention, and cure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Simplified HCV care within a mobile medical unit
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Participants will be positive HCV antibody and positive HCV RNA patients aged 18 years or older who are willing to undergo HCV treatment.
Exclusion Criteria: There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Health Centers of San Diego
San Diego, California, 92102
About this study
Official title: Does a Simplified Algorithm and Integrated HCV Care Improve Linkage to Care, Retention, and Cure Among People Who Inject Drugs? A Pragmatic Quality Improvement Randomized Controlled Trial
Our study will test the effectiveness of a simplified approach to delivering Hepatitis C Virus (HCV) care in a street-based mobile medical clinic among people who inject drugs in increasing treatment initiation, retention, and cure. Rates of HCV treatment initiation, retention, and cure will be compared between patients offered the simplified approach to delivering HCV care in a mobile medical clinic versus those who are linked to a community clinic delivering a current practice of usual care. The investigators hypothesize that the simplified approach to delivering HCV care in a street-based mobile medical clinic will result in higher treatment initiation, retention, and cure than the current practice of usual care in community clinics.
Read the detailed description
With as many as 2.4 million Americans affected by chronic Hepatitis C Virus (HCV), it is one of the most common blood-borne diseases in the United States. Nationwide, rates of new infections have risen dramatically among young adults in their 20s and 30s, the same cohorts most affected by the opioid epidemic, with as many as 70% of new infections related to injection drug use. Local/regional rates of new infection mirror these national surveillance findings. In San Diego, between 2011 and 2016, women aged 20-29 experienced a 62.2% increase in new HCV infections, while new infections among men aged 20-29 spiked 46.6%, with injection drug use cited as the most common form of transmission. Expanded prevalence estimates indicate a population prevalence rate for HCV of 2.0% to 2.7% in San Diego County, suggesting that approximately 65,000 to 88,000 individuals in the region are likely HCV-infected. These alarming increases in new HCV infections demand effective treatment delivered to populations that historically have been difficult to reach and are characterized by disparities in HCV screening, linkage to care, and treatment access due to a constellation of barriers to care. Advances in HCV treatment and care (e.g., the development of highly effective direct-acting antivirals--DAAs) show promise for treating these populations and have led to worldwide HCV elimination goals, as well as local/regional elimination campaigns. While the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA)'s guidelines have long been considered the gold standard for HCV diagnosis, workup, and treatment (and remain appropriate for HCV specialists, especially in complex cases of HCV infection) recent World Health Organization (WHO) HCV guidelines and published consensus statements call for implementation of streamlined and simplified algorithms for HCV care, delivered in an integrated primary care setting. They highlight that most patients, particularly younger people who inject drugs (PWID), have a low risk of cirrhosis, do not require genotyping if treated with pangenotypic regimens, and may be lost to follow-up due to overly complex, time-intensive, and costly evaluations. Furthermore, emerging evidence indicates that PWID achieve the same high cure rates as non-injection drug user patients when treated with DAAs. While research indicates that DAAs have high efficacy and safety and can now be used by primary care providers to treat HCV there are still groups, especially PWID, who experience treatment disparities due to access and treatment barriers. Limited evidence exists to support the effectiveness of expanding screening and treatment access via the use of mobile medical clinics co-located with services for PWID. Only one study to date has shown that point of care testing in a mobile medical clinic resulted in significantly higher rates of HCV infected patients being linked to HCV treatment in 30 days compared to standard phlebotomy HCV testing. Therefore, the proposed study will test the effectiveness of a simplified HCV algorithm with integrated care (including the offer of buprenorphine prescriptions and abscess care), in a street-based mobile clinic setting among PWID, in increasing treatment initiation and retention rates. Rates of HCV treatment initiation and retention will be compared between patients offered a simplified HCV care in a mobile medical clinic versus those who are linked to the current practice of usual care in community clinics.
- Conditions
- Hepatitis C
- Being tested
- Simplified HCV care within a mobile medical unit
- Keywords
- Hepatitis C, Hepatitis C treatment, People who inject drugs, Mobile medical clinic, People experiencing homelessness, Treatment initiation, Linkage to care, Quality improvement
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified HCV care within a mobile medical unitOther
Delivers guideline-based care for HCV in a stream-lined manner on a mobile medical unit
| Study group | Role | What they receive |
|---|---|---|
| Usual Care within Community Clinics | No intervention | Complete blood count, comprehensive metabolic panel, international normalized ratio, HCV RNA, hepatitis B virus (HBV) serologies, point of care HIV test, and point of care liver fibrosis measurement. HCV genotype if required by patient's insurance for prior authorization. Care for opioid use disorder and skin infection is offered. Completion of the initial visit workup is sufficient to initiate a prior authorization request for DAAs from payers and an appointment for MAT follow-up in a community clinic if indicated. Patient coordination; authorization with insurance companies; scheduling appointments, follow-up, and ancillary support services will be conducted by a Patient Navigator. Patients are seen every 2-4 weeks for monitoring and adherence support. HCV treatment regimens are at the discretion of the treating provider in accordance with AASLD/IDSA guidelines and insurance requirements. Twelve weeks after HCV therapy completion, SVR12 HCV RNA and SVR12 CMP tests will be obtained. |
| Simplified Care within a Mobile Medical Unit | Experimental | Simplified Care treatment is the same as for Usual Care with the exception that it is taking place within a mobile medical clinic that is scheduled to deliver treatment in alignment with regular syringe exchange services. Receives: Other: Simplified HCV care within a mobile medical unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who initiate HCV treatment
Initiating treatment with a Direct-Acting Antiviral (DAA)
Measured: 6 months of follow-up
Secondary outcomes (6)
Number of patients who complete HCV treatment
Completing a full treatment course of 8 or 12 weeks of DAA therapy
Measured: 16 weeks after treatment initiation
SVR12 rates
Undetectable HCV RNA on or after the SVR12 time point
Measured: At least 12 weeks following DAA completion
Initiation rates for medication-assisted treatment (MAT) for Opioid Use Disorder
Attendance of at least one visit to a community clinic for treatment of Opioid Use Disorder
Measured: During the first 3 months of follow-up after enrollment
Persistent rate for MAT
> 3 visits for MAT
Measured: During 6 months of follow-up after enrollment
Number of patients who receive abscess care
Treatment for skin infection or abscess
Measured: During 6 months of follow-up after enrollment
Prevalence of engagement in care
The number of visits for any reason during the study period
Measured: During 6 months of follow-up after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start2 Feb 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic quality improvement randomized controlled trial will be conducted among 200 people who inject drugs (PWID) with chronic hepatitis C virus (HCV), age ≥18 years, recruited from Family Health Centers of San Diego's mobile clean syringe exchange program (CSEP). Patients will be recruited to undergo HCV testing. Patients with a positive HCV Ab rapid finger stick test will be randomly allocated (ratio 1:1) to receiving treatment immediately in a mobile medical clinic (n=100) or in a community clinic (n=100, this will serve as a concurrent control group).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Family Health Centers of San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741750
- Sponsor's protocol ID
- GSHCV
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramers CB, Vawter N, Northrup A, Klaman SL, Lewis SV, Tam A, Del Aguila C, Lewis R, Mendez B, Reyes L, Matthews E, Rojas S, Godino JG. Simplified and Integrated Hepatitis C Virus Testing and Treatment Algorithm for Unhoused People Who Inject Drugs. Open Forum Infect Dis. 2025 May 22;12(6):ofaf302. doi: 10.1093/ofid/ofaf302. eCollection 2025 Jun.
PubMed 40476033Klaman SL, Godino JG, Northrup A, Lewis SV, Tam A, Carrillo C, Lewis R, Matthews E, Mendez B, Reyes L, Rojas S, Ramers C. Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol. BMC Infect Dis. 2024 Jan 19;24(1):105. doi: 10.1186/s12879-024-08982-1.
PubMed 38238686
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Simplified Algorithm and Integrated HCV Care Improve Linkage to Care, Retention, and Cure Among People Who Inject Drugs? A Pragmatic Quality Improvement Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04741750
- Acronym / sponsor ID
- GSHCV
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Hepatitis C treatment, People who inject drugs, Mobile medical clinic, People experiencing homelessness, Treatment initiation, Linkage to care, Quality improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Family Health Centers of San DiegoUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study will test the effectiveness of a simplified approach to delivering Hepatitis C Virus (HCV) care in a street-based mobile medical clinic among people who inject drugs in increasing treatment initiation, retention, and cure. Rates of HCV treatment initiation, retention, and cure will be compared between patients offered the simplified approach to delivering HCV care in a mobile medical clinic versus those who are linked to a community clinic delivering a current practice of usual care. The investigators hypothesize that the simplified approach to delivering HCV care in a street-based mobile medical clinic will result in higher treatment initiation, retention, and cure than the current practice of usual care in community clinics.
Detailed description
With as many as 2.4 million Americans affected by chronic Hepatitis C Virus (HCV), it is one of the most common blood-borne diseases in the United States. Nationwide, rates of new infections have risen dramatically among young adults in their 20s and 30s, the same cohorts most affected by the opioid epidemic, with as many as 70% of new infections related to injection drug use. Local/regional rates of new infection mirror these national surveillance findings. In San Diego, between 2011 and 2016, women aged 20-29 experienced a 62.2% increase in new HCV infections, while new infections among men aged 20-29 spiked 46.6%, with injection drug use cited as the most common form of transmission. Expanded prevalence estimates indicate a population prevalence rate for HCV of 2.0% to 2.7% in San Diego County, suggesting that approximately 65,000 to 88,000 individuals in the region are likely HCV-infected. These alarming increases in new HCV infections demand effective treatment delivered to populations that historically have been difficult to reach and are characterized by disparities in HCV screening, linkage to care, and treatment access due to a constellation of barriers to care. Advances in HCV treatment and care (e.g., the development of highly effective direct-acting antivirals--DAAs) show promise for treating these populations and have led to worldwide HCV elimination goals, as well as local/regional elimination campaigns. While the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA)'s guidelines have long been considered the gold standard for HCV diagnosis, workup, and treatment (and remain appropriate for HCV specialists, especially in complex cases of HCV infection) recent World Health Organization (WHO) HCV guidelines and published consensus statements call for implementation of streamlined and simplified algorithms for HCV care, delivered in an integrated primary care setting. They highlight that most patients, particularly younger people who inject drugs (PWID), have a low risk of cirrhosis, do not require genotyping if treated with pangenotypic regimens, and may be lost to follow-up due to overly complex, time-intensive, and costly evaluations. Furthermore, emerging evidence indicates that PWID achieve the same high cure rates as non-injection drug user patients when treated with DAAs. While research indicates that DAAs have high efficacy and safety and can now be used by primary care providers to treat HCV there are still groups, especially PWID, who experience treatment disparities due to access and treatment barriers. Limited evidence exists to support the effectiveness of expanding screening and treatment access via the use of mobile medical clinics co-located with services for PWID. Only one study to date has shown that point of care testing in a mobile medical clinic resulted in significantly higher rates of HCV infected patients being linked to HCV treatment in 30 days compared to standard phlebotomy HCV testing. Therefore, the proposed study will test the effectiveness of a simplified HCV algorithm with integrated care (including the offer of buprenorphine prescriptions and abscess care), in a street-based mobile clinic setting among PWID, in increasing treatment initiation and retention rates. Rates of HCV treatment initiation and retention will be compared between patients offered a simplified HCV care in a mobile medical clinic versus those who are linked to the current practice of usual care in community clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic quality improvement randomized controlled trial will be conducted among 200 people who inject drugs (PWID) with chronic hepatitis C virus (HCV), age ≥18 years, recruited from Family Health Centers of San Diego's mobile clean syringe exchange program (CSEP). Patients will be recruited to undergo HCV testing. Patients with a positive HCV Ab rapid finger stick test will be randomly allocated (ratio 1:1) to receiving treatment immediately in a mobile medical clinic (n=100) or in a community clinic (n=100, this will serve as a concurrent control group).
| Arm | Type | Receives |
|---|---|---|
| Usual Care within Community Clinics | No intervention | –Complete blood count, comprehensive metabolic panel, international normalized ratio, HCV RNA, hepatitis B virus (HBV) serologies, point of care HIV test, and point of care liver fibrosis measurement. HCV genotype if required by patient's insurance for prior authorization. Care for opioid use disorder and skin infection is offered. Completion of the initial visit workup is sufficient to initiate a prior authorization request for DAAs from payers and an appointment for MAT follow-up in a community clinic if indicated. Patient coordination; authorization with insurance companies; scheduling appointments, follow-up, and ancillary support services will be conducted by a Patient Navigator. Patients are seen every 2-4 weeks for monitoring and adherence support. HCV treatment regimens are at the discretion of the treating provider in accordance with AASLD/IDSA guidelines and insurance requirements. Twelve weeks after HCV therapy completion, SVR12 HCV RNA and SVR12 CMP tests will be obtained. |
| Simplified Care within a Mobile Medical Unit | Experimental | Other: Simplified HCV care within a mobile medical unitSimplified Care treatment is the same as for Usual Care with the exception that it is taking place within a mobile medical clinic that is scheduled to deliver treatment in alignment with regular syringe exchange services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Simplified HCV care within a mobile medical unitDelivers guideline-based care for HCV in a stream-lined manner on a mobile medical unit | Other | Simplified Care within a Mobile Medical Unit |
Primary outcome
Number of patients who initiate HCV treatment
Time frame: 6 months of follow-up
Initiating treatment with a Direct-Acting Antiviral (DAA)
6 secondary outcomes
Number of patients who complete HCV treatment
Time frame: 16 weeks after treatment initiation
SVR12 rates
Time frame: At least 12 weeks following DAA completion
Initiation rates for medication-assisted treatment (MAT) for Opioid Use Disorder
Time frame: During the first 3 months of follow-up after enrollment
Persistent rate for MAT
Time frame: During 6 months of follow-up after enrollment
Number of patients who receive abscess care
Time frame: During 6 months of follow-up after enrollment
Prevalence of engagement in care
Time frame: During 6 months of follow-up after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 40476033Ramers CB, Vawter N, Northrup A, Klaman SL, Lewis SV, Tam A, Del Aguila C, Lewis R, Mendez B, Reyes L, Matthews E, Rojas S, Godino JG. Simplified and Integrated Hepatitis C Virus Testing and Treatment Algorithm for Unhoused People Who Inject Drugs. Open Forum Infect Dis. 2025 May 22;12(6):ofaf302. doi: 10.1093/ofid/ofaf302. eCollection 2025 Jun.
- Derived from this study: PubMed 38238686Klaman SL, Godino JG, Northrup A, Lewis SV, Tam A, Carrillo C, Lewis R, Matthews E, Mendez B, Reyes L, Rojas S, Ramers C. Does a simplified algorithm and integrated HCV care model improve linkage to care, retention, and cure among people who inject drugs? A pragmatic quality improvement randomized controlled trial protocol. BMC Infect Dis. 2024 Jan 19;24(1):105. doi: 10.1186/s12879-024-08982-1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified HCV care within a mobile medical unit in people with Hepatitis C, run by Family Health Centers of San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients who initiate HCV treatment (time frame: 6 months of follow-up). 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 NCT04741750, which also lists 2 linked publications.
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 7 Feb 2024.