Hepatitis C Virus (HCV) InfectionNCT04513899
Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
A study testing Community health worker (CHW)/ registered nurse (RN) [CHW/RN] in people with Hepatitis C Virus (HCV) Infection, run by University of California, Irvine at 7 sites in United States.
Trial summary
This randomized controlled trial (RCT) will test the efficacy of a Community Health Worker/Registered Nurse (CHW-RN) HCV intervention for homeless individuals, many who are also drug users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus (HCV) Infection
- What is being tested?
- Community health worker (CHW)/ registered nurse (RN) [CHW/RN]
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Oct 2020to 20 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently homeless. A homeless person is defined as anyone who spent the previous night in a public or private shelter, a place not meant for sleeping (van, car, public facility, abandoned building) or in outdoor areas.
- age 18 or older;
- willing and able to provide informed consent;
- able to complete the screener;
- willing to have blood tests to be screened for HCV and tested HCV antibody positive;
- APRI ≤ 0.7, no signs of advanced cirrhosis (jaundice, ascites, encephalopathy) and willing to undergo the abdominal US as the standard of care (at the clinic).
- history of substance use (past 5 years).
Who cannot join
- current ongoing treatment for HCV;
- current HBV infection;
- HIV infection and not receiving medications for HIV treatment;
- not speaking English or Spanish; and
- testing pregnant; and
- judged to be cognitively impaired
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Amity Foundation, Los Angeles
Los Angeles, California, 90007
Cardinal Manning Center, Los Angeles
Los Angeles, California, 90013
Downtown Women Center, Los Angeles
Los Angeles, California, 90013
Los Angeles Christian Health Centers (LACHC)
Los Angeles, California, 90013
Union Rescue Mission
Los Angeles, California, 90013
Weingart Center, Los Angeles
Los Angeles, California, 90013
St. John's Well Child and Family Center (SJWCFC), PRIME Specialty Clinic
Los Angeles, California, 90037
About this study
This randomized controlled trial (RCT) will test the efficacy of a Community Health Worker/Registered Nurse (CHW-RN) HCV intervention for homeless individuals, many who are also drug users. The intervention will be designed during Phase I of the proposal using an iterative process between a Community Advisory Board (CAB) and focus groups. The CHW/RN intervention will occur over a 2 or 3 month (8-12 weeks) period depending on the Direct-Acting Antiviral (DAA) prescribed. Homeless adults assigned to the CHW/RN HCV treatment group will receive culturally-sensitive education, case management, and daily DOT delivery of DAA by an RN-guided CHW. The CHW will run a brief (20 min) weekly 1:1 education and 20 min case management session over the 8 or 12 weeks and will deliver all components of the program (which will be developed and refined during Phase I). The CHW-RN HCV intervention will be compared to a clinic-based standard of care group (cbSOC). Primary outcomes are the completion of the Direct-Acting Agent (DAA) treatment (month 2 or 3) and SVR12 Cure (month 5 or 6). Secondary outcomes are improved mental health status, decrease in substance use, and improved access to health care, and shelter stability at month 5 or 6.
Read the detailed description
HCV infection disproportionately affects homeless and drug-using populations and represents a critical focus for effective HCV prevention at the individual and community level. Homeless persons have a 26 fold increase in HCV prevalence compared to the general population; particularly with injection drug use (IDU). In fact, 50-80% of HCV infection is among persons who inject drugs (PWID). Among homeless populations, risk factors for HCV include older age, IDU, needle sharing, previous incarceration, veteran status, fair-or-poor health status, and sharing toothbrushes. Among the 48% of HCV-infected homeless persons who did not inject drugs, correlates of HCV infection include older age, less education, use of drugs, and history of multiple tattoos. While HCV treatment for PWID can reduce HCV prevalence, despite recommended guidelines, only 1-6% of drug-using HCV-infected persons have received treatment. Among the homeless adults, factors associated with low HCV treatment completion include untreated mental illness, current substance use, unstable housing, and limited access to care. Although the new Direct Acting Agent (DAA) are costly, cure rates have risen to above 98%. Yet limited research has been conducted on DAA agents among drug-using homeless adults. Extending HCV treatment beyond the traditional tertiary care model and involving peer supports can facilitate access to HCV treatment. The scientific premise of this proposal is that homeless HCV positive adults often do not obtain/complete HCV treatment due to significant psychosocial barriers. Thus, developing and testing a strategy that combines treatment with psychosocial support would be expected to change this outcome. To our knowledge, no randomized controlled trial (RCT) has yet assessed the efficacy of a comprehensive community-based model that incorporates HCV and substance use treatment to address HCV among homeless persons, despite the critical need that exists. The proposed treatment concept - Community Health Worker/Registered Nurse (CHW-RN) - is innovative and helps HCV treatment reach beyond the clinic walls, directly into the community where the homeless reside, reducing barriers to treatment. Guided by our community-based model, the CHW/RN intervention will focus on improving social support, coping skills, problem-solving, self-management, physical and mental health, substance use, and stable housing.
The proposed study will contribute to our knowledge about culturally-sensitive strategies for HCV treatment among homeless adults, many of whom use drugs and alcohol. It will address a substantial health disparity in a historically underserved population, with broader implications for public health. While DAAs have not been assessed among homeless adults using RCTs, homeless persons who are active drug users, in particular, have had challenges with uptake and compliance of other HCV treatments. To our knowledge, no study has evaluated the effect of a CHW/RN HCV treatment program, delivered in the community where the participant lives, compared to a cbSOC model to assess HCV treatment completion and Sustained Virologic Response (SVR) after 12 weeks of treatment completion. For further innovation, we will now evaluate the extent to which the pathways posed by the CHSCP and similar models, including the BMVP affect health outcomes by adding to Aim 3 analyses an examination of mechanisms of therapeutic change by the mediating effects of improved psychosocial and structural factors (e.g. housing, social support, etc ) on improved rates of SVR12. Improved understanding of the mechanisms of effect will advance the understanding of these factors and their role in determining health outcomes. The proposed study will pretest an RN-guided, CHW-delivered, program wherein a CHW/RN program will be developed and pretested with the community through focus group methodology. The intervention will focus on improving the completion of HCV treatment, reducing drug and alcohol use, reducing mental illness, and improving housing stability. The findings of this study can lay the groundwork for a subsequent larger trial to test the efficacy of the developed CHW/RN program more broadly and may inform health policy that could encourage enrollment of this high-risk group into HCV treatment. Results may also inform future cost-effective, community-based interventions that could be scaled-up and disseminated more broadly. Employing a treatment-as-prevention focus of HCV transmission in the community is urgent since HCV among the homeless represents a reservoir for HCV infection in the general population.
- Conditions
- Hepatitis C Virus (HCV) Infection
- Being tested
- Community health worker (CHW)/ registered nurse (RN) [CHW/RN], Clinic-based Standard of Care (cbSOC) Program (control group)
- Medical subject headings
- Hepatitis C, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health worker (CHW)/ registered nurse (RN) [CHW/RN]Behavioural
A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
Clinic-based Standard of Care (cbSOC) Program (control group)Behavioural
This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker/Registered Nurse (CHW/RN) | Experimental | Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment. Receives: Behavioral: Community health worker (CHW)/ registered nurse (RN) [CHW/RN] |
| Clinic-based Standard of Care (cbSOC) | Active comparator | Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site Receives: Behavioral: Clinic-based Standard of Care (cbSOC) Program (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing HCV Treatment
The number of participants completing HCV treatment (7 days per week x 2- or 3 month treatment of DAA) was measured by pill count to measure adherence in both groups. For the RN/CHW group, directly observed therapy was utilized where the CHW or RN delivered the medication daily and documented each time s/he observed the participant swallow a pill.
For the cbSOC Program (control group), the clinic-based MD/NP conducted a pill count monthly, based on the medications left in the pill bottle each month the participant is scheduled to pick up the next supply
Measured: 2-3 months depending on which DAA drug was provided. Some required 2 months and others, 3 months.
Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion)
The number of participants who attained SVR12 Cure (HCV RNA < 25 IU/ml, detectable or undetectable) as tested at 5 or 6-month follow-up (12 weeks after treatment completion)
Measured: 5 or 6 months
Secondary outcomes (6)
Drug Use
Assessed by drug items in the Texas Christian University (TCU) Screen V. Yes/No responses to substance dependency questions and the frequency of drug use based on a 5-point scale from 1 (never) to 5 (daily) was assessed for each drug used. The range of scores on the 11-item Yes/no questions analyzed ranged from ranges from 0 - 11; corresponding to the number of symptoms endorsed by the participant and the severity of SUD: Mild disorder (2-3 points), moderate disorder (4-5 points), or severe disorder (6 or more points). The total score was calculated by adding the scores for all questions and averaging for all the participants at each follow-up time point. Drug Use was assessed at "2 or 3" months and "5 or 6" months follow-up.
Measured: 2 or 3- and 5 or 6-month follow-up
Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Assessed by a brief alcohol screening instrument The Alcohol Use Disorders Identification Test-Concise (AUDIT-C). AUDIT-C reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. The higher the score the more severe is the alcohol disorder. The total score was calculated by adding the scores for all questions and averaging for all the participants at each follow-up time point Based on the duration of DAA prescribed for the HCV treatment, the follow-up period was at "2 or 3" months and "5 or 6" months.
Measured: Assessment at 2 or 3- and 5 or 6-month follow-up
CAGE Substance Abuse Screening Scale
Assessed by CAGE an internationally used assessment instrument for identifying alcoholics. Item responses on the CAGE are scored 0 or 1. The total score was calculated by adding up the scores for all four questions and averaging for all the participants for each time point. A total score of 2 or greater is considered clinically significant and may indicate alcohol-related issues.
Based on the duration of DAA prescribed for the HCV treatment, the follow-up period was at "2 or 3" months and "5 or 6" months.
Measured: 2 or 3- and 5 or 6-month follow-up
Depression
Mental Health will be assessed by Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a self-administered depression module of the Patient Health Questionnaire (PHQ). It contains 9 questions that help identify patients with clinically meaningful symptoms of depression. Patient responses are scored 0-3 with 0 representing "not at all" and 3 indicating "nearly every day;" thus, the PHQ-9 contains a total score range of 0-27. The total score was calculated by adding the scores for all questions and averaging for all the participants at each follow-up time point. The higher the score, the more severe is the alcohol disorder.
Based on the duration of DAA prescribed for the HCV treatment, the follow-up period was at "2 or 3" months and "5 or 6" months.
Measured: 2 or 3- and 5 or 6-month follow-up
Mental Health
Mental Health was assessed by the Mental Health Inventory (MHI)-5; well-demonstrated reliability for detecting psychological disorders. The MHI-5 comprises five questions. There are six possible responses to the questions, scored between 1 and 6. The score for each individual therefore ranges between 5 and 30. This is then transformed into a variable ranging from 0-100 using a standard linear transformation. The higher the score, the better the perception of mental health.
Based on the duration of DAA prescribed for the HCV treatment, the follow-up period was at "2 or 3" months and "5 or 6" months.
Measured: 2 or 3- and 5 or 6-month follow-up
Health Care Access
Health Care Access will include number of participants who completed 2 or more visits for health care or social services during the 2-3 month and 5-6 month follow-up
Measured: 2 or 3- and 5 or 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start5 Oct 2020
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
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 (HCV) InfectionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Adeline Nyamathi, University of California, Irvine
- Investigators
- ADELINE M NYAMATHI, PhD, Principal investigator, University of California, IrvineLillian Gelberg, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513899
- Sponsor's protocol ID
- 2020-5832
- Other IDs
- R21MD013580
- Status last verified
- Feb 2024
- First submitted
- 5 Aug 2020
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nyamathi A, Salem BE, Lee D, Yu Z, Hudson A, Saab S, Shin SS, Jones-Patten A, Yadav K, Alikhani M, Clarke R, Chang A, White K, Gelberg L. Exploratory assessment: Nurse-led community health worker delivered HCV intervention for people experiencing homelessness. Public Health Nurs. 2023 Sep-Oct;40(5):641-654. doi: 10.1111/phn.13204. Epub 2023 May 2.
PubMed 37132164
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
- ClinicalTrials.gov ID
- NCT04513899
- Acronym / sponsor ID
- 2020-5832
- Conditions
- Hepatitis C Virus (HCV) Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial (RCT) will test the efficacy of a Community Health Worker/Registered Nurse (CHW-RN) HCV intervention for homeless individuals, many who are also drug users. The intervention will be designed during Phase I of the proposal using an iterative process between a Community Advisory Board (CAB) and focus groups. The CHW/RN intervention will occur over a 2 or 3 month (8-12 weeks) period depending on the Direct-Acting Antiviral (DAA) prescribed. Homeless adults assigned to the CHW/RN HCV treatment group will receive culturally-sensitive education, case management, and daily DOT delivery of DAA by an RN-guided CHW. The CHW will run a brief (20 min) weekly 1:1 education and 20 min case management session over the 8 or 12 weeks and will deliver all components of the program (which will be developed and refined during Phase I). The CHW-RN HCV intervention will be compared to a clinic-based standard of care group (cbSOC). Primary outcomes are the completion of the Direct-Acting Agent (DAA) treatment (month 2 or 3) and SVR12 Cure (month 5 or 6). Secondary outcomes are improved mental health status, decrease in substance use, and improved access to health care, and shelter stability at month 5 or 6.
Detailed description
HCV infection disproportionately affects homeless and drug-using populations and represents a critical focus for effective HCV prevention at the individual and community level. Homeless persons have a 26 fold increase in HCV prevalence compared to the general population; particularly with injection drug use (IDU). In fact, 50-80% of HCV infection is among persons who inject drugs (PWID). Among homeless populations, risk factors for HCV include older age, IDU, needle sharing, previous incarceration, veteran status, fair-or-poor health status, and sharing toothbrushes. Among the 48% of HCV-infected homeless persons who did not inject drugs, correlates of HCV infection include older age, less education, use of drugs, and history of multiple tattoos. While HCV treatment for PWID can reduce HCV prevalence, despite recommended guidelines, only 1-6% of drug-using HCV-infected persons have received treatment. Among the homeless adults, factors associated with low HCV treatment completion include untreated mental illness, current substance use, unstable housing, and limited access to care. Although the new Direct Acting Agent (DAA) are costly, cure rates have risen to above 98%. Yet limited research has been conducted on DAA agents among drug-using homeless adults. Extending HCV treatment beyond the traditional tertiary care model and involving peer supports can facilitate access to HCV treatment. The scientific premise of this proposal is that homeless HCV positive adults often do not obtain/complete HCV treatment due to significant psychosocial barriers. Thus, developing and testing a strategy that combines treatment with psychosocial support would be expected to change this outcome. To our knowledge, no randomized controlled trial (RCT) has yet assessed the efficacy of a comprehensive community-based model that incorporates HCV and substance use treatment to address HCV among homeless persons, despite the critical need that exists. The proposed treatment concept - Community Health Worker/Registered Nurse (CHW-RN) - is innovative and helps HCV treatment reach beyond the clinic walls, directly into the community where the homeless reside, reducing barriers to treatment. Guided by our community-based model, the CHW/RN intervention will focus on improving social support, coping skills, problem-solving, self-management, physical and mental health, substance use, and stable housing.
The proposed study will contribute to our knowledge about culturally-sensitive strategies for HCV treatment among homeless adults, many of whom use drugs and alcohol. It will address a substantial health disparity in a historically underserved population, with broader implications for public health. While DAAs have not been assessed among homeless adults using RCTs, homeless persons who are active drug users, in particular, have had challenges with uptake and compliance of other HCV treatments. To our knowledge, no study has evaluated the effect of a CHW/RN HCV treatment program, delivered in the community where the participant lives, compared to a cbSOC model to assess HCV treatment completion and Sustained Virologic Response (SVR) after 12 weeks of treatment completion. For further innovation, we will now evaluate the extent to which the pathways posed by the CHSCP and similar models, including the BMVP affect health outcomes by adding to Aim 3 analyses an examination of mechanisms of therapeutic change by the mediating effects of improved psychosocial and structural factors (e.g. housing, social support, etc ) on improved rates of SVR12. Improved understanding of the mechanisms of effect will advance the understanding of these factors and their role in determining health outcomes. The proposed study will pretest an RN-guided, CHW-delivered, program wherein a CHW/RN program will be developed and pretested with the community through focus group methodology. The intervention will focus on improving the completion of HCV treatment, reducing drug and alcohol use, reducing mental illness, and improving housing stability. The findings of this study can lay the groundwork for a subsequent larger trial to test the efficacy of the developed CHW/RN program more broadly and may inform health policy that could encourage enrollment of this high-risk group into HCV treatment. Results may also inform future cost-effective, community-based interventions that could be scaled-up and disseminated more broadly. Employing a treatment-as-prevention focus of HCV transmission in the community is urgent since HCV among the homeless represents a reservoir for HCV infection in the general population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker/Registered Nurse (CHW/RN) | Experimental | Behavioral: Community health worker (CHW)/ registered nurse (RN) [CHW/RN]Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment. |
| Clinic-based Standard of Care (cbSOC) | Active comparator | Behavioral: Clinic-based Standard of Care (cbSOC) Program (control group)Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- currently homeless. A homeless person is defined as anyone who spent the previous night in a public or private shelter, a place not meant for sleeping (van, car, public facility, abandoned building) or in outdoor areas.
- age 18 or older;
- willing and able to provide informed consent;
- able to complete the screener;
- willing to have blood tests to be screened for HCV and tested HCV antibody positive;
Key exclusion criteria (6 listed)
- current ongoing treatment for HCV;
- current HBV infection;
- HIV infection and not receiving medications for HIV treatment;
- not speaking English or Spanish; and
- testing pregnant; and
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 |
|---|---|---|
| Community health worker (CHW)/ registered nurse (RN) [CHW/RN]A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments. | Behavioural | Community Health Worker/Registered Nurse (CHW/RN) |
| Clinic-based Standard of Care (cbSOC) Program (control group)This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP. | Behavioural | Clinic-based Standard of Care (cbSOC) |
Primary outcome
Number of Participants Completing HCV Treatment
Time frame: 2-3 months depending on which DAA drug was provided. Some required 2 months and others, 3 months.
The number of participants completing HCV treatment (7 days per week x 2- or 3 month treatment of DAA) was measured by pill count to measure adherence in both groups. For the RN/CHW group, directly observed therapy was utilized where the CHW or RN delivered the medication daily and documented each time s/he observed the participant swallow a pill. For the cbSOC Program (control group), the clinic-based MD/NP conducted a pill count monthly, based on the medications left in the pill bottle each month the participant is scheduled to pick up the next supply
Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion)
Time frame: 5 or 6 months
The number of participants who attained SVR12 Cure (HCV RNA < 25 IU/ml, detectable or undetectable) as tested at 5 or 6-month follow-up (12 weeks after treatment completion)
6 secondary outcomes
Drug Use
Time frame: 2 or 3- and 5 or 6-month follow-up
Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Time frame: Assessment at 2 or 3- and 5 or 6-month follow-up
CAGE Substance Abuse Screening Scale
Time frame: 2 or 3- and 5 or 6-month follow-up
Depression
Time frame: 2 or 3- and 5 or 6-month follow-up
Mental Health
Time frame: 2 or 3- and 5 or 6-month follow-up
Health Care Access
Time frame: 2 or 3- and 5 or 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37132164Nyamathi A, Salem BE, Lee D, Yu Z, Hudson A, Saab S, Shin SS, Jones-Patten A, Yadav K, Alikhani M, Clarke R, Chang A, White K, Gelberg L. Exploratory assessment: Nurse-led community health worker delivered HCV intervention for people experiencing homelessness. Public Health Nurs. 2023 Sep-Oct;40(5):641-654. doi: 10.1111/phn.13204. Epub 2023 May 2.
- Individual participant dataSharing planned: Undecided
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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.
ADELINE M NYAMATHI, PhD principal investigator
University of California, Irvine
Lillian Gelberg, MD principal investigator
University of California, Los Angeles
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community health worker (CHW)/ registered nurse (RN) [CHW/RN] in people with Hepatitis C Virus (HCV) Infection, run by University of California, Irvine at 7 sites 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?
The sponsor lists 7 inclusion and 6 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 1 Mar 2024). 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?
Number of Participants Completing HCV Treatment (time frame: 2-3 months depending on which DAA drug was provided. Some required 2 months and others, 3 months.). The study lists 2 primary outcomes in all. 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 NCT04513899, 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 1 Mar 2024.