Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04513899

Enrollment

Registered

2020-08-14

Start date

2020-10-05

Completion date

2022-07-20

Last updated

2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus (HCV) Infection

Brief 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. 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.

Interventions

BEHAVIORALCommunity 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.

BEHAVIORALClinic-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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).

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Completing HCV Treatment	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)	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)

Secondary

Measure	Time frame	Description
CAGE Substance Abuse Screening Scale	2 or 3- and 5 or 6-month follow-up	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.
Depression	2 or 3- and 5 or 6-month follow-up	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.
Drug Use	2 or 3- and 5 or 6-month follow-up	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.
Health Care Access	2 or 3- and 5 or 6-month follow-up	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
Mental Health	2 or 3- and 5 or 6-month follow-up	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.
Alcohol Use Disorders Identification Test-Concise (AUDIT-C)	Assessment at 2 or 3- and 5 or 6-month follow-up	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.

Countries

United States

Participant flow

Recruitment details

Based on our protocol, after screening was conducted, all eligible participants (n = 10) were enrolled over the length of the study, and after informed consent was completed.

Participants by arm

Arm	Count
Community Health Worker/Registered Nurse (CHW/RN) Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment. 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.	4
Clinic-based Standard of Care (cbSOC) Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site 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.	6
Total	10

Baseline characteristics

Characteristic	Community Health Worker/Registered Nurse (CHW/RN)	Total	Clinic-based Standard of Care (cbSOC)
Age, Continuous	49.8 years STANDARD_DEVIATION 6.75	53.3 years STANDARD_DEVIATION 9.02	55.7 years STANDARD_DEVIATION 10.1
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	6 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants	4 Participants	3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	4 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	3 Participants	2 Participants
Race (NIH/OMB) White	2 Participants	3 Participants	1 Participants
Region of Enrollment United States	4 participants	10 participants	6 participants
Sex: Female, Male Female	1 Participants	2 Participants	1 Participants
Sex: Female, Male Male	3 Participants	8 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 4	0 / 6
other Total, other adverse events	3 / 4	0 / 0
serious Total, serious adverse events	0 / 4	0 / 6

Outcome results

Primary

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)

Time frame: 5 or 6 months

Population: All randomized participants

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Community Health Worker/Registered Nurse (CHW/RN)	Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion)	3 Participants
Clinic-based Standard of Care (cbSOC)	Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion)	4 Participants

Primary

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

Time frame: 2-3 months depending on which DAA drug was provided. Some required 2 months and others, 3 months.

Population: All randomized participants

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Community Health Worker/Registered Nurse (CHW/RN)	Number of Participants Completing HCV Treatment	3 Participants
Clinic-based Standard of Care (cbSOC)	Number of Participants Completing HCV Treatment	6 Participants

Secondary

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.

Time frame: Assessment at 2 or 3- and 5 or 6-month follow-up

Population: Complete case

Arm	Measure	Group	Value (MEAN)	Dispersion
Community Health Worker/Registered Nurse (CHW/RN)	Alcohol Use Disorders Identification Test-Concise (AUDIT-C)	2 or 3 month follow up	1.5 score on a scale	Standard Deviation 2.12
Community Health Worker/Registered Nurse (CHW/RN)	Alcohol Use Disorders Identification Test-Concise (AUDIT-C)	5 or 6 month follow up	0.33 score on a scale	Standard Deviation 0.58
Clinic-based Standard of Care (cbSOC)	Alcohol Use Disorders Identification Test-Concise (AUDIT-C)	2 or 3 month follow up	2.8 score on a scale	Standard Deviation 3.03
Clinic-based Standard of Care (cbSOC)	Alcohol Use Disorders Identification Test-Concise (AUDIT-C)	5 or 6 month follow up	3.6 score on a scale	Standard Deviation 4.8

Secondary

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.