Clinical trial NCT04513899: Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
Official title: Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C Virus (HCV) Infection
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Completing HCV Treatment
timeFrame: 2-3 months depending on which DAA drug was provided. Some required 2 months and others, 3 months.
measure: Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion)
timeFrame: 5 or 6 months
Secondary outcomes:
measure: Drug Use
timeFrame: 2 or 3- and 5 or 6-month follow-up
measure: Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
timeFrame: Assessment at 2 or 3- and 5 or 6-month follow-up
measure: CAGE Substance Abuse Screening Scale
timeFrame: 2 or 3- and 5 or 6-month follow-up
measure: Depression
timeFrame: 2 or 3- and 5 or 6-month follow-up
measure: Mental Health
timeFrame: 2 or 3- and 5 or 6-month follow-up
measure: Health Care Access
timeFrame: 2 or 3- and 5 or 6-month follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Amity Foundation, Los Angeles
state: California
city: Los Angeles
country: United States
facility: Cardinal Manning Center, Los Angeles
state: California
city: Los Angeles
country: United States
facility: Downtown Women Center, Los Angeles
state: California
city: Los Angeles
country: United States
facility: Los Angeles Christian Health Centers (LACHC)
state: California
city: Los Angeles
country: United States
facility: Union Rescue Mission
state: California
city: Los Angeles
country: United States
facility: Weingart Center, Los Angeles
state: California
city: Los Angeles
country: United States
facility: St. John's Well Child and Family Center (SJWCFC), PRIME Specialty Clinic
state: California
Study officials:
affiliation: University of California, Irvine
name: ADELINE M NYAMATHI, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Lillian Gelberg, MD
role: PRINCIPAL_INVESTIGATOR
References: