LINKHCV: Testing of a Navigation Intervention for Hepatitis C and HIV

Sponsor

University of California, Los Angeles (Other)

Overall Status

Terminated

CT.gov ID

NCT04499651

Collaborator

(none)

Enrollment

Location

Arms

6.8

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy of navigation for hepatitis C treatment in people living with both HIV and HCV with criminal justice involvement.

Condition or Disease	Intervention/Treatment	Phase
HIV (Human Immunodeficiency Virus) Hepatitis C	Behavioral: Navigation	N/A

Detailed Description

Hepatitis C (HCV) is the most common chronic, blood-borne infection in the U.S. and, untreated, can result in liver failure and liver cancer. Despite advances in treatment and remarkable improvements in cure rates, very few persons with chronic HCV infection are receiving this treatment, especially among people who use drugs, who are also disproportionately HIV-infected and incarcerated. Existing efforts to ensure linkage to and retention in medical care following release from incarceration among people living with both HIV and HCV are generally insufficient. Increasing treatment engagement following release from incarceration can drastically reduce HCV and HIV in the blood, which can limit transmission to sexual and injection drug use partners.

The goal of this study is to evaluate the effect of a novel navigation intervention to improve HIV/HCV treatment engagement among HIV/HCV co-infected adults with criminal justice involvement. The investigators hypothesize that the navigation intervention is more effective than the current standard-of-care approaches to link this population of adults to HIV/HCV treatment. All participants, regardless of study arm, will complete one baseline interview around the time of study enrollment. Follow-up interviews are done at 3 months and 8 months following enrollment (if enrolled in the community) or after release from jail (if enrolled in the jail).

Blood samples to analyze the HCV RNA will be collected or requested from participants' clinics both for the baseline assessment and the assessment conducted 12 weeks after completion of the HCV treatment course (if the HCV RNA result cannot be obtained at 12 weeks, it will done at the 8-month follow-up interview). HIV RNA will be collected from the clinics.

In addition to the interviews and the HCV/HIV RNA assessments, participants assigned to the intervention arm will engage in a six- or seven-session navigation intervention. Participants will be in the study for about 12 months but no more than 3 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Adaptation and Testing of a Navigation Intervention for Hepatitis C and HIV Co-infected Persons Leaving LA County Jail

Actual Study Start Date :

Jul 31, 2020

Actual Primary Completion Date :

Feb 22, 2021

Actual Study Completion Date :

Feb 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control All people who are living with HIV who are currently in custody in the Los Angeles County Jail are provided with Transitional Case Management and may also receive Whole Person Care related services regardless of participation in this study. Participants recruited from clinics who do not enroll in the study will be offered HIV/HCV care that follows the national HIV/HCV care guidelines, as provided by participating study clinics. Participants recruited from non-medical community agencies who do not enroll in the study and do not have a regular provider will receive a referral list of HIV/HCV care facilities that follow the national HIV/HCV care guidelines.
Active Comparator: Navigation Participants will be paired with a navigator and will complete the following didactic sessions in one-on-one format: Session 1: Intervention Overview and Basic HIV/HCV Knowledge and Skills Builder Session 2: Rapport Building Session 3: Society and Self and the Role of Disclosure Session 4: Accompaniment 1 Session 5: Goal-Setting, Problem-Solving and a Disclosure Toolkit Session 6: Accompaniment 2 Session 7: Accompaniment 3 (ONLY if needed) Weekly check-in calls following Session 2 for six months	Behavioral: Navigation Trained study navigators will provide one-on-one learning sessions and accompaniments to criminal-justice involved people to help link them to HIV/Hepatitis C care

Arm

Intervention/Treatment

No Intervention: Control

All people who are living with HIV who are currently in custody in the Los Angeles County Jail are provided with Transitional Case Management and may also receive Whole Person Care related services regardless of participation in this study. Participants recruited from clinics who do not enroll in the study will be offered HIV/HCV care that follows the national HIV/HCV care guidelines, as provided by participating study clinics. Participants recruited from non-medical community agencies who do not enroll in the study and do not have a regular provider will receive a referral list of HIV/HCV care facilities that follow the national HIV/HCV care guidelines.

Active Comparator: Navigation

Participants will be paired with a navigator and will complete the following didactic sessions in one-on-one format: Session 1: Intervention Overview and Basic HIV/HCV Knowledge and Skills Builder Session 2: Rapport Building Session 3: Society and Self and the Role of Disclosure Session 4: Accompaniment 1 Session 5: Goal-Setting, Problem-Solving and a Disclosure Toolkit Session 6: Accompaniment 2 Session 7: Accompaniment 3 (ONLY if needed) Weekly check-in calls following Session 2 for six months

Behavioral: Navigation

Trained study navigators will provide one-on-one learning sessions and accompaniments to criminal-justice involved people to help link them to HIV/Hepatitis C care

Outcome Measures

Primary Outcome Measures

Undetectable Hepatitis C RNA [8 months]
Undetectable Hepatitis C RNA
Undetectable HIV RNA [8 months]
HIV RNA <40 copies/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria (if recruited in jail)

Diagnosed HIV+/HCV co-infection;
18 years of age or older;
non-cis women;
Fluent in speaking English;
Have an anticipated sentence of no more than 12 months;
Have detectable Hepatitis C viral load
Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County

If recruited outside of jail:

Diagnosed HIV+/HCV co-infection;
18 years of age or older;
non-cis women;
Fluent in speaking English;
Incarceration history within the last 12 months of enrollment;
Have detectable Hepatitis C viral load
Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County

Exclusion Criteria:

Inability to give informed consent
CD4 count<200

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90024

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator: David Goodman-Meza, MD, MAS, University of California, Los Angeles
Principal Investigator: Debika Bhattacharya, MD, MSc, University of California, Los Angeles