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Testing of a Navigation Intervention for Hepatitis C and HIV (LINKHCV)

Primary Purpose

HIV (Human Immunodeficiency Virus), Hepatitis C

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Navigation
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV (Human Immunodeficiency Virus) focused on measuring HIV, Hepatitis C, Corrections, Engagement-in-care, Navigation, Criminal justice system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria (if recruited in jail)

  1. Diagnosed HIV+/HCV co-infection;
  2. 18 years of age or older;
  3. non-cis women;
  4. Fluent in speaking English;
  5. Have an anticipated sentence of no more than 12 months;
  6. Have detectable Hepatitis C viral load
  7. Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County

If recruited outside of jail:

  1. Diagnosed HIV+/HCV co-infection;
  2. 18 years of age or older;
  3. non-cis women;
  4. Fluent in speaking English;
  5. Incarceration history within the last 12 months of enrollment;
  6. Have detectable Hepatitis C viral load
  7. Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County

Exclusion Criteria:

  1. Inability to give informed consent
  2. CD4 count<200

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Navigation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Undetectable Hepatitis C RNA
Undetectable Hepatitis C RNA
Undetectable HIV RNA
HIV RNA <40 copies/ml

Secondary Outcome Measures

Full Information

First Posted
July 28, 2020
Last Updated
February 23, 2021
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04499651
Brief Title
Testing of a Navigation Intervention for Hepatitis C and HIV
Acronym
LINKHCV
Official Title
Adaptation and Testing of a Navigation Intervention for Hepatitis C and HIV Co-infected Persons Leaving LA County Jail
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment numbers due to Covid-19 pandemic
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV (Human Immunodeficiency Virus), Hepatitis C
Keywords
HIV, Hepatitis C, Corrections, Engagement-in-care, Navigation, Criminal justice system

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Navigation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Navigation
Intervention Description
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
Primary Outcome Measure Information:
Title
Undetectable Hepatitis C RNA
Description
Undetectable Hepatitis C RNA
Time Frame
8 months
Title
Undetectable HIV RNA
Description
HIV RNA <40 copies/ml
Time Frame
8 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
All cis-men (assigned "male" at birth) are eligible for the study regardless of current gender identification.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Goodman-Meza, MD, MAS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Debika Bhattacharya, MD, MSc
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Testing of a Navigation Intervention for Hepatitis C and HIV

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