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

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ClinicalTrials.gov Identifier: NCT04499651
Recruitment Status : Terminated (Insufficient enrollment numbers due to Covid-19 pandemic)
First Posted : August 5, 2020
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
David Goodman-Meza, MD, University of California, Los Angeles

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 31, 2020
Actual Primary Completion Date : February 22, 2021
Actual Study Completion Date : February 22, 2021

Resource links provided by the National Library of Medicine


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:

  1. Session 1: Intervention Overview and Basic HIV/HCV Knowledge and Skills Builder
  2. Session 2: Rapport Building
  3. Session 3: Society and Self and the Role of Disclosure
  4. Session 4: Accompaniment 1
  5. Session 5: Goal-Setting, Problem-Solving and a Disclosure Toolkit
  6. Session 6: Accompaniment 2
  7. Session 7: Accompaniment 3 (ONLY if needed)
  8. 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




Primary Outcome Measures :
  1. Undetectable Hepatitis C RNA [ Time Frame: 8 months ]
    Undetectable Hepatitis C RNA

  2. Undetectable HIV RNA [ Time Frame: 8 months ]
    HIV RNA <40 copies/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All cis-men (assigned "male" at birth) are eligible for the study regardless of current gender identification.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499651


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: David Goodman-Meza, MD, MAS University of California, Los Angeles
Principal Investigator: Debika Bhattacharya, MD, MSc University of California, Los Angeles
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Responsible Party: David Goodman-Meza, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04499651    
Other Study ID Numbers: ISR-US-18-10586
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Goodman-Meza, MD, University of California, Los Angeles:
HIV
Hepatitis C
Corrections
Engagement-in-care
Navigation
Criminal justice system
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases