NCT04499651

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

July 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

July 28, 2020

Last Update Submit

February 23, 2021

Conditions

HIV (Human Immunodeficiency Virus)Hepatitis C

Keywords

HIVHepatitis CCorrectionsEngagement-in-careNavigationCriminal justice system

Outcome Measures

Primary Outcomes (2)

  • Undetectable Hepatitis C RNA

    Undetectable Hepatitis C RNA

    8 months

  • Undetectable HIV RNA

    HIV RNA \<40 copies/ml

    8 months

Study Arms (2)

Control

NO INTERVENTION

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.

Navigation

ACTIVE COMPARATOR

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

Interventions

NavigationBEHAVIORAL

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

Navigation

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAll cis-men (assigned "male" at birth) are eligible for the study regardless of current gender identification.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed HIV+/HCV co-infection;
  • 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;
  • 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

You may not qualify if:

  • Inability to give informed consent
  • CD4 count\<200

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHepatitis C

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • David Goodman-Meza, MD, MAS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Debika Bhattacharya, MD, MSc

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 5, 2020

Study Start

July 31, 2020

Primary Completion

February 22, 2021

Study Completion

February 22, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

US(1)