Testing of a Navigation Intervention for Hepatitis C and HIV

Not Applicable

Terminated

• Conditions: HIV (Human Immunodeficiency Virus); Hepatitis C
• Interventions: Behavioral: Navigation

• Registration Number: NCT04499651
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-07-28
• Study Start: 2020-07-31
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-05
• Status Verified: 2021-02
• Primary Completion: 2021-02-22
• Study Completion: 2021-02-22
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navigation	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

Primary Outcome Measures

Name	Time	Method
Undetectable Hepatitis C RNA	8 months	Undetectable Hepatitis C RNA
Undetectable HIV RNA	8 months	HIV RNA \<40 copies/ml

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States