Clinical trial NCT04499651: Testing of a Navigation Intervention for Hepatitis C and HIV
Official title: Adaptation and Testing of a Navigation Intervention for Hepatitis C and HIV Co-infected Persons Leaving LA County Jail
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Hepatitis C
Keywords: HIV
Hepatitis C
Corrections
Engagement-in-care
Navigation
Criminal justice system
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Undetectable Hepatitis C RNA
timeFrame: 8 months
measure: Undetectable HIV RNA
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: David Goodman-Meza, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Debika Bhattacharya, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: