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
|Condition or disease||Intervention/treatment||Phase|
|HIV (Human Immunodeficiency Virus) Hepatitis C||Behavioral: Navigation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|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|
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:
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
- Undetectable Hepatitis C RNA [ Time Frame: 8 months ]Undetectable Hepatitis C RNA
- Undetectable HIV RNA [ Time Frame: 8 months ]HIV RNA <40 copies/ml
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
|United States, California|
|Los Angeles, California, United States, 90024|
|Principal Investigator:||David Goodman-Meza, MD, MAS||University of California, Los Angeles|
|Principal Investigator:||Debika Bhattacharya, MD, MSc||University of California, Los Angeles|