HIV (Human Immunodeficiency Virus)LINKHCVNCT04499651
Testing of a Navigation Intervention for Hepatitis C and HIV
A study testing Navigation in people with HIV (Human Immunodeficiency Virus) and Hepatitis C, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Hepatitis C
- What is being tested?
- Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2020to 22 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed HIV+/HCV co-infection;
- 18 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
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- 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;
- 18 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
Who cannot join
- Inability to give informed consent
- CD4 count<200
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Testing of a Navigation Intervention for Hepatitis C and HIV Co-infected Persons Leaving LA County Jail
This study will evaluate the efficacy of navigation for hepatitis C treatment in people living with both HIV and HCV with criminal justice involvement.
Read the 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.
- Conditions
- HIV (Human Immunodeficiency Virus), Hepatitis C
- Being tested
- Navigation
- Keywords
- HIV, Hepatitis C, Corrections, Engagement-in-care, Navigation, Criminal justice system
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable Hepatitis C RNA
Undetectable Hepatitis C RNA
Measured: 8 months
Undetectable HIV RNA
HIV RNA <40 copies/ml
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start31 Jul 2020
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Why it stopped: Insufficient enrollment numbers due to Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Goodman-Meza, MD, University of California, Los Angeles
- Investigators
- David Goodman-Meza, MD, MAS, Principal investigator, University of California, Los AngelesDebika Bhattacharya, MD, MSc, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499651
- Sponsor's protocol ID
- ISR-US-18-10586
- Acronym
- LINKHCV
- Status last verified
- Feb 2021
- First submitted
- 28 Jul 2020
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Testing of a Navigation Intervention for Hepatitis C and HIV Co-infected Persons Leaving LA County Jail
- ClinicalTrials.gov ID
- NCT04499651
- Acronym / sponsor ID
- LINKHCV / ISR-US-18-10586
- Conditions
- HIV (Human Immunodeficiency Virus), Hepatitis C
- Keywords
- HIV, Hepatitis C, Corrections, Engagement-in-care, Navigation, Criminal justice system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment numbers due to Covid-19 pandemic
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: NavigationParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosed HIV+/HCV co-infection;
- 18 years of age or older;
- non-cis women;
- Fluent in speaking English;
- Have an anticipated sentence of no more than 12 months;
Key exclusion criteria (2 listed)
- Inability to give informed consent
- CD4 count<200
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavigationTrained 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 | Behavioural | Navigation |
Primary outcome
Undetectable Hepatitis C RNA
Time frame: 8 months
Undetectable Hepatitis C RNA
Undetectable HIV RNA
Time frame: 8 months
HIV RNA <40 copies/ml
Results and safety
The study was stopped early (reason given: Insufficient enrollment numbers due to Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Goodman-Meza, MD, MAS principal investigator
University of California, Los Angeles
Debika Bhattacharya, MD, MSc principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation in people with HIV (Human Immunodeficiency Virus) and Hepatitis C, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment numbers due to Covid-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable Hepatitis C RNA (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.