Clinical trial NCT02641158: Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.
Official title: CTN 0064: Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
HIV
AIDS
Substance Use
Keywords: HIV
Hepatitis C
Substance users
Drug users
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Jackson Health System
name: Grady Memorial Hospital
name: St. Luke's-Roosevelt Hospital Center
name: University of Texas
name: Johns Hopkins University
name: University Hospital Birmingham
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: University of Pittsburgh Medical Center
name: Hahnemann University Hospital
name: Cook County Health
name: Boston University
name: Weill Medical College of Cornell University
name: Icahn School of Medicine at Mount Sinai
name: The Emmes Company, LLC
name: University of Miami
name: University of California, San Francisco
First posted: 2015-12-29
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group).

Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period.

Secondary Objectives:

Component 1 (Long-term CTN 0049 follow-up):

Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions:

1. HIV virological suppression
2. HIV primary care visit attendance
3. All-cause mortality

Detailed description: The CTN 0064 study leverages the existing research infrastructure and cohort of the CTN 0049 (NCT01612169) randomized, controlled trial (RCT). CTN 0049 ("Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users") is a three-group RCT that evaluated the most effective strategy to achieve HIV virologic suppression among HIV-infected substance users who were recruited from hospital settings. Between July 2012 and January 2014, a total of 801 HIV-infected hospitalized patients were recruited from 11 participating sites throughout the U.S. and randomized to one of the following three groups: 1) Patient Navigator intervention, 2) Patient Navigator plus Contingency Management intervention, and 3) Treatment as Usual. All CTN 0049 participants provided informed consent and completed baseline computer assisted personal interviews or CAPI (computer assisted personal interview: focusing on drug use, mental health, demographics and socio-economic factors, HIV care and drug treatment history) and blood draws (for HIV viral load and CD4 count). The two intervention groups received up to 11 patient navigation sessions over a 6-month period to actively assist participants in linking to HIV primary care and substance use treatment. Participants in all three groups completed follow-up assessments consisting of CAPI, blood draws, urine collection and breath analysis at approximately 6 and 12 months post-randomization. Medical records were reviewed to document receipt of HIV care and treatment during the study period. CTN 0064 will leverage the CTN 0049 research infrastructure and cohort by utilizing the 11 participating CTN 0049 research teams to recruit their randomized participants into the CTN 0064 study.

CTN 0064 has two main components: Component 1 is the baseline assessment for CTN 0064. It will also serve as a long-term follow-up assessment for CTN 0049 for those who consent to participate in CTN 0064. Participants whose HCV antibody test result is positive in this baseline assessment will be invited to enroll in Component 2. Component 2 is an RCT that will assess the effectiveness of a Care Facilitation intervention (compared to Control) in moving HIV/HCV co-infected substance users forward along the HCV care continuum. The study's primary objective is based on Component 2 and will be operationalized as movement through a series of (potentially non-sequential) pre-defined, clinical steps along the HCV care continuum (including the ultimate step, sustained virologic response to treatment at 12 weeks post treatment completion \[SVR12\]) (AASLD/IDSA/IAS-USA). Secondary objectives will be to assess: 1) success at each step in the HCV care continuum, 2) engagement in HIV care and substance use treatment, and 3) HIV viral suppression as well as 4) to examine other long-term outcomes of the CTN 0049 cohort.

All adults who were randomized into the CTN 0049 study and who provided consent to be contacted about future studies (hereafter, referred to as the "CTN 0049 cohort") will be invited to enroll in the CTN 0064 study. All participants will provide informed consent and complete Component 1, consisting of: 1) a computer assisted personal interview or CAPI (capturing history of HIV care, HCV testing and care, substance use and substance use treatment; mental health; demographics; and socio-economic factors), 2) HCV antibody screening via rapid HCV test (and, if HCV antibody positive, HCV RNA testing via venipuncture), 3) associated pre-/post-HCV test information and counseling, 4) blood specimen collection via venipuncture, and 5) drug/alcohol toxicology screening (via urine evaluation). The blood specimens of all participants will be assessed for HIV viral load and CD4 count. The blood specimens for the subset of participants who screen as HCV antibody positive will be assessed for HCV RNA to determine if their HCV infection is active.

Participants who screen as HCV antibody positive will be randomized into Component 2 and assigned to one of two groups: 1) HCV Care Facilitation intervention or 2) Control. The Care Facilitation intervention group will receive up to 12 sessions during a 6-month intervention period. Follow-up visits with both groups will be conducted at approximately 6 and 12 months post-randomization. These visits will consist of CAPI, blood specimen collection, and drug/alcohol toxicology screening. Medical records will be reviewed to document HCV testing, receipt and use of HCV clinical evaluation, care and treatment (as applicable); and HIV care and treatment before and during the study period.

Eligibility criteria: Inclusion Criteria:

By virtue of participating individuals being recruited from the CTN-0049 cohort, they will be:

1. HIV-infected and
2. 18 years of age or older
3. Be able to communicate in English

   Additionally, to be eligible for Component 1 they must:
4. provide informed consent, which includes being willing to provide sufficient locator information and to be tested for anti-HCV antibodies and, if antibody positive, tested for active HCV infection
5. sign a HIPAA form / medical record release form to facilitate medical record abstraction

   Finally, to continue on to Component 2, they must:
6. provide sufficient locator information
7. report living in the vicinity and being able to return for follow-up visits
8. complete the baseline assessments
9. complete the blood draw
10. test as HCV antibody positive via study Component 1 and,
11. agree to be randomized in Component 2

Exclusion Criteria:

Individuals will be excluded from participation if they:

1. have significant cognitive or developmental impairment
2. are terminated via Site Principal Investigator decision/discretion with agreement from study Lead Investigator
3. are currently in jail, prison or any inpatient overnight facility as required by court of law or have a pending legal action which may prevent an individual from completing the study

   Additionally, individuals may participate in Component 1, but will be excluded from Component 2 if they:
4. are currently on HCV therapy/medications at baseline
5. have completed a course of HCV medications in the last 12 weeks based on self-report.

It should be noted that pregnancy is not an exclusion criterion. Therefore, sites may enroll pregnant women and/or follow-up with already enrolled women who become pregnant after enrollment in the study provided that they have local IRB approval to do so.

Primary outcomes:
measure: Forward movement along the HCV care continuum assessed as the difference between the number of steps completed pre- and post-randomization (among Component 2 participants)
timeFrame: 14 months post-randomization (this is the outside window for the 12-month follow-up visit)
Secondary outcomes:
measure: HIV viral suppression
timeFrame: Assessed at the CTN 0064 baseline visit
measure: HIV care visit attendance
timeFrame: Assessed in the 6-month time period before the CTN 0064 baseline visit
measure: All-cause mortality
timeFrame: Time period will vary by participant between 9 months and 4 years depending when they were randomized into CTN 0049 and when they complete the CTN 0064 baseline assessment.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital at University of Alabama at Birmingham
state: Alabama
city: Torrance
country: United States
facility: Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Miami
country: United States
facility: Jackson Health System Adult HIV Outpatient Clinics / University of Miami
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital / Ponce de Leon Center
state: Georgia
city: Chicago
country: United States
facility: John H. Stroger Jr. Hospital of Cook County
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital / Moore Clinic
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai - St. Luke's Roosevelt Hospital Center
state: New York
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian / Pittsburgh AIDS Center for Treatment
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: Columbia University
name: Lisa R. Metsch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Carlos del Rio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Daniel J. Feaster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Carmen Masson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Icahn School of Medicine
name: David Perlman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Lauren K. Gooden, PhD
role: STUDY_DIRECTOR
References:
citation: Gutkind S, Starbird LE, Murphy SM, Teixeira PA, Gooden LK, Matheson T, Feaster DJ, Jain MK, Masson CL, Perlman DC, Del Rio C, Metsch LR, Schackman BR. Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs. Drug Alcohol Depend. 2022 Mar 1;232:109265. doi: 10.1016/j.drugalcdep.2022.109265. Epub 2022 Jan 10.
citation: Metsch LR, Feaster DJ, Gooden LK, Masson C, Perlman DC, Jain MK, Matheson T, Nelson CM, Jacobs P, Tross S, Haynes L, Lucas GM, Colasanti JA, Rodriguez A, Drainoni ML, Osorio G, Nijhawan AE, Jacobson JM, Sullivan M, Metzger D, Vergara-Rodriguez P, Lubelchek R, Duan R, Batycki JN, Matthews AG, Munoz F, Jelstrom E, Mandler R, Del Rio C. Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064). Open Forum Infect Dis. 2021 Jun 27;8(8):ofab334. doi: 10.1093/ofid/ofab334. eCollection 2021 Aug.