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.

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.

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.