Trial Outcomes & Findings for Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection (NCT NCT02707991)
NCT ID: NCT02707991
Last Updated: 2019-05-02
Results Overview
This will be assessed based on the number of participants who attend an appointment at the Viral Hepatitis Clinic within 60 days of enrolling in the study. A participant is considered "linked to care" if he/she attends an appointment at the clinic. A participant is considered "not linked to care" if he/she does not attend an appointment at the clinic. Whether a participant linked to care will be determined by looking at the medical record, where all attended appointments are documented. If no attended appointment is documented, this will be considered non-attendance/not linked to care.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
60 days
Results posted on
2019-05-02
Participant Flow
Recruitment took place from July 2016 to February 2018 in an outpatient infectious disease clinic in Baltimore, Maryland
Participant milestones
| Measure |
Enhanced Usual Care
Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
|
Nurse Case Management
Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention
Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
35
|
|
Overall Study
Day 60 Data Collectio
|
32
|
34
|
|
Overall Study
Month 6 Data Collection
|
32
|
34
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Enhanced Usual Care
Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
|
Nurse Case Management
Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention
Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Became ineligible
|
0
|
1
|
Baseline Characteristics
Nurse Case Management to Improve Hepatitis C Care in HIV Co-infection
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=33 Participants
Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
|
Nurse Case Management
n=35 Participants
Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention
Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
55.32 years
STANDARD_DEVIATION 7.73 • n=5 Participants
|
54.76 years
STANDARD_DEVIATION 7.68 • n=7 Participants
|
55.03 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
HIV viral load
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Liver fibrosis level
Less than F2
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Liver fibrosis level
Greater than or equal to F2
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Liver fibrosis level
Unknown
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Health insurance
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Hepatitis C knowledge
|
15.39 units on a scale
STANDARD_DEVIATION 2.01 • n=5 Participants
|
14.83 units on a scale
STANDARD_DEVIATION 2.12 • n=7 Participants
|
15.10 units on a scale
STANDARD_DEVIATION 2.07 • n=5 Participants
|
|
Alcohol use
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Injection drug use
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: All eligible participants who were randomized are included. Two participants were excluded (one in each arm) because they were found to be ineligible for study participation after they were randomized.
This will be assessed based on the number of participants who attend an appointment at the Viral Hepatitis Clinic within 60 days of enrolling in the study. A participant is considered "linked to care" if he/she attends an appointment at the clinic. A participant is considered "not linked to care" if he/she does not attend an appointment at the clinic. Whether a participant linked to care will be determined by looking at the medical record, where all attended appointments are documented. If no attended appointment is documented, this will be considered non-attendance/not linked to care.
Outcome measures
| Measure |
Enhanced Usual Care
n=32 Participants
Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
|
Nurse Case Management
n=34 Participants
Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention
Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
|
|---|---|---|
|
Number of Participants Linked to Care
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ll eligible participants who were randomized are included. Two participants were excluded (one in each arm) because they were found to be ineligible for study participation after they were randomized.
Number of days from study enrollment to receipt of the first dose of hepatitis C treatment
Outcome measures
| Measure |
Enhanced Usual Care
n=32 Participants
Usual clinic appointment process plus receipt of the Centers for Disease Control and Prevention (CDC) Hepatitis C Fact Sheet
|
Nurse Case Management
n=34 Participants
Nurse-initiated hepatitis C clinic referral, strengths-based education, patient navigation, appointment reminders, and care coordination of HIV/hepatitis C drug-drug interaction prevention
Nurse Case Management: Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
|
|---|---|---|
|
Time to Hepatitis C Treatment Initiation
|
103 days
Standard Deviation 48.5
|
79.3 days
Standard Deviation 26.8
|
Adverse Events
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nurse Case Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place