Trial Outcomes & Findings for Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults (NCT NCT04513899)
NCT ID: NCT04513899
Last Updated: 2024-03-01
Results Overview
The number of participants completing HCV treatment (7 days per week x 2- or 3 month treatment of DAA) was measured by pill count to measure adherence in both groups. For the RN/CHW group, directly observed therapy was utilized where the CHW or RN delivered the medication daily and documented each time s/he observed the participant swallow a pill. For the cbSOC Program (control group), the clinic-based MD/NP conducted a pill count monthly, based on the medications left in the pill bottle each month the participant is scheduled to pick up the next supply
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
2-3 months depending on which DAA drug was provided. Some required 2 months and others, 3 months.
Results posted on
2024-03-01
Participant Flow
Based on our protocol, after screening was conducted, all eligible participants (n = 10) were enrolled over the length of the study, and after informed consent was completed.
Participant milestones
| Measure |
Experimental: Community Health Worker/Registered Nurse (CHW/RN)
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
A team of 2-3 CHWs and a research RN delivered all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assessed HCV side effects, all under the guidance of their RN. Recruitment was continuous. After the first dose of the DAA, the CHW ran a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team stored the medication in a secure, locked cabinet at the research office. The CHW rigorously tracked participants who missed a dose, and were involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Active Comparator: Clinic-based Standard of Care (cbSOC)
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
This program was delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) were hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP conducted, per usual care at the study clinics, the education and monitoring of these participants who interacted with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care included: 1) HCV pre-treatment education; 2) two-three month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs were provided over the standard of care. The cbSOC participants did not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program received the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
Baseline characteristics by cohort
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=4 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=6 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
Total
n=10 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 6.75 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 9.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-3 months depending on which DAA drug was provided. Some required 2 months and others, 3 months.Population: All randomized participants
The number of participants completing HCV treatment (7 days per week x 2- or 3 month treatment of DAA) was measured by pill count to measure adherence in both groups. For the RN/CHW group, directly observed therapy was utilized where the CHW or RN delivered the medication daily and documented each time s/he observed the participant swallow a pill. For the cbSOC Program (control group), the clinic-based MD/NP conducted a pill count monthly, based on the medications left in the pill bottle each month the participant is scheduled to pick up the next supply
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=4 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=6 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
Number of Participants Completing HCV Treatment
|
3 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 5 or 6 monthsPopulation: All randomized participants
The number of participants who attained SVR12 Cure (HCV RNA \< 25 IU/ml, detectable or undetectable) as tested at 5 or 6-month follow-up (12 weeks after treatment completion)
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=4 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=6 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
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|---|---|---|
|
Number of Participants Attaining SVR12 (Sustained Viral Response at 12 Weeks After Treatment Completion)
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 or 3- and 5 or 6-month follow-upPopulation: Complete case
Assessed by drug items in the Texas Christian University (TCU) Screen V. Yes/No responses to substance dependency questions and the frequency of drug use based on a 5-point scale from 1 (never) to 5 (daily) was assessed for each drug used. The range of scores on the 11-item Yes/no questions analyzed ranged from ranges from 0 - 11; corresponding to the number of symptoms endorsed by the participant and the severity of SUD: Mild disorder (2-3 points), moderate disorder (4-5 points), or severe disorder (6 or more points). The total score was calculated by adding the scores for all questions and averaging for all the participants at each follow-up time point. Drug Use was assessed at "2 or 3" months and "5 or 6" months follow-up.
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=3 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=6 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
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|---|---|---|
|
Drug Use
2 or 3 month follow up
|
5 score on a scale
Standard Deviation 4
|
3.33 score on a scale
Standard Deviation 3.88
|
|
Drug Use
5 or 6 month follow up
|
2.7 score on a scale
Standard Deviation 3.8
|
4.8 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Assessment at 2 or 3- and 5 or 6-month follow-upPopulation: Complete case
Assessed by a brief alcohol screening instrument The Alcohol Use Disorders Identification Test-Concise (AUDIT-C). AUDIT-C reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. The higher the score the more severe is the alcohol disorder. The total score was calculated by adding the scores for all questions and averaging for all the participants at each follow-up time point Based on the duration of DAA prescribed for the HCV treatment, the follow-up period was at "2 or 3" months and "5 or 6" months.
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=3 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=5 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
2 or 3 month follow up
|
1.5 score on a scale
Standard Deviation 2.12
|
2.8 score on a scale
Standard Deviation 3.03
|
|
Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
5 or 6 month follow up
|
0.33 score on a scale
Standard Deviation 0.58
|
3.6 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 2 or 3- and 5 or 6-month follow-upPopulation: Complete case
Assessed by CAGE an internationally used assessment instrument for identifying alcoholics. Item responses on the CAGE are scored 0 or 1. The total score was calculated by adding up the scores for all four questions and averaging for all the participants for each time point. A total score of 2 or greater is considered clinically significant and may indicate alcohol-related issues. Based on the duration of DAA prescribed for the HCV treatment, the follow-up period was at "2 or 3" months and "5 or 6" months.
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=3 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=5 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
CAGE Substance Abuse Screening Scale
2 or 3 month follow up
|
0.667 score on a scale
Standard Deviation 1.15
|
0.4 score on a scale
Standard Deviation 0.894
|
|
CAGE Substance Abuse Screening Scale
5 or 6 month follow up
|
0 score on a scale
Standard Deviation 0
|
0.8 score on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: 2 or 3- and 5 or 6-month follow-upPopulation: Complete case
Mental Health will be assessed by Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a self-administered depression module of the Patient Health Questionnaire (PHQ). It contains 9 questions that help identify patients with clinically meaningful symptoms of depression. Patient responses are scored 0-3 with 0 representing "not at all" and 3 indicating "nearly every day;" thus, the PHQ-9 contains a total score range of 0-27. The total score was calculated by adding the scores for all questions and averaging for all the participants at each follow-up time point. The higher the score, the more severe is the alcohol disorder. Based on the duration of DAA prescribed for the HCV treatment, the follow-up period was at "2 or 3" months and "5 or 6" months.
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=3 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=5 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
Depression
2 or 3 month follow up
|
8 score on a scale
Standard Deviation 7.55
|
8 score on a scale
Standard Deviation 3.39
|
|
Depression
5 or 6 month follow up
|
2 score on a scale
Standard Deviation 0
|
7.6 score on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 2 or 3- and 5 or 6-month follow-upPopulation: Complete case
Mental Health was assessed by the Mental Health Inventory (MHI)-5; well-demonstrated reliability for detecting psychological disorders. The MHI-5 comprises five questions. There are six possible responses to the questions, scored between 1 and 6. The score for each individual therefore ranges between 5 and 30. This is then transformed into a variable ranging from 0-100 using a standard linear transformation. The higher the score, the better the perception of mental health. Based on the duration of DAA prescribed for the HCV treatment, the follow-up period was at "2 or 3" months and "5 or 6" months.
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=3 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=5 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
Mental Health
2 or 3 month follow up
|
65.3 units on a scale
Standard Deviation 32.3
|
76 units on a scale
Standard Deviation 18.8
|
|
Mental Health
5 or 6 month follow up
|
45.3 units on a scale
Standard Deviation 16.2
|
62.4 units on a scale
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: 2 or 3- and 5 or 6-month follow-upPopulation: Complete case
Health Care Access will include number of participants who completed 2 or more visits for health care or social services during the 2-3 month and 5-6 month follow-up
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=3 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=5 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
Health Care Access
5-6 month follow-up
|
3 Participants
|
1 Participants
|
|
Health Care Access
2-3 month follow-up
|
3 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: 2 or 3 months and 5 or 6 monthsPopulation: Complete Case
Shelter Stability is defined by number of participants who reported living in a shelter or apartment at month 2 or 3 and 5 or 6 months follow-up. The number of participants at each time period and in each arm were totaled.
Outcome measures
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=3 Participants
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=5 Participants
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
Shelter Stability
2 or 3 months
|
0 Participants
|
2 Participants
|
|
Shelter Stability
5 or 6 months
|
2 Participants
|
1 Participants
|
Adverse Events
Community Health Worker/Registered Nurse (CHW/RN)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Clinic-based Standard of Care (cbSOC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Community Health Worker/Registered Nurse (CHW/RN)
n=4 participants at risk
Nurse-led Community Health Worker (CHW/RN) program delivered DOT for HCV treatment.
Community health worker (CHW)/ registered nurse (RN) \[CHW/RN\]: A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
|
Clinic-based Standard of Care (cbSOC)
n=6 participants at risk
Standard of care for HCV treatment delivered by a clinic-based MD or clinic-based NP at the clinic site. "Other \[Not Including Serious\] Adverse Events were not monitored/assessed for cbSOC Arm"
Clinic-based Standard of Care (cbSOC) Program (control group): This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
|
|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 13 • 6 months
Same definition as clinicaltrials.gov
|
—
0/0 • 6 months
Same definition as clinicaltrials.gov
|
|
General disorders
Tiredness
|
75.0%
3/4 • Number of events 11 • 6 months
Same definition as clinicaltrials.gov
|
—
0/0 • 6 months
Same definition as clinicaltrials.gov
|
|
General disorders
Loss of appetite
|
50.0%
2/4 • Number of events 8 • 6 months
Same definition as clinicaltrials.gov
|
—
0/0 • 6 months
Same definition as clinicaltrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • 6 months
Same definition as clinicaltrials.gov
|
—
0/0 • 6 months
Same definition as clinicaltrials.gov
|
|
General disorders
Sleepiness
|
25.0%
1/4 • Number of events 1 • 6 months
Same definition as clinicaltrials.gov
|
—
0/0 • 6 months
Same definition as clinicaltrials.gov
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • 6 months
Same definition as clinicaltrials.gov
|
—
0/0 • 6 months
Same definition as clinicaltrials.gov
|
|
General disorders
Lightheadedness
|
50.0%
2/4 • Number of events 3 • 6 months
Same definition as clinicaltrials.gov
|
—
0/0 • 6 months
Same definition as clinicaltrials.gov
|
|
General disorders
Bleeding or bruising more easily than normal
|
25.0%
1/4 • Number of events 1 • 6 months
Same definition as clinicaltrials.gov
|
—
0/0 • 6 months
Same definition as clinicaltrials.gov
|
Additional Information
Dr Adeline Nyamathi
University of California, Irvine, Sue & Bill Gross School of Nursing
Phone: (949) 824-8932
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place