Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus
Conditions
Brief summary
This study is being done to compare three strategies to deliver HCV treatment with ledipasvir/sofosbuvir which is an approved therapy which is administered as one tablet by mouth daily for 12 weeks. The study population is persons living with HIV and hepatitis C virus (HCV) coinfection who also use drugs. Participants will be randomized into one of three treatment groups: 1. Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team. 2. Usual care plus peer-mentors. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection. 3. Usual care plus incentives. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain treatment goals during the course of the study. HCV treatment with ledipasvir/sofosbuvir is considered the standard of care for HCV and is recommended by experts in liver disease and infectious diseases.
Detailed description
Recent advances in Hepatitis C Virus (HCV) treatment represent a paradigm shift for the treatment of HCV-infected persons with Human Immunodeficiency Virus (HIV) coinfection. With potent antiviral activity, excellent safety/tolerability, few drug interactions and once daily, oral dosing, Sofosbuvir (SOF)/Ledipasvir (LDV) have had excellent efficacy in randomized controlled trials and offer great promise for the treatment of hepatitis C in HIV/HCV coinfected patients who are at high risk for progressive liver disease and HCV-related mortality. While the availability of SOF/LDV has great promise for the treatment of patients, the experience with antiretroviral therapy (ART) for the treatment of HIV infection indicates that interferon-free oral therapy is necessary but not sufficient to cure HCV in the real world. While removal of Interferon increases the proportion of coinfected persons who use drugs (PWUD) eligible for treatment, multiple barriers will remain (e.g., medical/psychiatric illness, substance abuse, and social constraints). Effective ART in coinfected PWUDs provides a strategic framework for the delivery of curative HCV treatment; novel and effective strategies for delivering this care for HCV must be evaluated, including incentives and peer-mentoring. Financial incentives. One method for increasing delivery of care is the contingent administration of monetary incentives; such reinforcements have improved health outcomes related to drug/alcohol abstinence, smoking cessation, childhood vaccination, tuberculosis care and HIV treatment. Contingent reinforcement has also been successfully used to link HIV-infected patients to care and improve adherence to ART. Curative HCV treatments are given for a finite duration (12 weeks) which offers an ideal paradigm for incentive interventions by reducing the overall cost and removing concerns of loss of adherence if incentives are stopped. Peer support. A second method for improving delivery of care is the use of peers or laypersons with the same illness. By matching on cultural competencies and establishing trust, peers may be particularly effective in some settings. In one study, African American veterans with poorly controlled diabetes assigned to peer-support had better glucose control than those assigned financial incentives. Coinfected patients may benefit from peer support. The investigators will test two innovative strategies to improve HCV treatment outcomes in HIV/HCV coinfected patients through the delivery of SOF/LDV for 12 weeks as part of a randomized controlled trial. HIV-infected patients will receive SOF/LDV under one of three randomly assigned conditions: usual care (clinic-based nursing model), incentive care (IC) or peer-mentor care (PMC).
Interventions
OTHERUsual care plus peer-mentors
Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
OTHERUsual care plus incentives
Participants are given incentives after completing treatment goals.
OTHERUsual Care
Participants receive standard of care in the clinic from their health care team.
Sponsors
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or greater * Hepatitis C genotype 1 infection for at least 6 months * No evidence of Hepatocellular Carcinoma or End-Stage Liver Disease (e.g., history of ascites, bleeding varices, and/or encephalopathy) * Cluster of Differentiation 4 (CD4) cell count \> 100 cells/mm3 for more than 3 months * HIV RNA positive for more than 3 months * Ability to communicate effectively with key study personnel * Willing to give written informed consent and comply with the study requirements * Life expectancy \> 2 year
Exclusion criteria
* Currently receiving Hepatitis C treatment * Renal insufficiency - estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: \<30 mL/min/1.73 m2 * Antiretroviral therapy inclusive of STRIBILD or APTIVUS * Inability or unwillingness to avoid pregnancy for woman of child-bearing potential and/or to father children during treatment and for a period of 3 months following completion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Initiated HCV Therapy by Intervention Group | at week 1 | The percentage of participants who initiated HCV therapy \[Ledipasvir/Sofosbuvir (LDV/SOF)\] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response (SVR) Following Treatment by Intervention Group | at post-treatment week 12 | The number of participants who achieved SVR, defined as HCV RNA not detected at 12 weeks after completion of the HCV treatment regimen |
| Number of Participants With Adverse Events During HCV Treatment by Intervention Group | at post-treatment week 12 | Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group |
| Change in Alcohol Use by Blood Test During HCV Treatment | Pre-treatment and at treatment week 6 | Alcohol intake during HCV treatment measured using dried whole blood spots to measure the level of phosphatidylethanol (PEth) at pre-treatment and treatment week 6 |
| Change in Illicit Drug Use During HCV Treatment | Pre-treatment and at treatment week 6 | Illicit drug use during HCV treatment measured by urine toxicology testing pre-treatment and at treatment week 6 |
| Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group | at post-treatment week 12 | Number of persons who achieved sustained virologic response following treatment who subsequently have HCV RNA detected with a new strain of the virus. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between August 2015 and October 2016 at an outpatient clinic in Baltimore, MD, USA.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants receive standard of care for Hepatitis C in the clinic.
Usual Care: Participants receive standard of care in the clinic from their health care team. | 36 |
| Usual Care Plus Peer-mentors In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.
Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni. | 54 |
| Usual Care Plus Incentives In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.
Usual care plus incentives: Participants are given incentives after completing treatment goals. | 54 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Did not pickup study medication | 12 | 9 | 13 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 |
| Overall Study | Reinfection | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care Plus Peer-mentors | Usual Care Plus Incentives | Total | Usual Care |
|---|---|---|---|---|
| Age, Continuous | 55.1 years | 54.0 years | 54.9 years | 55.8 years |
| Alanine Aminotransferase | 33 U/L | 29 U/L | 33 U/L | 39 U/L |
| alcohol use disorders identification test (AUDIT) 0-3 | 34 Participants | 35 Participants | 88 Participants | 19 Participants |
| alcohol use disorders identification test (AUDIT) ≥12 | 4 Participants | 10 Participants | 14 Participants | 0 Participants |
| alcohol use disorders identification test (AUDIT) 4-7 | 10 Participants | 8 Participants | 31 Participants | 13 Participants |
| alcohol use disorders identification test (AUDIT) 8-11 | 6 Participants | 1 Participants | 11 Participants | 4 Participants |
| alcohol use disorders identification test (AUDIT) Female <4 | 13 Participants | 16 Participants | 36 Participants | 7 Participants |
| alcohol use disorders identification test (AUDIT) Female ≥4 | 6 Participants | 7 Participants | 20 Participants | 7 Participants |
| alcohol use disorders identification test (AUDIT) Male <8 | 28 Participants | 22 Participants | 70 Participants | 20 Participants |
| alcohol use disorders identification test (AUDIT) Male ≥8 | 7 Participants | 9 Participants | 18 Participants | 2 Participants |
| Aspartate Aminotransferase | 39 U/L | 36 U/L | 40 U/L | 45 U/L |
| Centers for Depression Epidemiology Scale (CES-D) <16 | 20 Participants | 20 Participants | 56 Participants | 16 Participants |
| Centers for Depression Epidemiology Scale (CES-D) ≥16 | 34 Participants | 34 Participants | 88 Participants | 20 Participants |
| Centers for Depression Epidemiology Scale (CES-D) <21 | 29 Participants | 31 Participants | 82 Participants | 22 Participants |
| Centers for Depression Epidemiology Scale (CES-D) ≥21 | 25 Participants | 23 Participants | 62 Participants | 14 Participants |
| Cluster of differentiation 4 (CD4) Count | 581 cells/mm^3 | 509 cells/mm^3 | 530 cells/mm^3 | 453 cells/mm^3 |
| Emotional Support <33 | 24 Participants | 21 Participants | 56 Participants | 11 Participants |
| Emotional Support ≥33 | 30 Participants | 33 Participants | 88 Participants | 25 Participants |
| Employment Status Employed | 7 Participants | 9 Participants | 22 Participants | 6 Participants |
| Employment Status Unemployed | 47 Participants | 45 Participants | 122 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 54 Participants | 144 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Has Health Insurance Does Not Have Health Insurance | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Has Health Insurance Has Health Insurance | 54 Participants | 54 Participants | 144 Participants | 36 Participants |
| HCV Genotype/Subtype 1A | 40 Participants | 43 Participants | 112 Participants | 29 Participants |
| HCV Genotype/Subtype 1B | 14 Participants | 11 Participants | 32 Participants | 7 Participants |
| HCV RNA | 4790000 IU/mL | 2730000 IU/mL | 2975000 IU/mL | 2730000 IU/mL |
| HIV antiretroviral therapy (ART) Changed Pre-Treatment with Harvoni No | 39 Participants | 41 Participants | 101 Participants | 21 Participants |
| HIV antiretroviral therapy (ART) Changed Pre-Treatment with Harvoni Yes | 11 Participants | 7 Participants | 28 Participants | 10 Participants |
| HIV RNA copies ≤50 | 43 Participants | 42 Participants | 115 Participants | 30 Participants |
| HIV RNA copies >50 | 11 Participants | 12 Participants | 29 Participants | 6 Participants |
| HIV RNA if ≥50 copies/mL | 645 copies/mL | 15903 copies/mL | 5702 copies/mL | 20767 copies/mL |
| Liver Disease Stage by FibroScan ≥12 kPa | 5 Participants | 7 Participants | 16 Participants | 4 Participants |
| Liver Disease Stage by FibroScan 8.1-11.9 kPa | 13 Participants | 7 Participants | 31 Participants | 11 Participants |
| Liver Disease Stage by FibroScan ≤8 kPa | 34 Participants | 36 Participants | 90 Participants | 20 Participants |
| Liver Disease Stage by FibroScan Unsuccessful | 2 Participants | 4 Participants | 7 Participants | 1 Participants |
| Liver Disease Stage by FibroScan | 6.8 kPa | 6.7 kPa | 6.9 kPa | 7.8 kPa |
| Marital Status Divorced | 8 Participants | 9 Participants | 23 Participants | 6 Participants |
| Marital Status Married | 13 Participants | 5 Participants | 23 Participants | 5 Participants |
| Marital Status Never Married | 27 Participants | 26 Participants | 72 Participants | 19 Participants |
| Marital Status Separated | 3 Participants | 5 Participants | 11 Participants | 3 Participants |
| Marital Status Widowed | 3 Participants | 9 Participants | 15 Participants | 3 Participants |
| Number of times rescheduled or missed week 0 clinical appointment for initial evaluation 0 | 39 Participants | 35 Participants | 100 Participants | 26 Participants |
| Number of times rescheduled or missed week 0 clinical appointment for initial evaluation 1-2 | 10 Participants | 16 Participants | 35 Participants | 9 Participants |
| Number of times rescheduled or missed week 0 clinical appointment for initial evaluation 3+ | 5 Participants | 3 Participants | 9 Participants | 1 Participants |
| Patient taking antiretroviral therapy No | 2 Participants | 2 Participants | 5 Participants | 1 Participants |
| Patient taking antiretroviral therapy Yes | 52 Participants | 52 Participants | 139 Participants | 35 Participants |
| phosphatidylethanol (ng/mL) <50 ng/mL | 33 Participants | 37 Participants | 88 Participants | 18 Participants |
| phosphatidylethanol (ng/mL) ≥50 ng/mL | 19 Participants | 13 Participants | 47 Participants | 15 Participants |
| Primary Care Visit in the last 12 months No | 4 Participants | 1 Participants | 5 Participants | 0 Participants |
| Primary Care Visit in the last 12 months Yes | 48 Participants | 52 Participants | 136 Participants | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants | 48 Participants | 133 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 6 Participants | 11 Participants | 3 Participants |
| Region of Enrollment United States | 54 participants | 54 participants | 144 participants | 36 participants |
| Self-report current alcohol use 2-3x per week | 4 Participants | 5 Participants | 14 Participants | 5 Participants |
| Self-report current alcohol use 2-4x per month | 12 Participants | 7 Participants | 24 Participants | 5 Participants |
| Self-report current alcohol use ≥4x per week | 3 Participants | 8 Participants | 14 Participants | 3 Participants |
| Self-report current alcohol use Monthly or Less | 12 Participants | 12 Participants | 33 Participants | 9 Participants |
| Self-report current alcohol use Never | 23 Participants | 22 Participants | 59 Participants | 14 Participants |
| Self-report Do you think your doctor understands the pressure you are under outside of the clinic? Don't Know | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Self-report Do you think your doctor understands the pressure you are under outside of the clinic? No | 42 Participants | 41 Participants | 112 Participants | 29 Participants |
| Self-report Do you think your doctor understands the pressure you are under outside of the clinic? Under No Pressure | 2 Participants | 2 Participants | 5 Participants | 1 Participants |
| Self-report Do you think your doctor understands the pressure you are under outside of the clinic? Yes | 7 Participants | 9 Participants | 22 Participants | 6 Participants |
| Self-report fatigue <16 | 24 Participants | 22 Participants | 64 Participants | 18 Participants |
| Self-report fatigue ≥16 | 30 Participants | 32 Participants | 80 Participants | 18 Participants |
| Sex: Female, Male Female | 19 Participants | 23 Participants | 56 Participants | 14 Participants |
| Sex: Female, Male Male | 35 Participants | 31 Participants | 88 Participants | 22 Participants |
| Substance Use History- Self Report Self-Report of Drug Use (any) in the Last 2 Years No | 21 Participants | 21 Participants | 54 Participants | 12 Participants |
| Substance Use History- Self Report Self-Report of Drug Use (any) in the Last 2 Years Yes | 33 Participants | 33 Participants | 90 Participants | 24 Participants |
| Substance Use History- Self Report Self-report use of cocaine or heroin- last 30 days No | 42 Participants | 42 Participants | 108 Participants | 24 Participants |
| Substance Use History- Self Report Self-report use of cocaine or heroin- last 30 days Yes | 12 Participants | 12 Participants | 36 Participants | 12 Participants |
| Substance Use History- Self Report Self-report use of cocaine or heroin- lifetime No | 6 Participants | 6 Participants | 13 Participants | 1 Participants |
| Substance Use History- Self Report Self-report use of cocaine or heroin- lifetime Yes | 48 Participants | 48 Participants | 131 Participants | 35 Participants |
| Urine Toxicology Benzodiazepine | 5 Participants | 6 Participants | 14 Participants | 3 Participants |
| Urine Toxicology Cannabinoid | 19 Participants | 13 Participants | 41 Participants | 9 Participants |
| Urine Toxicology Cocaine | 12 Participants | 19 Participants | 43 Participants | 12 Participants |
| Urine Toxicology Heroin | 16 Participants | 14 Participants | 36 Participants | 6 Participants |
| Urine Toxicology Methadone | 15 Participants | 13 Participants | 38 Participants | 10 Participants |
| Urine Toxicology Negative or only methadone | 16 Participants | 19 Participants | 45 Participants | 10 Participants |
| Urine Toxicology Negative or only methadone or oxycodone | 17 Participants | 20 Participants | 48 Participants | 11 Participants |
| Urine Toxicology Negative or only methadone or oxycodone or benzodi | 18 Participants | 23 Participants | 52 Participants | 11 Participants |
| Urine Toxicology Negative or only methadone or oxycodone or marijua | 27 Participants | 24 Participants | 68 Participants | 17 Participants |
| Urine Toxicology None of the Above Detected | 13 Participants | 16 Participants | 36 Participants | 7 Participants |
| Urine Toxicology Not Done | 3 Participants | 0 Participants | 8 Participants | 5 Participants |
| Urine Toxicology Oxycod/ Oxymorph | 1 Participants | 4 Participants | 9 Participants | 4 Participants |
| Urine Toxicology Positive for cocaine and heroin only | 2 Participants | 1 Participants | 4 Participants | 1 Participants |
| Urine Toxicology Positive for cocaine only | 3 Participants | 4 Participants | 8 Participants | 1 Participants |
| Urine Toxicology Positive for cocaine OR heroin | 23 Participants | 27 Participants | 63 Participants | 13 Participants |
| Urine Toxicology Positive for Heroin only | 2 Participants | 4 Participants | 7 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 24 | 0 / 45 | 0 / 41 |
| other Total, other adverse events | 11 / 24 | 18 / 45 | 19 / 41 |
| serious Total, serious adverse events | 3 / 24 | 9 / 45 | 9 / 41 |
Outcome results
Primary
Participants Who Initiated HCV Therapy by Intervention Group
The percentage of participants who initiated HCV therapy \[Ledipasvir/Sofosbuvir (LDV/SOF)\] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC).
Time frame: at week 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Participants Who Initiated HCV Therapy by Intervention Group | 24 Participants |
| Usual Care Plus Peer-mentors | Participants Who Initiated HCV Therapy by Intervention Group | 45 Participants |
| Usual Care Plus Incentives | Participants Who Initiated HCV Therapy by Intervention Group | 41 Participants |
Comparison: Sample size was based on an estimated HCV treatment initiation rate of 50% in the UC group (based on a 33% rate observed during the interferon era) and 80% in the intervention groups, a significance level of 0.05, a desired ratio of participants in the intervention group compared to UC group of 3 to 2, and power of 80% to detect this difference between groups. The study was not powered to detect differences between the peer and cash groups.p-value: 0.11Chi-squared
Secondary
Change in Alcohol Use by Blood Test During HCV Treatment
Alcohol intake during HCV treatment measured using dried whole blood spots to measure the level of phosphatidylethanol (PEth) at pre-treatment and treatment week 6
Time frame: Pre-treatment and at treatment week 6
Population: Participants that completed PEth tests at enrollment and week 6 of treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Change in Alcohol Use by Blood Test During HCV Treatment | Increase in alcohol use from week 0 to week 6 | 0 Participants |
| Usual Care | Change in Alcohol Use by Blood Test During HCV Treatment | No change in alcohol use from week 0 to week 6 | 20 Participants |
| Usual Care | Change in Alcohol Use by Blood Test During HCV Treatment | Decrease in alcohol use from week 0 to week 6 | 2 Participants |
| Usual Care Plus Peer-mentors | Change in Alcohol Use by Blood Test During HCV Treatment | Increase in alcohol use from week 0 to week 6 | 0 Participants |
| Usual Care Plus Peer-mentors | Change in Alcohol Use by Blood Test During HCV Treatment | No change in alcohol use from week 0 to week 6 | 38 Participants |
| Usual Care Plus Peer-mentors | Change in Alcohol Use by Blood Test During HCV Treatment | Decrease in alcohol use from week 0 to week 6 | 3 Participants |
| Usual Care Plus Incentives | Change in Alcohol Use by Blood Test During HCV Treatment | No change in alcohol use from week 0 to week 6 | 32 Participants |
| Usual Care Plus Incentives | Change in Alcohol Use by Blood Test During HCV Treatment | Decrease in alcohol use from week 0 to week 6 | 1 Participants |
| Usual Care Plus Incentives | Change in Alcohol Use by Blood Test During HCV Treatment | Increase in alcohol use from week 0 to week 6 | 2 Participants |
Comparison: changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.p-value: 0.33Chi-squared
Secondary
Change in Illicit Drug Use During HCV Treatment
Illicit drug use during HCV treatment measured by urine toxicology testing pre-treatment and at treatment week 6
Time frame: Pre-treatment and at treatment week 6
Population: Participants that completed urine toxicology tests at enrollment and week 6 of treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Change in Illicit Drug Use During HCV Treatment | Increase in cocaine or heroin use from wk 0 to 6 | 5 Participants |
| Usual Care | Change in Illicit Drug Use During HCV Treatment | No change in cocaine or heroin use from wk 0 to 6 | 16 Participants |
| Usual Care | Change in Illicit Drug Use During HCV Treatment | Decrease in cocaine or heroin use from wk 0 to 6 | 3 Participants |
| Usual Care Plus Peer-mentors | Change in Illicit Drug Use During HCV Treatment | Increase in cocaine or heroin use from wk 0 to 6 | 4 Participants |
| Usual Care Plus Peer-mentors | Change in Illicit Drug Use During HCV Treatment | No change in cocaine or heroin use from wk 0 to 6 | 37 Participants |
| Usual Care Plus Peer-mentors | Change in Illicit Drug Use During HCV Treatment | Decrease in cocaine or heroin use from wk 0 to 6 | 4 Participants |
| Usual Care Plus Incentives | Change in Illicit Drug Use During HCV Treatment | No change in cocaine or heroin use from wk 0 to 6 | 34 Participants |
| Usual Care Plus Incentives | Change in Illicit Drug Use During HCV Treatment | Decrease in cocaine or heroin use from wk 0 to 6 | 5 Participants |
| Usual Care Plus Incentives | Change in Illicit Drug Use During HCV Treatment | Increase in cocaine or heroin use from wk 0 to 6 | 2 Participants |
p-value: 0.3Chi-squared
Secondary
Number of Participants With Adverse Events During HCV Treatment by Intervention Group
Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group
Time frame: at post-treatment week 12
Population: Among participants that initiated treatment only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Adverse Events During HCV Treatment by Intervention Group | 13 Participants |
| Usual Care Plus Peer-mentors | Number of Participants With Adverse Events During HCV Treatment by Intervention Group | 24 Participants |
| Usual Care Plus Incentives | Number of Participants With Adverse Events During HCV Treatment by Intervention Group | 20 Participants |
Secondary
Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group
Number of persons who achieved sustained virologic response following treatment who subsequently have HCV RNA detected with a new strain of the virus.
Time frame: at post-treatment week 12
Population: Among participants that initiated treatment only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group | 0 Participants |
| Usual Care Plus Peer-mentors | Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group | 0 Participants |
| Usual Care Plus Incentives | Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group | 1 Participants |
Secondary
Sustained Virologic Response (SVR) Following Treatment by Intervention Group
The number of participants who achieved SVR, defined as HCV RNA not detected at 12 weeks after completion of the HCV treatment regimen
Time frame: at post-treatment week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Sustained Virologic Response (SVR) Following Treatment by Intervention Group | 22 Participants |
| Usual Care Plus Peer-mentors | Sustained Virologic Response (SVR) Following Treatment by Intervention Group | 41 Participants |
| Usual Care Plus Incentives | Sustained Virologic Response (SVR) Following Treatment by Intervention Group | 37 Participants |
p-value: 0.22Chi-squared