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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA016065-12 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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:
HCV treatment with ledipasvir/sofosbuvir is considered the standard of care for HCV and is recommended by experts in liver disease and infectious diseases.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Participants receive standard of care for Hepatitis C in the clinic. |
|
| Usual care plus peer-mentors | Experimental | 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 incentives | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care plus peer-mentors | Other | Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at post-treatment week 12 |
| Number of Participants With Adverse Events During HCV Treatment by Intervention Group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sulkowski, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital : The John G. Bartlett Specialty Practice | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31049365 | Derived | Ward KM, Falade-Nwulia O, Moon J, Sutcliffe CG, Brinkley S, Haselhuhn T, Katz S, Herne K, Arteaga L, Mehta SH, Latkin C, Brooner RK, Sulkowski MS. A Randomized Controlled Trial of Cash Incentives or Peer Support to Increase HCV Treatment for Persons With HIV Who Use Drugs: The CHAMPS Study. Open Forum Infect Dis. 2019 Apr 9;6(4):ofz166. doi: 10.1093/ofid/ofz166. eCollection 2019 Apr. |
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Participants were enrolled between August 2015 and October 2016 at an outpatient clinic in Baltimore, MD, USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care Plus Peer-mentors | In addition to receiving standard of care for hepatitis C virus (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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care Plus Peer-mentors |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | at week 1 |
|
From treatment initiation to post-treatment week 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care With LDV/SOF | 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. This group of patients initiated treatment with LDV/SOF. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emphysema/COPD/SOB | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Sulkowski | Johns Hopkins School of Medicine | 443-997-1900 | msulkowski@jhmi.edu |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| Usual care plus incentives | Other | Participants are given incentives after completing treatment goals. |
|
| Usual Care | Other | Participants receive standard of care in the clinic from their health care team. |
|
Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group |
| at post-treatment week 12 |
| 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 | Pre-treatment and at treatment week 6 |
| 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 | Pre-treatment and at treatment week 6 |
| 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. | at post-treatment week 12 |
| Death |
|
| Reinfection |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Has Health Insurance | Count of Participants | Participants |
|
| Substance Use History- Self Report | Count of Participants | Participants |
|
| Urine Toxicology | 5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline. | Count of Participants | Participants |
|
| phosphatidylethanol (ng/mL) | 3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline. | Count of Participants | Participants |
|
| Self-report current alcohol use | Count of Participants | Participants |
|
| alcohol use disorders identification test (AUDIT) | The Alcohol Use Disorders Identification Test (AUDIT) was developed by the World Health Organization and includes 10 questions that assess alcohol use and drinking behaviors. For this study, AUDIT scores ≥8 for men and ≥4 for women were categorized as hazardous drinking. Scores range from 0 to 40, with higher scores indicating greater alcohol dependence. | Count of Participants | Participants |
|
| alcohol use disorders identification test (AUDIT) | The Alcohol Use Disorders Identification Test (AUDIT) was developed by the World Health Organization and includes 10 questions that assess alcohol use and drinking behaviors. For this study, AUDIT scores ≥4 were categorized as hazardous drinking. Scores range from 0 to 40, with higher scores indicating greater alcohol dependence. | Count of Participants | Participants |
|
| HIV RNA copies | Count of Participants | Participants |
|
| HIV RNA if ≥50 copies/mL | Median | Full Range | copies/mL |
|
| Alanine Aminotransferase | ALT not done for 1 participant in peer mentor group | Median | Full Range | U/L |
|
| Aspartate Aminotransferase | AST not done for 2 participants in peer group and 3 participants in incentive group | Median | Full Range | U/L |
|
| Patient taking antiretroviral therapy | Count of Participants | Participants |
|
| HIV antiretroviral therapy (ART) Changed Pre-Treatment with Harvoni | This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study. | Count of Participants | Participants |
|
| HCV Genotype/Subtype | Count of Participants | Participants |
|
| HCV RNA | Median | Full Range | IU/mL |
|
| Liver Disease Stage by FibroScan | 7 unsuccessful FibroScan measurements due to participant's body type | Median | Inter-Quartile Range | kPa |
|
| Liver Disease Stage by FibroScan | Count of Participants | Participants |
|
| Cluster of differentiation 4 (CD4) Count | Median | Inter-Quartile Range | cells/mm^3 |
|
| Centers for Depression Epidemiology Scale (CES-D) | In this study, active depression is defined as score ≥16. This is a measure that asks patients to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. | Count of Participants | Participants |
|
| Centers for Depression Epidemiology Scale (CES-D) | Measure Description: In this study, severe active depression is defined as score ≥21. This is a measure that asks patients to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Scores range from 0 to 60, with high scores indicating greater depressive symptoms. | Count of Participants | Participants |
|
| Number of times rescheduled or missed week 0 clinical appointment for initial evaluation | Count of Participants | Participants |
|
| Emotional Support | Patient-Reported Outcomes Measurement Information System Short Form v2.0, Emotional Support 8a; low support defined as short form score <33 | Count of Participants | Participants |
|
| Self-report fatigue | Patient-Reported Outcomes Measurement Information System v1.0, Fatigue Short Form 7a; Fatigue defined as ≥16 | Count of Participants | Participants |
|
| Primary Care Visit in the last 12 months | Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group. | Count of Participants | Participants |
|
| Self-report "Do you think your doctor understands the pressure you are under outside of the clinic?" | Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group. | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
|
| 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 | Posted | Count of Participants | Participants | at post-treatment week 12 |
|
|
|
|
| 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 | Among participants that initiated treatment only. | Posted | Count of Participants | Participants | at post-treatment week 12 |
|
|
|
| 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 | Participants that completed PEth tests at enrollment and week 6 of treatment | Posted | Count of Participants | Participants | Pre-treatment and at treatment week 6 |
|
|
|
|
| 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 | Participants that completed urine toxicology tests at enrollment and week 6 of treatment | Posted | Count of Participants | Participants | Pre-treatment and at treatment week 6 |
|
|
|
|
| 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. | Among participants that initiated treatment only. | Posted | Count of Participants | Participants | at post-treatment week 12 |
|
|
|
| 1 |
| 24 |
| 3 |
| 24 |
| 11 |
| 24 |
| EG001 | Usual Care Plus Peer-mentors With LDV/SOF | 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 LDV/SOF. This group of patients initiated treatment with LDV/SOF. | 0 | 45 | 9 | 45 | 18 | 45 |
| EG002 | Usual Care Plus Incentives With LDV/SOF | 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. This group of patients initiated treatment with LDV/SOF. | 0 | 41 | 9 | 41 | 19 | 41 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back Pain | General disorders | Systematic Assessment |
|
| Leg Pain | General disorders | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Otitis media with effusion | Ear and labyrinth disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Scabies | Infections and infestations | Systematic Assessment |
|
| Poorly-controlled diabetes | Endocrine disorders | Systematic Assessment |
|
| Hyperkalemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Anion gap metabolic acidosis | General disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Acute Decompensated Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Kidney Stones | Renal and urinary disorders | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Elevated liver enzymes | Gastrointestinal disorders | Systematic Assessment |
|
| Motor Vehicle Accident | Social circumstances | Systematic Assessment |
|
| Pregnancy | Reproductive system and breast disorders | Systematic Assessment |
|
| Alcohol withdrawal | Psychiatric disorders | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| Abcess | Infections and infestations | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| acute congestive heart failure exacerbation | Cardiac disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Diabetic ketoacidosis | Endocrine disorders | Systematic Assessment |
|
| cellulitis of left arm during pregnancy | Infections and infestations | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| No |
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| ≥50 ng/mL |
|
| Monthly or Less |
|
| 2-4x per month |
|
| 2-3x per week |
|
| ≥4x per week |
|
| Male ≥8 |
|
| Female <4 |
|
| Female ≥4 |
|
| 4-7 |
|
| 8-11 |
|
| ≥12 |
|
| >50 |
|
| No |
|
| No |
|
| 1B |
|
| 8.1-11.9 kPa |
|
| ≥12 kPa |
|
| Unsuccessful |
|
| ≥16 |
|
| ≥21 |
|
| 1-2 |
|
| 3+ |
|
| ≥33 |
|
| ≥16 |
|
| No |
|
| No |
|
| Under No Pressure |
|
| Don't Know |
|
|
| Decrease in alcohol use from week 0 to week 6 |
|
|
| Decrease in cocaine or heroin use from wk 0 to 6 |
|