Trial Outcomes & Findings for Financial Incentives, Randomization With Stepped Treatment Trial (NCT NCT03089320)

Results Overview

Recorded via web based time-line followback

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

6 months

Results posted on

2024-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment As Usual (TAU) We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.	Contingency Management Plus Stepped Care (Step 2) Step 1: Contingency management (CM); Step 2: Addiction physician management and motivational enhancement therapy We provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth \> 8 ng/ml will continue on to Step 2. Contingency Management Counseling: CM is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. Addiction Physician Management: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. Motivational Enhancement Therapy: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite MotivationalEnhancement Therapy (MET) from the Social Worker (SW) in the HIV clinic. The SW's role is to assist the patient in moving through the stages of change using motivational interviewing and reflective listening to help patients identify internal motivation to reduce alcohol use.
Overall Study STARTED	60	60
Overall Study COMPLETED	57	51
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Financial Incentives, Randomization With Stepped Treatment Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment As Usual (TAU) n=60 Participants We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.	Contingency Management Plus Stepped Care (Step 2) n=60 Participants Step 1: Contingency management (CM); Step 2: Addiction physician management and motivational enhancement therapy We provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth \> 8 ng/ml will continue on to Step 2. Contingency Management Counseling: CM is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. Addiction Physician Management: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. Motivational Enhancement Therapy: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite MotivationalEnhancement Therapy (MET) from the Social Worker (SW) in the HIV clinic. The SW's role is to assist the patient in moving through the stages of change using motivational interviewing and reflective listening to help patients identify internal motivation to reduce alcohol use.	Total n=120 Participants Total of all reporting groups
Age, Continuous	59.00 years STANDARD_DEVIATION 8.29 • n=5 Participants	58.65 years STANDARD_DEVIATION 10.72 • n=7 Participants	58.82 years STANDARD_DEVIATION 9.54 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	56 Participants n=7 Participants	115 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 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	1 Participants n=7 Participants	1 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	53 Participants n=5 Participants	47 Participants n=7 Participants	100 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants randomized to CMSC orTAU.

Recorded via web based time-line followback

Outcome measures

Outcome measures
Measure	Contingency Management Plus Stepped Care (Step 2) n=60 Participants Step 1: Contingency management (CM); Step 2: Addiction physician management and motivational enhancement therapy We provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth \> 8 ng/ml will continue on to Step 2. Contingency Management Counseling: CM is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. Addiction Physician Management: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. Motivational Enhancement Therapy: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite MotivationalEnhancement Therapy (MET) from the Social Worker (SW) in the HIV clinic. The SW's role is to assist the patient in moving through the stages of change using motivational interviewing and reflective listening to help patients identify internal motivation to reduce alcohol use.	Treatment As Usual (TAU) n=60 Participants We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.
Self-reported Abstinence From Alcohol	9.44 percentage of participants Interval 0.1 to 32.89	0.32 percentage of participants Interval 0.0 to 3.91

SECONDARY outcome

Timeframe: 6 month

Population: All participants randomized to CMSC orTAU.

Phosphatidylethanol (PEth) accumulates in human red blood cells when the body is exposed to ethanol. Alcohol biomarkers are physiological indicators of alcohol exposure or ingestion and may reflect the presence of chronic and/or high level of use of alcohol. This will be evaluated as a binary variable to determine the proportion with abstinence (defined as % with PEth value \<8ng/mL).

Outcome measures

Outcome measures
Measure	Contingency Management Plus Stepped Care (Step 2) n=60 Participants Step 1: Contingency management (CM); Step 2: Addiction physician management and motivational enhancement therapy We provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth \> 8 ng/ml will continue on to Step 2. Contingency Management Counseling: CM is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. Addiction Physician Management: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. Motivational Enhancement Therapy: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite MotivationalEnhancement Therapy (MET) from the Social Worker (SW) in the HIV clinic. The SW's role is to assist the patient in moving through the stages of change using motivational interviewing and reflective listening to help patients identify internal motivation to reduce alcohol use.	Treatment As Usual (TAU) n=60 Participants We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.
Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth)	5.86 percentage of participants Interval 0.3 to 18.91	0.36 percentage of participants Interval 0.0 to 3.59

SECONDARY outcome

Timeframe: 6 months

Population: All participants randomized to CMSC or TAU

The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. Possible scores range from 0 to 164. A higher score indicates greater burden of disease.

Outcome measures

Outcome measures
Measure	Contingency Management Plus Stepped Care (Step 2) n=60 Participants Step 1: Contingency management (CM); Step 2: Addiction physician management and motivational enhancement therapy We provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth \> 8 ng/ml will continue on to Step 2. Contingency Management Counseling: CM is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. Addiction Physician Management: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. Motivational Enhancement Therapy: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite MotivationalEnhancement Therapy (MET) from the Social Worker (SW) in the HIV clinic. The SW's role is to assist the patient in moving through the stages of change using motivational interviewing and reflective listening to help patients identify internal motivation to reduce alcohol use.	Treatment As Usual (TAU) n=60 Participants We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.
Change in Biological Markers as Measured by the VACS Index	30.25 score on a scale Interval 23.6 to 36.9	35.57 score on a scale Interval 27.46 to 41.68

Adverse Events

Treatment As Usual (TAU)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Contingency Management Plus Stepped Care (Step 2)

Serious events: 7 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treatment As Usual (TAU) n=60 participants at risk We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.	Contingency Management Plus Stepped Care (Step 2) n=60 participants at risk Step 1: Contingency management (CM); Step 2: Addiction physician management and motivational enhancement therapy We provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth \> 8 ng/ml will continue on to Step 2. Contingency Management Counseling: CM is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. Addiction Physician Management: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. Motivational Enhancement Therapy: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite MotivationalEnhancement Therapy (MET) from the Social Worker (SW) in the HIV clinic. The SW's role is to assist the patient in moving through the stages of change using motivational interviewing and reflective listening to help patients identify internal motivation to reduce alcohol use.
General disorders Death	0.00% 0/60 • 1 year	3.3% 2/60 • 1 year
General disorders Other SAEs	1.7% 1/60 • 1 year	8.3% 5/60 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory SAE	1.7% 1/60 • 1 year	0.00% 0/60 • 1 year

Other adverse events

Other adverse events
Measure	Treatment As Usual (TAU) n=60 participants at risk We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.	Contingency Management Plus Stepped Care (Step 2) n=60 participants at risk Step 1: Contingency management (CM); Step 2: Addiction physician management and motivational enhancement therapy We provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth \> 8 ng/ml will continue on to Step 2. Contingency Management Counseling: CM is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence. Addiction Physician Management: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs. Motivational Enhancement Therapy: Patients in the CM plus stepped care arm who have PEth \> 8 ng/ml at 3 months will progress to Step 2 and receive onsite MotivationalEnhancement Therapy (MET) from the Social Worker (SW) in the HIV clinic. The SW's role is to assist the patient in moving through the stages of change using motivational interviewing and reflective listening to help patients identify internal motivation to reduce alcohol use.
General disorders Other AE	3.3% 2/60 • 1 year	3.3% 2/60 • 1 year
Psychiatric disorders Psychiatric AE	3.3% 2/60 • 1 year	0.00% 0/60 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory AE	0.00% 0/60 • 1 year	1.7% 1/60 • 1 year

Additional Information

Dr. David Fiellin

Yale University

Phone: 203-737-3347

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place