Alcohol Use, HIV, Medication Adherence
Conditions
Keywords
alcohol use, hazardous drinking, behavioral intervention, ART adherence, viral load, CD4
Brief summary
Alcohol use is increasingly recognized as a key factor in morbidity and mortality among HIV-positive individuals and represents an important public health concern, given its associations with medication non-adherence, increases in viral load, poor immunologic outcomes (lower cluster of differentiation 4, or CD4, counts), drug resistance, lower health care utilization, comorbidities (HIV/viral hepatitis coinfection), and poor health outcomes overall. Adherence to HIV medications has a double public health benefit, both in terms of slowing disease progression and improving health outcomes among HIV-positive individuals and in helping to curb the sexual transmission of HIV. The objective of this study is to implement a multisite comparative effectiveness trial in real-world clinical settings with three intensities of treatment to test the clinical and cost effectiveness of an efficacious, theory-based behavioral intervention (PLUS) in improving adherence to antiretroviral therapy (ART) and alcohol-related outcomes among HIV-positive individuals who drink alcohol at harmful or hazardous levels. The study is being conducted in collaboration between the Center for HIV Educational Studies and Training (CHEST) at Hunter College at the City University of New York (CUNY) and the Spencer Cox Center for Health at the Institute for Advanced Medicine, Mount Sinai Health System.
Detailed description
Alcohol consumption at harmful or hazardous levels among HIV-positive persons exacerbates health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) has been the single most important treatment for people living with HIV to optimize viral suppression and slow disease progression. Adherence to ART has considerable public health implications, particularly given that optimal adherence decreases morbidity and mortality, decreases the potential for the development of drug resistant strains of HIV, and reduces HIV infectiousness. Project PLUS (Positive Living through Understanding and Support) was the first (and to our knowledge only) theory-based behavioral intervention, which integrates motivational interviewing and cognitive-behavioral skills training, to demonstrate significant improvements in viral load, CD4 cell count, and self-reported adherence among a racially and ethnically diverse sample of HIV-positive women and men enrolled in a randomized controlled trial, and the first intervention for hazardous drinkers to demonstrate any significant effects. A clinic-based replication is the crucial next step in studying the intervention's effectiveness in the real world when delivered by HIV clinic providers to their patients. In collaboration with medical providers at the Spencer Cox Center for Health at the Institute for Advanced Medicine, Mount Sinai Health System, the largest provider of HIV medical care in the New York City area, our goals are to better understand alcohol-related outcomes among HIV-positive persons over the lifespan and to conduct a multisite comparative effectiveness trial with three intensities of treatment-the PLUS intervention, an enhanced treatment as usual (eTAU) condition, and treatment as usual (TAU) condition-to test the clinical and cost-effectiveness of the PLUS intervention in reducing alcohol use and improving ART adherence, viral load, and CD4 counts among HIV-positive hazardous drinkers. This study has the potential to exert a sustained and powerful impact on the effectiveness of ART interventions for HIV-positive persons with problematic drinking.
Interventions
BEHAVIORALImmediate PLUS intervention
The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.
BEHAVIORALWait-list PLUS intervention
In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Hunter College of City University of New York
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* HIV-positive * Currently receiving ART * Current viral load (VL) ˃200 copies/ml * Report drinking at hazardous levels, operationalized as exceeding 14 standard drinks per week for men or exceeding 7 standard drinks per week for women, or reported use of illicit drugs exclusive of marijuana or illicit use of prescription opioids within the past 3 months.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load | most recent result within past 90 days | Standard of care HIV-1 viral load results were run using local laboratories and results were abstracted from EMR data, indicating the participant's most recent viral load result. Each viral load result indicates the number of HIV copies in a milliliter (copies/mL), and raw values were log-transformed to deal with non-normal distribution. Minimum and maximum log-viral load values in the current sample were 1.28 and 6.07, respectively. |
| CD4 Count | most recent result within past 90 days | CD4 results were accessed through clinic EMR data, and represent cells per cubic millimeter. |
| ART Medication Adherence | past 30 days | Percentage of antiretroviral medication (ART) doses that were taken as prescribed, within the past 30 days. Minimum and maximum values were 0% and 100%, respectively. |
| Alcohol Use Severity | past 90 days | Severity of alcohol consumption as measured by the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a 10-item, widely-used screening questionnaire consisting of three questions related to drinking frequency, three questions on dependence, and four questions on problems caused by alcohol over the past three months. Scores range from 0 to 40, with higher scores indicating greater alcohol use. |
Countries
United States
Participant flow
Recruitment details
174 participants were enrolled in the experimental arms of PLUS. An additional 120 comparison patients, in regular care at sites but not enrolled in the study, had their electronic medical records (EMR) accessed. They were not considered enrolled in the study, as they did not sign informed consent, and did not receive intervention. Data for this No-Treatment EMR Control group included viral load, CD4 and demographics but not study measures (alcohol and drug use severity, medication adherence).
Participants by arm
| Arm | Count |
|---|---|
| Site 1 Immediate PLUS Intervention Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)
Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence. | 40 |
| Site 2 Immediate PLUS Intervention Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)
Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence. | 22 |
| Site 3 Immediate PLUS Intervention Immediate delivery of the PLUS intervention (Six sessions of Motivational Interviewing and Cognitive Behavioral Skills Training)
Immediate PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence. | 22 |
| Wait-list PLUS Condition Received the PLUS intervention at 12 months post baseline
PLUS intervention: The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.
Wait-list PLUS intervention: In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention. | 90 |
| No-Treatment EMR Control Group Patients whose electronic medical records (EMRs) were extracted for viral load and CD4 outcomes over the study period, but who were not enrolled in PLUS and did not receive the intervention. | 120 |
| Total | 294 |
Baseline characteristics
| Characteristic | Site 1 Immediate PLUS Intervention | Wait-list PLUS Condition | Site 3 Immediate PLUS Intervention | No-Treatment EMR Control Group | Total | Site 2 Immediate PLUS Intervention |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 6 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 87 Participants | 22 Participants | 119 Participants | 288 Participants | 21 Participants |
| Age, Continuous | 45.2 years STANDARD_DEVIATION 11.5 | 45.5 years STANDARD_DEVIATION 11.9 | 44.0 years STANDARD_DEVIATION 10.2 | 45.2 years STANDARD_DEVIATION 10.7 | 44.9 years STANDARD_DEVIATION 11.2 | 41.2 years STANDARD_DEVIATION 11.3 |
| Drug Use DAST Score | 4.1 units on a scale STANDARD_DEVIATION 2.7 | 3.74 units on a scale STANDARD_DEVIATION 2.7 | 2.8 units on a scale STANDARD_DEVIATION 2.3 | — | 3.74 units on a scale STANDARD_DEVIATION 2.7 | 4.0 units on a scale STANDARD_DEVIATION 2.5 |
| Race/Ethnicity, Customized Race/Ethnicity Black | 18 Participants | 51 Participants | 15 Participants | 62 Participants | 156 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Latino | 8 Participants | 22 Participants | 3 Participants | 21 Participants | 62 Participants | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 7 Participants | 9 Participants | 1 Participants | 21 Participants | 42 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 7 Participants | 8 Participants | 3 Participants | 16 Participants | 34 Participants | 0 Participants |
| Region of Enrollment United States | 40 participants | 90 participants | 22 participants | 120 participants | 174 participants | 22 participants |
| Sex: Female, Male Female | 2 Participants | 20 Participants | 8 Participants | 21 Participants | 54 Participants | 3 Participants |
| Sex: Female, Male Male | 38 Participants | 70 Participants | 14 Participants | 99 Participants | 240 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 22 | 1 / 22 | 3 / 90 | 0 / 120 |
| other Total, other adverse events | 0 / 40 | 0 / 22 | 0 / 22 | 0 / 90 | 0 / 120 |
| serious Total, serious adverse events | 0 / 40 | 0 / 22 | 0 / 22 | 0 / 90 | 0 / 120 |
Outcome results
Primary
Alcohol Use Severity
Severity of alcohol consumption as measured by the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a 10-item, widely-used screening questionnaire consisting of three questions related to drinking frequency, three questions on dependence, and four questions on problems caused by alcohol over the past three months. Scores range from 0 to 40, with higher scores indicating greater alcohol use.
Time frame: past 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site 1 Immediate PLUS Intervention | Alcohol Use Severity | 10.38 score on a scale | Standard Deviation 6.6 |
| Site 2 Immediate PLUS Intervention | Alcohol Use Severity | 3.29 score on a scale | Standard Deviation 5.5 |
| Site 3 Immediate PLUS Intervention | Alcohol Use Severity | 9.05 score on a scale | Standard Deviation 9.6 |
| Wait-list PLUS Condition | Alcohol Use Severity | 5.93 score on a scale | Standard Deviation 6.3 |
p-value: 0.0295% CI: [0.61, 5.78]Latent Growth Curve
p-value: 0.6395% CI: [-4.33, 2.61]Latent Growth Curve
p-value: 0.0295% CI: [0.8, 7.54]Latent Growth Curve
p-value: 0.4695% CI: [-1.47, 0.67]Latent Growth Curve
p-value: 0.595% CI: [-1.12, 0.55]Latent Growth Curve
p-value: 0.4395% CI: [-1.23, 0.52]Latent Growth Curve
Primary
ART Medication Adherence
Percentage of antiretroviral medication (ART) doses that were taken as prescribed, within the past 30 days. Minimum and maximum values were 0% and 100%, respectively.
Time frame: past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site 1 Immediate PLUS Intervention | ART Medication Adherence | 85.5 percentage of adherent days | Standard Deviation 31.1 |
| Site 2 Immediate PLUS Intervention | ART Medication Adherence | 86.6 percentage of adherent days | Standard Deviation 15.8 |
| Site 3 Immediate PLUS Intervention | ART Medication Adherence | 83.4 percentage of adherent days | Standard Deviation 18.5 |
| Wait-list PLUS Condition | ART Medication Adherence | 77.6 percentage of adherent days | Standard Deviation 34 |
p-value: 0.2295% CI: [-20.52, 4.78]Latent Growth Curve
p-value: 0.2295% CI: [-6.25, 26.82]Latent Growth Curve
p-value: 0.9695% CI: [-11.63, 11.08]Latent Growth Curve
p-value: 0.0395% CI: [0.72, 11.97]Latent Growth Curve
p-value: 0.4295% CI: [-4.78, 11.47]Latent Growth Curve
p-value: 0.9195% CI: [-5.85, 6.54]Latent Growth Curve
Primary
CD4 Count
CD4 results were accessed through clinic EMR data, and represent cells per cubic millimeter.
Time frame: most recent result within past 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site 1 Immediate PLUS Intervention | CD4 Count | 632.4 number of cells per cubic milimeter | Standard Deviation 355.1 |
| Site 2 Immediate PLUS Intervention | CD4 Count | 696.2 number of cells per cubic milimeter | Standard Deviation 356.2 |
| Site 3 Immediate PLUS Intervention | CD4 Count | 390.5 number of cells per cubic milimeter | Standard Deviation 462.9 |
| Wait-list PLUS Condition | CD4 Count | 398.2 number of cells per cubic milimeter | Standard Deviation 252.2 |
| No-Treatment Control EMR Group | CD4 Count | 409.1 number of cells per cubic milimeter | Standard Deviation 254.7 |
p-value: 0.9595% CI: [-54.68, 58.53]Latent Growth Curve
p-value: 0.6195% CI: [-67.54, 115.51]Latent Growth Curve
p-value: 0.4895% CI: [-88.82, 41.4]Latent Growth Curve
p-value: 0.8895% CI: [-49.76, 58.14]Latent Growth Curve
p-value: 0.5995% CI: [-19.88, 35.21]Latent Growth Curve
p-value: 0.2495% CI: [-66.78, 16.88]Latent Growth Curve
p-value: 0.1595% CI: [-6.63, 43.27]Latent Growth Curve
p-value: 0.3395% CI: [-10.2, 30.74]Latent Growth Curve
p-value: 0.895% CI: [-44.24, 57.09]Latent Growth Curve
p-value: 0.8995% CI: [-85.47, 74.61]Latent Growth Curve
p-value: 0.9795% CI: [-60.61, 62.94]Latent Growth Curve
p-value: 0.0795% CI: [-79.51, 2.72]Latent Growth Curve
Primary
Viral Load
Standard of care HIV-1 viral load results were run using local laboratories and results were abstracted from EMR data, indicating the participant's most recent viral load result. Each viral load result indicates the number of HIV copies in a milliliter (copies/mL), and raw values were log-transformed to deal with non-normal distribution. Minimum and maximum log-viral load values in the current sample were 1.28 and 6.07, respectively.
Time frame: most recent result within past 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site 1 Immediate PLUS Intervention | Viral Load | 3.1 Log-transformed copies per. milimeter | Standard Deviation 1.7 |
| Site 2 Immediate PLUS Intervention | Viral Load | 1.8 Log-transformed copies per. milimeter | Standard Deviation 1 |
| Site 3 Immediate PLUS Intervention | Viral Load | 1.8 Log-transformed copies per. milimeter | Standard Deviation 0.6 |
| Wait-list PLUS Condition | Viral Load | 2.6 Log-transformed copies per. milimeter | Standard Deviation 1.4 |
| No-Treatment Control EMR Group | Viral Load | 2.5 Log-transformed copies per. milimeter | Standard Deviation 1.4 |
p-value: 0.3995% CI: [-0.28, 0.72]Latent Growth Curve
p-value: 0.9495% CI: [-0.84, 0.79]Latent Growth Curve
p-value: 0.9595% CI: [-0.69, 0.74]Latent Growth Curve
p-value: 0.0995% CI: [-0.69, 0.05]Latent Growth Curve
p-value: 0.7995% CI: [-0.24, 0.18]Latent Growth Curve
p-value: 0.5795% CI: [-0.53, 0.36]Latent Growth Curve
p-value: 0.9795% CI: [-0.35, 0.36]Latent Growth Curve
p-value: 0.4195% CI: [-0.1, 0.24]Latent Growth Curve
p-value: 0.8295% CI: [-0.41, 0.52]Latent Growth Curve
p-value: 0.4995% CI: [-0.26, 0.53]Latent Growth Curve
p-value: 0.1895% CI: [-0.8, 0.15]Latent Growth Curve
p-value: 0.8995% CI: [-0.28, 0.32]Latent Growth Curve