Alcohol Use, HIV
Conditions
Brief summary
This pilot intervention will consist of a brief intervention for patients with HIV who take 5 or more medications and currently (within the past month) consume alcohol. The focus of this pilot will be on bothersome symptoms and the impact of alcohol use and medications on these symptoms. The rationale is that any alcohol use may interact with medications in serious ways leading to adverse outcomes, including bothersome symptoms.
Detailed description
Additional outcomes were added at results entry.
Interventions
BEHAVIORALIMB-motivational interviewing (MI) techniques (IMB-MI)
The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care).
Sponsors
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* participants in both Veterans Aging Cohort Study (VACS) and Medications, Alcohol, and Substance use in HIV (MASH) studies * prescribed 5 or more medications AND who either have a positive PEth value (8+) or a self-reported AUDIT-C value consistent with current alcohol use (score \>0)
Exclusion criteria
* Alcohol use disorder (AUD) diagnosis in the past 12 months or who test positive for AUD on the Alcohol Symptom Checklist for moderate or severe AUD (score of 4 or more)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment to Assess Feasibility | baseline | Number of participants that enrolled and provided informed consent |
| Completion to Assess Feasibility | Study completion (Post-intervention Day 30) | Number of participants that completed the full pilot intervention |
| Qualitative Interviews to Assess Feasibility | Study completion (within one to four weeks after Post-intervention Day 30) | Number of participants that successfully completed the qualitative interviews |
| Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index | baseline, post-intervention Day 1, Post-intervention Day 30 | The HIV Symptoms Index is a 20-item, self-reported measure that assesses presence and perceived distress linked to symptoms associated with HIV or HIV treatment. There are 5 possible responses: 0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot, for each HIV symptom. Presented here is the number of bothersome symptoms with improvement on post-intervention Day 1 and post-intervention Day 30. |
| Number of Participants That Completed Both PEth Tests to Assess Acceptability. | baseline and Post-intervention Day 30 | Change in alcohol levels assessed measuring PEth levels in the blood. PEth testing uses blood to measure alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test indicates alcohol use. |
| Participants Readiness to Change Prescribed Medications | baseline, immediately post intervention (day 1) and Post-intervention Day 30 | The mean score of participants responses by self report. Participants were asked "If your provider felt it was a good idea, how ready are you to decrease your medications?", "If your provider felt it was a good idea, how important is it for you to decrease your medications?", and "If your provider felt it was a good idea, how confident are you that you can decrease your medications?" Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes. |
| Participants Readiness to Change Alcohol Use | baseline, immediately post intervention (day 1) and Post-intervention Day 30 | The mean score of participants responses by self report. Participants were asked "If your provider felt it was a good idea, how ready are you to decrease your alcohol use?", "If your provider felt it was a good idea, how important is it for you to decrease your alcohol use?", and "If your provider felt it was a good idea, how confident are you that you can decrease your alcohol use?" Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes. |
| Medication Use to Assess Acceptability | Post-intervention Day 30 | The number of respondents who reported they (1) felt comfortable with the way medication information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5. |
| Information Regarding PEth to Assess Acceptability | Post-intervention Day 30 | The number of respondents who reported that they (1) felt comfortable with the way PEth information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5. |
| General Feedback to Assess Acceptability | Post-intervention Day 30 | The number of respondents who (1) felt they learned new things about their health risk from alcohol, (2) learned new things about their health risk from polypharmacy, (3) learned how medications and alcohol can act together, and (4) felt that having a pharmacist to talk with was helpful. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy C Justice, MD, PhD
Yale University
Participant flow
Pre-assignment details
50 enrolled, 12 did not complete any study activities, 38 started and received intervention
Participants by arm
| Arm | Count |
|---|---|
| HIV Medications and Alcohol Use Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol
IMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care). | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | HIV Medications and Alcohol Use |
|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 8.1 |
| Education College Graduate | 11 Participants |
| Education High School Graduate | 14 Participants |
| Education Some College | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 1 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index
The HIV Symptoms Index is a 20-item, self-reported measure that assesses presence and perceived distress linked to symptoms associated with HIV or HIV treatment. There are 5 possible responses: 0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot, for each HIV symptom. Presented here is the number of bothersome symptoms with improvement on post-intervention Day 1 and post-intervention Day 30.
Time frame: baseline, post-intervention Day 1, Post-intervention Day 30
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV Medications and Alcohol Use | Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index | Symptoms with improvement from baseline to post intervention Day 1. | 1 symptoms |
| HIV Medications and Alcohol Use | Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index | Symptoms with improvement from baseline to post-intervention Day 30. | 5 symptoms |
Primary
Completion to Assess Feasibility
Number of participants that completed the full pilot intervention
Time frame: Study completion (Post-intervention Day 30)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Medications and Alcohol Use | Completion to Assess Feasibility | 35 Participants |
Primary
Enrollment to Assess Feasibility
Number of participants that enrolled and provided informed consent
Time frame: baseline
Population: 50 participants were enrolled. 12 did not complete any study activities.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Medications and Alcohol Use | Enrollment to Assess Feasibility | 50 Participants |
Primary
General Feedback to Assess Acceptability
The number of respondents who (1) felt they learned new things about their health risk from alcohol, (2) learned new things about their health risk from polypharmacy, (3) learned how medications and alcohol can act together, and (4) felt that having a pharmacist to talk with was helpful. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.
Time frame: Post-intervention Day 30
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Medications and Alcohol Use | General Feedback to Assess Acceptability | Felt they learned new things about their health risk from alcohol | 19 Participants |
| HIV Medications and Alcohol Use | General Feedback to Assess Acceptability | Learned new things about their health risk from polypharmacy | 29 Participants |
| HIV Medications and Alcohol Use | General Feedback to Assess Acceptability | Learned how medications and alcohol can act together | 30 Participants |
| HIV Medications and Alcohol Use | General Feedback to Assess Acceptability | Felt that having a pharmacist to talk with was helpful | 23 Participants |
Primary
Information Regarding PEth to Assess Acceptability
The number of respondents who reported that they (1) felt comfortable with the way PEth information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.
Time frame: Post-intervention Day 30
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Medications and Alcohol Use | Information Regarding PEth to Assess Acceptability | Felt comfortable with the way PEth information was presented | 25 Participants |
| HIV Medications and Alcohol Use | Information Regarding PEth to Assess Acceptability | Understood the information given | 29 Participants |
| HIV Medications and Alcohol Use | Information Regarding PEth to Assess Acceptability | Found the information helpful | 27 Participants |
| HIV Medications and Alcohol Use | Information Regarding PEth to Assess Acceptability | Felt the amount of information was adequate | 6 Participants |
| HIV Medications and Alcohol Use | Information Regarding PEth to Assess Acceptability | Felt the information that they received was clear | 30 Participants |
Primary
Medication Use to Assess Acceptability
The number of respondents who reported they (1) felt comfortable with the way medication information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.
Time frame: Post-intervention Day 30
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HIV Medications and Alcohol Use | Medication Use to Assess Acceptability | Felt comfortable with the way medication information was presented | 23 Participants |
| HIV Medications and Alcohol Use | Medication Use to Assess Acceptability | Understood the information given | 35 Participants |
| HIV Medications and Alcohol Use | Medication Use to Assess Acceptability | Found the information helpful | 31 Participants |
| HIV Medications and Alcohol Use | Medication Use to Assess Acceptability | Felt the amount of information was adequate | 32 Participants |
| HIV Medications and Alcohol Use | Medication Use to Assess Acceptability | felt the information that they received was clear | 33 Participants |
Primary
Number of Participants That Completed Both PEth Tests to Assess Acceptability.
Change in alcohol levels assessed measuring PEth levels in the blood. PEth testing uses blood to measure alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test indicates alcohol use.
Time frame: baseline and Post-intervention Day 30
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Medications and Alcohol Use | Number of Participants That Completed Both PEth Tests to Assess Acceptability. | 35 Participants |
Primary
Participants Readiness to Change Alcohol Use
The mean score of participants responses by self report. Participants were asked If your provider felt it was a good idea, how ready are you to decrease your alcohol use?, If your provider felt it was a good idea, how important is it for you to decrease your alcohol use?, and If your provider felt it was a good idea, how confident are you that you can decrease your alcohol use? Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes.
Time frame: baseline, immediately post intervention (day 1) and Post-intervention Day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Readiness at baseline | 6.4 score on a scale | Standard Deviation 3.4 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Readiness immediately post intervention (day 1) | 7.8 score on a scale | Standard Deviation 3.4 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Readiness Post-intervention Day 30 | 7.0 score on a scale | Standard Deviation 3.7 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Importance at baseline | 6.1 score on a scale | Standard Deviation 3.8 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Importance immediately post intervention (day 1) | 7.6 score on a scale | Standard Deviation 3.4 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Importance Post-intervention Day 30 | 6.83 score on a scale | Standard Deviation 3.8 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Confidence at baseline | 8.4 score on a scale | Standard Deviation 2.5 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Confidence immediately post intervention (day 1) | 8.9 score on a scale | Standard Deviation 2.5 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Alcohol Use | Confidence Post-intervention Day 30 | 8.7 score on a scale | Standard Deviation 2.4 |
Primary
Participants Readiness to Change Prescribed Medications
The mean score of participants responses by self report. Participants were asked If your provider felt it was a good idea, how ready are you to decrease your medications?, If your provider felt it was a good idea, how important is it for you to decrease your medications?, and If your provider felt it was a good idea, how confident are you that you can decrease your medications? Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes.
Time frame: baseline, immediately post intervention (day 1) and Post-intervention Day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Readiness at baseline | 6.9 score on a scale | Standard Deviation 3.5 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Readiness immediately post intervention (day 1) | 7.7 score on a scale | Standard Deviation 3.2 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Readiness Post-intervention Day 30 | 7.1 score on a scale | Standard Deviation 3.7 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Importance at baseline | 7.7 score on a scale | Standard Deviation 3.2 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Importance Post-intervention Day 30 | 7.0 score on a scale | Standard Deviation 3.6 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Confidence at baseline | 6.9 score on a scale | Standard Deviation 3.4 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Confidence immediately post intervention (day 1) | 7.5 score on a scale | Standard Deviation 3.5 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Confidence Post-intervention Day 30 | 7.7 score on a scale | Standard Deviation 3.3 |
| HIV Medications and Alcohol Use | Participants Readiness to Change Prescribed Medications | Importance immediately post intervention (day 1) | 7.5 score on a scale | Standard Deviation 3.3 |
Primary
Qualitative Interviews to Assess Feasibility
Number of participants that successfully completed the qualitative interviews
Time frame: Study completion (within one to four weeks after Post-intervention Day 30)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HIV Medications and Alcohol Use | Qualitative Interviews to Assess Feasibility | 20 Participants |