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| ID | Type | Description | Link |
|---|---|---|---|
| P01AA029545-03 | U.S. NIH Grant/Contract | View source | |
| P01 AA029545-03 sub 9238 | Other Grant/Funding Number | Sub Award P01 AA029545-03 |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
Additional outcomes were added at results entry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV Medications and Alcohol Use | Experimental | Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMB-motivational interviewing (MI) techniques (IMB-MI) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment to Assess Feasibility | Number of participants that enrolled and provided informed consent | baseline |
| Completion to Assess Feasibility | Number of participants that completed the full pilot intervention | Study completion (Post-intervention Day 30) |
| Qualitative Interviews to Assess Feasibility | Number of participants that successfully completed the qualitative interviews | Study completion (within one to four weeks after Post-intervention Day 30) |
| 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. | baseline, post-intervention Day 1, Post-intervention Day 30 |
| 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. | baseline and Post-intervention Day 30 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy C Justice, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Haven CT Veterans Administration | West Haven | Connecticut | 06516 | United States |
The data will not be shared by placing it in a data repository, but will be shared with those who submit a reasonable request .
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50 enrolled, 12 did not complete any study activities, 38 started and received intervention
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Enrollment to Assess Feasibility | Number of participants that enrolled and provided informed consent | 50 participants were enrolled. 12 did not complete any study activities. | Posted | Count of Participants | Participants | baseline |
|
2 months
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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 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions - Other, specify | General disorders | Non-systematic Assessment | Patient left study temporarily for health reasons prior to intervention activities, then returned to participate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy C Justice, MD, PhD | Yale University | 203-932-5711 | 3541 | amy.justice2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2022 | Dec 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2025 | May 14, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 10, 2023 | Dec 12, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| baseline, immediately post intervention (day 1) and Post-intervention Day 30 |
| 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. | baseline, immediately post intervention (day 1) and Post-intervention Day 30 |
| 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. | Post-intervention Day 30 |
| 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. | Post-intervention Day 30 |
| 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. | Post-intervention Day 30 |
| 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 |
|
| Education | Count of Participants | Participants |
|
|
|
| Primary | Completion to Assess Feasibility | Number of participants that completed the full pilot intervention | Posted | Count of Participants | Participants | Study completion (Post-intervention Day 30) |
|
|
|
| Primary | Qualitative Interviews to Assess Feasibility | Number of participants that successfully completed the qualitative interviews | Posted | Count of Participants | Participants | Study completion (within one to four weeks after Post-intervention Day 30) |
|
|
|
| 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. | Posted | Number | symptoms | baseline, post-intervention Day 1, Post-intervention Day 30 |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline and Post-intervention Day 30 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately post intervention (day 1) and Post-intervention Day 30 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, immediately post intervention (day 1) and Post-intervention Day 30 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Post-intervention Day 30 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Post-intervention Day 30 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Post-intervention Day 30 |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 1 |
| 38 |
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| Importance at baseline |
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| Importance immediately post intervention (day 1) |
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| Importance Post-intervention Day 30 |
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| Confidence at baseline |
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| Confidence immediately post intervention (day 1) |
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| Confidence Post-intervention Day 30 |
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| Importance at baseline |
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| Importance immediately post intervention (day 1) |
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| Importance Post-intervention Day 30 |
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| Confidence at baseline |
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| Confidence immediately post intervention (day 1) |
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| Confidence Post-intervention Day 30 |
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| Title | Measurements |
|---|---|
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| Felt the amount of information was adequate |
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| felt the information that they received was clear |
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| Title | Measurements |
|---|---|
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| Felt the amount of information was adequate |
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| Felt the information that they received was clear |
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| Felt that having a pharmacist to talk with was helpful |
|