Trial Outcomes & Findings for HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1 (NCT NCT05560932)
NCT ID: NCT05560932
Last Updated: 2025-07-04
Results Overview
Number of participants that enrolled and provided informed consent
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
baseline
Results posted on
2025-07-04
Participant Flow
50 enrolled, 12 did not complete any study activities, 38 started and received intervention
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
Intervention Only
|
3
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1
Baseline characteristics by cohort
| Measure |
HIV Medications and Alcohol Use
n=38 Participants
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).
|
|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
|
Education
High School Graduate
|
14 Participants
n=5 Participants
|
|
Education
Some College
|
13 Participants
n=5 Participants
|
|
Education
College Graduate
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: 50 participants were enrolled. 12 did not complete any study activities.
Number of participants that enrolled and provided informed consent
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=50 Participants
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).
|
|---|---|
|
Enrollment to Assess Feasibility
|
50 Participants
|
PRIMARY outcome
Timeframe: Study completion (Post-intervention Day 30)Number of participants that completed the full pilot intervention
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=38 Participants
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).
|
|---|---|
|
Completion to Assess Feasibility
|
35 Participants
|
PRIMARY outcome
Timeframe: Study completion (within one to four weeks after Post-intervention Day 30)Number of participants that successfully completed the qualitative interviews
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=38 Participants
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).
|
|---|---|
|
Qualitative Interviews to Assess Feasibility
|
20 Participants
|
PRIMARY outcome
Timeframe: baseline, post-intervention Day 1, Post-intervention Day 30The 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.
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=35 Participants
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).
|
|---|---|
|
Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index
Symptoms with improvement from baseline to post intervention Day 1.
|
1 symptoms
|
|
Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index
Symptoms with improvement from baseline to post-intervention Day 30.
|
5 symptoms
|
PRIMARY outcome
Timeframe: baseline and Post-intervention Day 30Change 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.
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=38 Participants
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).
|
|---|---|
|
Number of Participants That Completed Both PEth Tests to Assess Acceptability.
|
35 Participants
|
PRIMARY outcome
Timeframe: baseline, immediately post intervention (day 1) and Post-intervention Day 30The 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.
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=38 Participants
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).
|
|---|---|
|
Participants Readiness to Change Prescribed Medications
Readiness at baseline
|
6.9 score on a scale
Standard Deviation 3.5
|
|
Participants Readiness to Change Prescribed Medications
Readiness immediately post intervention (day 1)
|
7.7 score on a scale
Standard Deviation 3.2
|
|
Participants Readiness to Change Prescribed Medications
Readiness Post-intervention Day 30
|
7.1 score on a scale
Standard Deviation 3.7
|
|
Participants Readiness to Change Prescribed Medications
Importance at baseline
|
7.7 score on a scale
Standard Deviation 3.2
|
|
Participants Readiness to Change Prescribed Medications
Importance immediately post intervention (day 1)
|
7.5 score on a scale
Standard Deviation 3.3
|
|
Participants Readiness to Change Prescribed Medications
Importance Post-intervention Day 30
|
7.0 score on a scale
Standard Deviation 3.6
|
|
Participants Readiness to Change Prescribed Medications
Confidence at baseline
|
6.9 score on a scale
Standard Deviation 3.4
|
|
Participants Readiness to Change Prescribed Medications
Confidence immediately post intervention (day 1)
|
7.5 score on a scale
Standard Deviation 3.5
|
|
Participants Readiness to Change Prescribed Medications
Confidence Post-intervention Day 30
|
7.7 score on a scale
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: baseline, immediately post intervention (day 1) and Post-intervention Day 30The 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.
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=38 Participants
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).
|
|---|---|
|
Participants Readiness to Change Alcohol Use
Readiness at baseline
|
6.4 score on a scale
Standard Deviation 3.4
|
|
Participants Readiness to Change Alcohol Use
Readiness immediately post intervention (day 1)
|
7.8 score on a scale
Standard Deviation 3.4
|
|
Participants Readiness to Change Alcohol Use
Readiness Post-intervention Day 30
|
7.0 score on a scale
Standard Deviation 3.7
|
|
Participants Readiness to Change Alcohol Use
Importance at baseline
|
6.1 score on a scale
Standard Deviation 3.8
|
|
Participants Readiness to Change Alcohol Use
Importance immediately post intervention (day 1)
|
7.6 score on a scale
Standard Deviation 3.4
|
|
Participants Readiness to Change Alcohol Use
Importance Post-intervention Day 30
|
6.83 score on a scale
Standard Deviation 3.8
|
|
Participants Readiness to Change Alcohol Use
Confidence at baseline
|
8.4 score on a scale
Standard Deviation 2.5
|
|
Participants Readiness to Change Alcohol Use
Confidence immediately post intervention (day 1)
|
8.9 score on a scale
Standard Deviation 2.5
|
|
Participants Readiness to Change Alcohol Use
Confidence Post-intervention Day 30
|
8.7 score on a scale
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: Post-intervention Day 30The 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.
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=35 Participants
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).
|
|---|---|
|
Medication Use to Assess Acceptability
Felt comfortable with the way medication information was presented
|
23 Participants
|
|
Medication Use to Assess Acceptability
Understood the information given
|
35 Participants
|
|
Medication Use to Assess Acceptability
Found the information helpful
|
31 Participants
|
|
Medication Use to Assess Acceptability
Felt the amount of information was adequate
|
32 Participants
|
|
Medication Use to Assess Acceptability
felt the information that they received was clear
|
33 Participants
|
PRIMARY outcome
Timeframe: Post-intervention Day 30The 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.
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=35 Participants
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).
|
|---|---|
|
Information Regarding PEth to Assess Acceptability
Felt comfortable with the way PEth information was presented
|
25 Participants
|
|
Information Regarding PEth to Assess Acceptability
Understood the information given
|
29 Participants
|
|
Information Regarding PEth to Assess Acceptability
Found the information helpful
|
27 Participants
|
|
Information Regarding PEth to Assess Acceptability
Felt the amount of information was adequate
|
6 Participants
|
|
Information Regarding PEth to Assess Acceptability
Felt the information that they received was clear
|
30 Participants
|
PRIMARY outcome
Timeframe: Post-intervention Day 30The 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.
Outcome measures
| Measure |
HIV Medications and Alcohol Use
n=35 Participants
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).
|
|---|---|
|
General Feedback to Assess Acceptability
Felt they learned new things about their health risk from alcohol
|
19 Participants
|
|
General Feedback to Assess Acceptability
Learned new things about their health risk from polypharmacy
|
29 Participants
|
|
General Feedback to Assess Acceptability
Learned how medications and alcohol can act together
|
30 Participants
|
|
General Feedback to Assess Acceptability
Felt that having a pharmacist to talk with was helpful
|
23 Participants
|
Adverse Events
HIV Medications and Alcohol Use
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIV Medications and Alcohol Use
n=38 participants at risk
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).
|
|---|---|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.6%
1/38 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place