NCT05560932

HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1

Completed NA Results posted Last updated 4 July 2025

What this trial tests

NA trial testing IMB-motivational interviewing (MI) techniques (IMB-MI) in HIV in 50 participants. Completed in 4 January 2024.

Timeline

6 March 2023

Primary endpoint
4 January 2024

4 January 2024

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	6 March 2023
Primary completion	4 January 2024
Estimated completion	4 January 2024
Sites	1 location across United States

Drugs / interventions tested

• IMB-motivational interviewing (MI) techniques (IMB-MI)

Conditions studied

• HIV — all drugs for HIV →
• Alcohol Use — all drugs for Alcohol Use →

Sponsor

Yale University

Who can join

18 and older, any sex, with HIV or Alcohol Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Enrollment to Assess Feasibility Primary · baseline

Number of participants that enrolled and provided informed consent

Group	Value	95% CI
HIV Medications and Alcohol Use	50

Completion to Assess Feasibility Primary · Study completion (Post-intervention Day 30)

Number of participants that completed the full pilot intervention

Group	Value	95% CI
HIV Medications and Alcohol Use	35

Qualitative Interviews to Assess Feasibility Primary · Study completion (within one to four weeks after Post-intervention Day 30)

Number of participants that successfully completed the qualitative interviews

Group	Value	95% CI
HIV Medications and Alcohol Use	20

Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index Primary · 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.

Symptoms with improvement from baseline to post intervention Day 1.

Group	Value	95% CI
HIV Medications and Alcohol Use	1

Symptoms with improvement from baseline to post-intervention Day 30.

Group	Value	95% CI
HIV Medications and Alcohol Use	5

Number of Participants That Completed Both PEth Tests to Assess Acceptability. Primary · 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.

Group	Value	95% CI
HIV Medications and Alcohol Use	35

Participants Readiness to Change Prescribed Medications Primary · 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.

Readiness at baseline

Group	Value	95% CI
HIV Medications and Alcohol Use	6.9	± 3.5

Readiness immediately post intervention (day 1)

Group	Value	95% CI
HIV Medications and Alcohol Use	7.7	± 3.2

Readiness Post-intervention Day 30

Group	Value	95% CI
HIV Medications and Alcohol Use	7.1	± 3.7

Importance at baseline

Group	Value	95% CI
HIV Medications and Alcohol Use	7.7	± 3.2

Importance immediately post intervention (day 1)

Group	Value	95% CI
HIV Medications and Alcohol Use	7.5	± 3.3

Importance Post-intervention Day 30

Group	Value	95% CI
HIV Medications and Alcohol Use	7.0	± 3.6

Confidence at baseline

Group	Value	95% CI
HIV Medications and Alcohol Use	6.9	± 3.4

Confidence immediately post intervention (day 1)

Group	Value	95% CI
HIV Medications and Alcohol Use	7.5	± 3.5

Participants Readiness to Change Alcohol Use Primary · 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.

Readiness at baseline

Group	Value	95% CI
HIV Medications and Alcohol Use	6.4	± 3.4

Readiness immediately post intervention (day 1)

Group	Value	95% CI
HIV Medications and Alcohol Use	7.8	± 3.4

Readiness Post-intervention Day 30

Group	Value	95% CI
HIV Medications and Alcohol Use	7.0	± 3.7

Importance at baseline

Group	Value	95% CI
HIV Medications and Alcohol Use	6.1	± 3.8

Importance immediately post intervention (day 1)

Group	Value	95% CI
HIV Medications and Alcohol Use	7.6	± 3.4

Importance Post-intervention Day 30

Group	Value	95% CI
HIV Medications and Alcohol Use	6.83	± 3.8

Confidence at baseline

Group	Value	95% CI
HIV Medications and Alcohol Use	8.4	± 2.5

Confidence immediately post intervention (day 1)

Group	Value	95% CI
HIV Medications and Alcohol Use	8.9	± 2.5

Medication Use to Assess Acceptability Primary · 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.

Felt comfortable with the way medication information was presented

Group	Value	95% CI
HIV Medications and Alcohol Use	23

Understood the information given

Group	Value	95% CI
HIV Medications and Alcohol Use	35

Found the information helpful

Group	Value	95% CI
HIV Medications and Alcohol Use	31

Felt the amount of information was adequate

Group	Value	95% CI
HIV Medications and Alcohol Use	32

felt the information that they received was clear

Group	Value	95% CI
HIV Medications and Alcohol Use	33

Information Regarding PEth to Assess Acceptability Primary · 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.

Felt comfortable with the way PEth information was presented

Group	Value	95% CI
HIV Medications and Alcohol Use	25

Understood the information given

Group	Value	95% CI
HIV Medications and Alcohol Use	29

Found the information helpful

Group	Value	95% CI
HIV Medications and Alcohol Use	27

Felt the amount of information was adequate

Group	Value	95% CI
HIV Medications and Alcohol Use	6

Felt the information that they received was clear

Group	Value	95% CI
HIV Medications and Alcohol Use	30

General Feedback to Assess Acceptability Primary · 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.

Felt they learned new things about their health risk from alcohol

Group	Value	95% CI
HIV Medications and Alcohol Use	19

Learned new things about their health risk from polypharmacy

Group	Value	95% CI
HIV Medications and Alcohol Use	29

Learned how medications and alcohol can act together

Group	Value	95% CI
HIV Medications and Alcohol Use	30

Felt that having a pharmacist to talk with was helpful

Group	Value	95% CI
HIV Medications and Alcohol Use	23

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HIV Medications and Alcohol Use

Serious: 0/38 (0%)

Deaths: 0/38

Other adverse events (1 terms — click to expand)

Reaction	System	HIV Medications and Alcoho…
General disorders and administration site conditions - Other, specify	General disorders	—

Data from ClinicalTrials.gov NCT05560932 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Feasibility and Acceptability of a Clinical Pharmacist-delivered Intervention to Reduce Bothersome Health Symptoms from Polypharmacy and Alcohol Use and Communicate Risk among People with HIV: Pilot Study Protocol.
   Womack JA, Leblanc MM, Sager AS, Zaets LN, et al · · 2025 · cited 2× · PMID 39465468 · DOI 10.1007/s10461-024-04533-6