N/A
Completed N=38
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1
Source: ClinicalTrials.gov NCT05560932 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Enrollment to Assess Feasibility — 50 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrollment to Assess Feasibility |
50 | — |
| PRIMARY Completion to Assess Feasibility |
35 | — |
| PRIMARY Qualitative Interviews to Assess Feasibility |
20 | — |
| PRIMARY Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index |
1; 5 | — |
| PRIMARY Number of Participants That Completed Both PEth Tests to Assess Acceptability. |
35 | — |
| PRIMARY Participants Readiness to Change Prescribed Medications |
6.9; 7.7; 7.1; 7.7; 7.5; 7.0 | — |
| PRIMARY Participants Readiness to Change Alcohol Use |
6.4; 7.8; 7.0; 6.1; 7.6; 6.83 | — |
| PRIMARY Medication Use to Assess Acceptability |
23; 35; 31; 32; 33 | — |
| PRIMARY Information Regarding PEth to Assess Acceptability |
25; 29; 27; 6; 30 | — |
| PRIMARY General Feedback to Assess Acceptability |
19; 29; 30; 23 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05560932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.