Trial results for a pilot study investigating HIV and alcohol polypharmacy were posted on ClinicalTrials.gov on 2025-07-04, with 50 participants enrolled.
Background
HIV management often involves complex polypharmacy, where patients take multiple medications. For individuals living with HIV who also consume alcohol, there is a significant concern regarding potential interactions between alcohol and prescribed medications. These interactions can lead to serious adverse outcomes, including bothersome symptoms, which can impact treatment adherence and overall quality of life. This pilot study aimed to explore the feasibility of an intervention addressing these issues in patients with HIV taking five or more medications and currently consuming alcohol.
Trial design
This completed pilot study, designated as Phase NA, enrolled 50 participants. The trial focused on individuals with HIV and Alcohol Use who were taking five or more medications. The intervention consisted of a brief session aimed at addressing bothersome symptoms and the impact of alcohol use and medications on these symptoms. The rationale for the intervention was to mitigate serious interactions between alcohol and medications that could lead to adverse outcomes.
Key results
The trial reported several key measurements related to feasibility and participant responses:
- Enrollment to Assess Feasibility: 50 Participants
- Completion to Assess Feasibility: 35 Participants
- Qualitative Interviews to Assess Feasibility: 20 Participants
- Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index:
- 1 symptoms
- 5 symptoms
- Number of Participants That Completed Both PEth Tests to Assess Acceptability: 35 Participants
- Participants Readiness to Change Prescribed Medications (score on a scale):
- Mean 6.9 (Standard Deviation 3.5)
- Mean 7.7 (Standard Deviation 3.2)
- Mean 7.1 (Standard Deviation 3.7)
- Mean 7.7 (Standard Deviation 3.2)
- Mean 7.5 (Standard Deviation 3.3)
- Mean 7.0 (Standard Deviation 3.6)
What this means
The posted results provide initial data on the feasibility and acceptability of a brief intervention for individuals with HIV managing polypharmacy and alcohol use. The enrollment of 50 participants and completion by 35 participants indicates a level of feasibility for such an intervention. The collection of qualitative interviews from 20 participants and completion of PEth tests by 35 participants further supports the acceptability of the study procedures. While preliminary changes in bothersome symptoms and readiness to change prescribed medications were measured, these pilot findings primarily serve to inform the design and implementation of larger, more definitive studies on this complex patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05560932, titled "HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1", were posted on 2025-07-04 on clinicaltrials.gov.