HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1
- Conditions
- Alcohol UseHIV
- Registration Number
- NCT05560932
- Lead Sponsor
- Yale University
- Brief 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.
- Detailed Description
Additional outcomes were added at results entry.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Enrollment to Assess Feasibility baseline Number of participants that enrolled and provided informed consent
Completion to Assess Feasibility Study completion (Post-intervention Day 30) Number of participants that completed the full pilot intervention
Qualitative Interviews to Assess Feasibility Study completion (within one to four weeks after Post-intervention Day 30) Number of participants that successfully completed the qualitative interviews
Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index 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.
Number of Participants That Completed Both PEth Tests to Assess Acceptability. 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.
Participants Readiness to Change Alcohol Use 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.
Medication Use to Assess Acceptability 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.
Participants Readiness to Change Prescribed Medications 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.
Information Regarding PEth to Assess Acceptability 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.
General Feedback to Assess Acceptability 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West Haven CT Veterans Administration
🇺🇸West Haven, Connecticut, United States
West Haven CT Veterans Administration🇺🇸West Haven, Connecticut, United States