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

Primary outcomes

1. Enrollment to Assess Feasibility

   Time frame: baseline

   Number of participants that enrolled and provided informed consent

2. Completion to Assess Feasibility

   Time frame: Study completion (Post-intervention Day 30)

   Number of participants that completed the full pilot intervention

3. Qualitative Interviews to Assess Feasibility

   Time frame: Study completion (within one to four weeks after Post-intervention Day 30)

   Number of participants that successfully completed the qualitative interviews

4. Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index

   Time frame: 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.

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

   Time frame: 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.

6. Participants Readiness to Change Prescribed Medications

   Time frame: 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.

7. Participants Readiness to Change Alcohol Use

   Time frame: 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.

8. Medication Use to Assess Acceptability

   Time frame: 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.

9. Information Regarding PEth to Assess Acceptability

   Time frame: 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.

10. General Feedback to Assess Acceptability

    Time frame: 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.