HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
NCT Number: NCT06513819
Acronym: HARP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hiv|Alcohol Drinking|Fall|Cannabis Use
Interventions: BEHAVIORAL: Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique
Sponsor: Yale University
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2025-08
Locations: VA Connecticut Healthcare System, West Haven, Connecticut, 06516, United States

Summary:
The focus of this pilot will be on falls and neurocognitive symptoms, and the impact of alcohol, cannabis use, and medications on these outcomes. The rationale is that alcohol use at any level may interact with neurocognitively active medications, alcohol, and cannabis use leading to falls and impaired cognition.

Primary Outcome Measures: Feasibility: Ability to meet enrollment target of 100 participants, Enrollment of 100 Participants: Week -2: Gather list of 100 eligible patients from the online VACS-HIV Index database; Send opt-out letter with study information and contact number. Week -2 to Week 0: Track patients for 2 weeks and note which have opted out. Week 0: Contact patients who have not opted-out; enroll, screen, and conduct medication reconciliation phone call; Send out pre-intervention package., Week -2 to Week 0|Feasibility: Ability to deliver the complete intervention, Week 3: 1-hour intervention call between VA clinical pharmacist and participant Week 7: 30-minute booster call between VA clinical pharmacist and participant, Week 3 and week 7|Feasibility:Percentage of Completion of Study Items, Percentage of completion of study items (Pre-Intervention Survey, Phosphatidylethanol Test, Post-Intervention Survey, 6-Month Post Intervention Survey, Phosphatidylethanol Test 2). Higher percentage indicates more completion of study items., up to Month 9|Acceptability: comfort, comprehensibility/helpfulness of content, Assessed using a series of multiple-choice feedback and open-ended questions on Post-Intervention Survey and 6-Month Post Intervention Survey and a series of prompts on final semi-structured interview focused on feedback from participant, Week 7, Month 9 and Month 9,Week 3|Acceptability: acceptability of PEth tests, Assessed using a series of multiple-choice feedback and open-ended questions on Post-Intervention Survey and 6-Month Post Intervention Survey and a series of prompts on final semi-structured interview focused on feedback from participant, Week 7, Month 9 and Month 9,Week 3
Secondary Outcome Measures: Neurocognitive symptoms mean score, Participants will answer 10 questions asking on a 4 point scale of "no or less" to "lot more" difficulty with different everyday cognitive responsibilities such as losing track of a current task, difficulty remembering appointments, etc. compared to 5 years ago, 4 weeks ago and 6 months ago. Total score range from 0-30. Higher scores will indicate higher cognitive dysfunction, and lower scores will indicate clearer cognitive function., Weeks 0, 7 and Month 9|Fall Risk, Participants will be asked about their history of falls and fractures to observe the interaction between cognitive decline and frequency of falls.The predicted probability of a fall is: Phat = 1/ (1 + exponent\^(-Linear Predictor), Weeks 0, 7 and Month 9|Readiness to Change mean score, A series of 6 questions asking participants on a Likert scale of 1= not at all to 10=extremely regarding their readiness, confidence and importance related to change behaviors about alcohol (3 questions) and medications (3 questions). Total score range 6-60. Higher scores will indicate a strong readiness to change., Weeks 0, 7 and Month 9|Alcohol Use assessed using PEth, Participants will complete 2 fingerstick blood spot phosphatidylethanol (PEth) tests on their own at home using items the study staff will provide in the mail. PEth testing uses blood to measure alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test with a score \<8 indicates alcohol use. Score: \<8 = Negative, 8-20 = Low to moderate alcohol use, 20-50 = Heavy alcohol use, 50\> = Very heavy alcohol use, Weeks 0 and Month 9|Alcohol Use Survey mean score, Participants will answer a series of questions on a 4-point scale of "Strongly Disagree" to "Strong Agree" related to their alcohol use. Each question is scored on a scale of 0 to 4, with a total possible score ranging from 0 to 40. Higher scores indicate a greater likelihood of alcohol-related problems or AUD., Weeks 0, 7 and Month 9|Cannabis Use, 1 question asking participants about cannabis use, Yes/No., Weeks 0, 7 and Month 9