HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HIV+
have visited a local VA site in within the past year
had an AUDIT-C indicating current alcohol use
taking 5 or more non-ART medications, including an NCAM (i.e., benzodiazepines, opioids, muscle relaxants, sleeping medication, and selective serotonin reuptake inhibitors)
Disqualifiers
Inpatient individuals
Patients with an Alcohol Use Disorder (AUD) diagnosis in the past 12 months
Patients who test positive on the Alcohol Symptom Checklist for moderate or severe AUD during the screening process
Trial design
Design model
Single group
Treatments tested in this trial
Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique
BehavioralDelivered by a clinical pharmacist who will employ IMB-MI in informational, participant-centered discussions in which the clinical pharmacist and the participant collaboratively discuss the harms of alcohol use (with or without concurrent use of cannabis) and polypharmacy (specifically neurocognitively active medications), the relationship of these exposures to fall risk and NCEs, and how to mitigate these harms. Together pharmacist and participant will develop a plan for change in alcohol and polypharmacy use, self-monitoring, medications of concern, symptoms, and any additional resources needed. The goal of the intervention being to help patients stop or decrease alcohol use and stop medications in situations where it is safe to do so and agreed upon by the primary provider (but substitutions will be made if necessary).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Pharmacist lead interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week -2 to Week 02
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
Time frame
Week 3 and week 73
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.
Time frame
up to Month 94
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
Time frame
Week 7, Month 9 and Month 9,Week 3Secondary outcomes
1
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.
Time frame
Weeks 0, 7 and Month 92
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)
Time frame
Weeks 0, 7 and Month 93
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.
Time frame
Weeks 0, 7 and Month 94
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
Time frame
Weeks 0 and Month 9Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov