A Phase 1 interventional study of Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique in Hiv, Alcohol Drinking and Fall, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Yale University · Phase 1, Interventional, and Prevention
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.
Pilot 2 will consist of a brief pharmacist-led intervention for patients with HIV who consumed alcohol in the past month, take 5 or more medications in addition to their antiretroviral therapy (ART) regimen, and one or more of their non ART medications is known to have neurocognitive effects (NCEs, not including antiseizure medications).
Prior to starting intervention: The study staff will recruit and obtain consent. Those who do not opt-out of the study will be contacted by phone and study staff will verify the individual currently consumes alcohol, administer the Alcohol Symptom Checklist, obtain verbal consent for the study, and verify their contact information. The Alcohol Symptom Checklist will be given as a screen during this first contact to determine level of alcohol use. Study staff will inform the participant about the self-administered blood spot test for phosphatidylethanol (PEth) and subsequently send a video with step-by-step instructions on how to perform these tests in a text message after the call. Finally, staff will schedule a brief call (estimated time of 15-20 minutes) with a VA clinical pharmacist assisting with recruitment approximately 3-5 days ahead to conduct a medication reconciliation. After enrollment is complete, a study staff member will request that a home test kit for PEth and the initial survey be sent to the participant from the West Haven Coordinating Center. Once completed, the participant will be asked to put the questionnaire in the self-addressed, stamped envelope and mail it back to the West Haven Coordinating Center. A separate envelope will be provided to send the biomarker samples directly to the analytic lab, processed at the United States Drug Testing Laboratories (USDTL) for rapid analysis.
After enrollment, participants will be contacted by a designated VA clinical pharmacist 1-2 days after the recruitment phone call to confirm a reconciliation of the participant's list of current medications. At this time, the clinical pharmacist will also schedule the intervention call that will take place four weeks ahead.
The intervention will be conducted by an additional group of VA clinical pharmacists specifically trained in IMB-MI procedures prior to the start of the study, following a training plan developed and delivered by expert advisors in the Risk Communication Resource Core of HARP, and trained to criterion standard. This training approach has been successfully used in our previous studies. The intervention will be digitally recorded to allow us to monitor fidelity. These recordings will be stored on our servers behind the VA firewall. Only those who are monitoring intervention fidelity will have access to these recordings.
4 weeks following the intervention call, the clinical pharmacist will check-in with the participant and inquire about their chosen goals and the progress they may or may not have been making, along with motivators and/or setbacks. The clinical pharmacists will remind the participant to complete the immediate post intervention survey (information, motivation, behavioral skills, importance and confidence, behavioral intentions \~5 minutes) once it arrives, and to return it in the enclosed postage paid. The participant is to mail the survey, along with completed monitoring forms from the previous weeks, back to the West Haven Coordinating Center in the self-addressed, stamped envelope provided.
6 months after the interview, participants will be sent a second PEth home test kit to measure changes in alcohol consumption with return envelope, along with a final 6-Month Post Intervention Survey measuring the items listed above, along with feedback questions related to feasibility of the study, clarity of instructions and provided information, PEth test, and open-ended questions for the participant to write in their own comments. We will also check VA EHR pharmacy data.
Finally, we will recontact a subset of participants for qualitative interviews that will elicit their feedback on the intervention. This information includes but is not limited to asking how difficult they found self-administering the PEth test, assessing whether their personalized risk estimate influenced their thinking on their alcohol or medication use, their views on cannabis use, their views on how clearly the clinical pharmacists were able to communicate risk information, how well they liked receiving the intervention from a clinical pharmacist, and the usefulness of the intervention provided to reduce alcohol use. These interviews will be targeted to occur within one week after the 30-day follow-up, but we will allow up to 1 month. We will conduct these interviews by telephone or Microsoft Teams. These conversations will be recorded.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 100 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Compared within Alcohol Drinking, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinical pharmacists will be trained by a team with expertise in behavioral and HIV clinical care, and participate in a 10-hour training course with coaching sessions offered over the course of the study to ensure effective and consistent performance. Pharmacists will be guided by a manual designed to provide and walk them through the necessary skills to perform the pilot intervention easily and effectively. The manual will provide background information, study goals, and describe the critical components of the IMB-MI model and the HARP pilot interventions. An easy to follow, step-by-step approach to performing the intervention will be included. The study protocol to be followed by the clinical pharmacists will be included in the manual along with additional motivational and troubleshooting strategies. Systematic feedback regarding intervention fidelity will be provided by the Evaluation Team.
Behavioral: Information Motivation Behavioral and Motivational Interviewing (IMB-MI) technique
Delivered 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).
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 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Week 7, Month 9 and Month 9,Week 3
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 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Weeks 0, 7 and Month 9
Cannabis Use
1 question asking participants about cannabis use, Yes/No.
Time frame: Weeks 0, 7 and Month 9
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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