Clinical trial NCT06513819: HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
Official title: HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hiv
Alcohol Drinking
Fall
Cannabis Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Veterans Aging Cohort Study (VACS)-HIV database of 30 thousand veterans will be utilized to recruit eligible participants.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility: Ability to meet enrollment target of 100 participants
timeFrame: Week -2 to Week 0
measure: Feasibility: Ability to deliver the complete intervention
timeFrame: Week 3 and week 7
measure: Feasibility:Percentage of Completion of Study Items
timeFrame: up to Month 9
measure: Acceptability: comfort, comprehensibility/helpfulness of content
timeFrame: Week 7, Month 9 and Month 9,Week 3
measure: Acceptability: acceptability of PEth tests
timeFrame: Week 7, Month 9 and Month 9,Week 3
Secondary outcomes:
measure: Neurocognitive symptoms mean score
timeFrame: Weeks 0, 7 and Month 9
measure: Fall Risk
timeFrame: Weeks 0, 7 and Month 9
measure: Readiness to Change mean score
timeFrame: Weeks 0, 7 and Month 9
measure: Alcohol Use assessed using PEth
timeFrame: Weeks 0 and Month 9
measure: Alcohol Use Survey mean score
timeFrame: Weeks 0, 7 and Month 9
measure: Cannabis Use
timeFrame: Weeks 0, 7 and Month 9
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Amy C Justice, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: