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.