Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513819
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
HIV and Alcohol Research Center Focused on Polypharmacy HARP Pilot 2 2nd HARP Pilot Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HIV and Alcohol Research Center Focused on Polypharmacy HARP Pilot 2 2nd HARP Pilot Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HARP
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 participants 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 andor 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
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 participants 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None