Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-01-01 @ 3:19 AM
Study NCT ID:
NCT05560932
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amy.justice2@va.gov', 'phone': '203-932-5711', 'title': 'Amy C Justice, MD, PhD', 'phoneExt': '3541', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care).", 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General disorders and administration site conditions - Other, specify', 'notes': 'Patient left study temporarily for health reasons prior to intervention activities, then returned to participate.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Enrollment to Assess Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline', 'description': 'Number of participants that enrolled and provided informed consent', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '50 participants were enrolled. 12 did not complete any study activities.'}, {'type': 'PRIMARY', 'title': 'Completion to Assess Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study completion (Post-intervention Day 30)', 'description': 'Number of participants that completed the full pilot intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Qualitative Interviews to Assess Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study completion (within one to four weeks after Post-intervention Day 30)', 'description': 'Number of participants that successfully completed the qualitative interviews', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'classes': [{'title': 'Symptoms with improvement from baseline to post intervention Day 1.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Symptoms with improvement from baseline to post-intervention Day 30.', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, post-intervention Day 1, Post-intervention Day 30', 'description': "The HIV Symptoms Index is a 20-item, self-reported measure that assesses presence and perceived distress linked to symptoms associated with HIV or HIV treatment. There are 5 possible responses: 0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot, for each HIV symptom. Presented here is the number of bothersome symptoms with improvement on post-intervention Day 1 and post-intervention Day 30.", 'unitOfMeasure': 'symptoms', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Completed Both PEth Tests to Assess Acceptability.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and Post-intervention Day 30', 'description': 'Change in alcohol levels assessed measuring PEth levels in the blood. PEth testing uses blood to measure alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test indicates alcohol use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants Readiness to Change Prescribed Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'classes': [{'title': 'Readiness at baseline', 'categories': [{'measurements': [{'value': '6.9', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Readiness immediately post intervention (day 1)', 'categories': [{'measurements': [{'value': '7.7', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Readiness Post-intervention Day 30', 'categories': [{'measurements': [{'value': '7.1', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Importance at baseline', 'categories': [{'measurements': [{'value': '7.7', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Importance immediately post intervention (day 1)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Importance Post-intervention Day 30', 'categories': [{'measurements': [{'value': '7.0', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Confidence at baseline', 'categories': [{'measurements': [{'value': '6.9', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Confidence immediately post intervention (day 1)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Confidence Post-intervention Day 30', 'categories': [{'measurements': [{'value': '7.7', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, immediately post intervention (day 1) and Post-intervention Day 30', 'description': 'The mean score of participants responses by self report. Participants were asked "If your provider felt it was a good idea, how ready are you to decrease your medications?", "If your provider felt it was a good idea, how important is it for you to decrease your medications?", and "If your provider felt it was a good idea, how confident are you that you can decrease your medications?" Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participants Readiness to Change Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'classes': [{'title': 'Readiness at baseline', 'categories': [{'measurements': [{'value': '6.4', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Readiness immediately post intervention (day 1)', 'categories': [{'measurements': [{'value': '7.8', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Readiness Post-intervention Day 30', 'categories': [{'measurements': [{'value': '7.0', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Importance at baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Importance immediately post intervention (day 1)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Importance Post-intervention Day 30', 'categories': [{'measurements': [{'value': '6.83', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Confidence at baseline', 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Confidence immediately post intervention (day 1)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Confidence Post-intervention Day 30', 'categories': [{'measurements': [{'value': '8.7', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, immediately post intervention (day 1) and Post-intervention Day 30', 'description': 'The mean score of participants responses by self report. Participants were asked "If your provider felt it was a good idea, how ready are you to decrease your alcohol use?", "If your provider felt it was a good idea, how important is it for you to decrease your alcohol use?", and "If your provider felt it was a good idea, how confident are you that you can decrease your alcohol use?" Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Medication Use to Assess Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': 'Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol'}], 'classes': [{'title': 'Felt comfortable with the way medication information was presented', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Understood the information given', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Found the information helpful', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Felt the amount of information was adequate', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'felt the information that they received was clear', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-intervention Day 30', 'description': 'The number of respondents who reported they (1) felt comfortable with the way medication information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Information Regarding PEth to Assess Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': 'Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol'}], 'classes': [{'title': 'Felt comfortable with the way PEth information was presented', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Understood the information given', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Found the information helpful', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Felt the amount of information was adequate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Felt the information that they received was clear', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-intervention Day 30', 'description': 'The number of respondents who reported that they (1) felt comfortable with the way PEth information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'General Feedback to Assess Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Medications and Alcohol Use', 'description': 'Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol'}], 'classes': [{'title': 'Felt they learned new things about their health risk from alcohol', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Learned new things about their health risk from polypharmacy', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Learned how medications and alcohol can act together', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Felt that having a pharmacist to talk with was helpful', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-intervention Day 30', 'description': 'The number of respondents who (1) felt they learned new things about their health risk from alcohol, (2) learned new things about their health risk from polypharmacy, (3) learned how medications and alcohol can act together, and (4) felt that having a pharmacist to talk with was helpful. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'received intervention', 'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'Intervention Only', 'achievements': [{'comment': 'completed intervention but did not complete post-intervention assessments', 'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'completed study per protocol', 'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '50 enrolled, 12 did not complete any study activities, 38 started and received intervention'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV Medications and Alcohol Use', 'description': "Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol\n\nIMB-motivational interviewing (MI) techniques (IMB-MI): The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care)."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '8.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'High School Graduate', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Some College', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'College Graduate', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-18', 'size': 232692, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-12T11:47', 'hasProtocol': True}, {'date': '2025-05-14', 'size': 169054, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-14T12:30', 'hasProtocol': False}, {'date': '2023-02-10', 'size': 188210, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-12T11:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2022-09-26', 'resultsFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-17', 'studyFirstPostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment to Assess Feasibility', 'timeFrame': 'baseline', 'description': 'Number of participants that enrolled and provided informed consent'}, {'measure': 'Completion to Assess Feasibility', 'timeFrame': 'Study completion (Post-intervention Day 30)', 'description': 'Number of participants that completed the full pilot intervention'}, {'measure': 'Qualitative Interviews to Assess Feasibility', 'timeFrame': 'Study completion (within one to four weeks after Post-intervention Day 30)', 'description': 'Number of participants that successfully completed the qualitative interviews'}, {'measure': 'Change in Bothersome Symptoms From Baseline Using the HIV Symptoms Index', 'timeFrame': 'baseline, post-intervention Day 1, Post-intervention Day 30', 'description': "The HIV Symptoms Index is a 20-item, self-reported measure that assesses presence and perceived distress linked to symptoms associated with HIV or HIV treatment. There are 5 possible responses: 0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot, for each HIV symptom. Presented here is the number of bothersome symptoms with improvement on post-intervention Day 1 and post-intervention Day 30."}, {'measure': 'Number of Participants That Completed Both PEth Tests to Assess Acceptability.', 'timeFrame': 'baseline and Post-intervention Day 30', 'description': 'Change in alcohol levels assessed measuring PEth levels in the blood. PEth testing uses blood to measure alcohol use by detecting direct alcohol biomarkers in the bloodstream. A positive test indicates alcohol use.'}, {'measure': 'Participants Readiness to Change Prescribed Medications', 'timeFrame': 'baseline, immediately post intervention (day 1) and Post-intervention Day 30', 'description': 'The mean score of participants responses by self report. Participants were asked "If your provider felt it was a good idea, how ready are you to decrease your medications?", "If your provider felt it was a good idea, how important is it for you to decrease your medications?", and "If your provider felt it was a good idea, how confident are you that you can decrease your medications?" Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes.'}, {'measure': 'Participants Readiness to Change Alcohol Use', 'timeFrame': 'baseline, immediately post intervention (day 1) and Post-intervention Day 30', 'description': 'The mean score of participants responses by self report. Participants were asked "If your provider felt it was a good idea, how ready are you to decrease your alcohol use?", "If your provider felt it was a good idea, how important is it for you to decrease your alcohol use?", and "If your provider felt it was a good idea, how confident are you that you can decrease your alcohol use?" Each question is scored on a 1-10 scale (1=not at all ready, 10=extremely ready). Total score range for each question is 1-10 with higher scores indicating better outcomes.'}, {'measure': 'Medication Use to Assess Acceptability', 'timeFrame': 'Post-intervention Day 30', 'description': 'The number of respondents who reported they (1) felt comfortable with the way medication information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.'}, {'measure': 'Information Regarding PEth to Assess Acceptability', 'timeFrame': 'Post-intervention Day 30', 'description': 'The number of respondents who reported that they (1) felt comfortable with the way PEth information was presented, (2) understood the information given, (3) found the information helpful, (4) felt the amount of information was adequate, and (5) felt the information that they received was clear. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.'}, {'measure': 'General Feedback to Assess Acceptability', 'timeFrame': 'Post-intervention Day 30', 'description': 'The number of respondents who (1) felt they learned new things about their health risk from alcohol, (2) learned new things about their health risk from polypharmacy, (3) learned how medications and alcohol can act together, and (4) felt that having a pharmacist to talk with was helpful. Participants provided their responses to each question using a 5-point Likert scale (response options 1-5 with higher numbers indicating better acceptability). We will evaluate the number of participants who responded with a 4 or a 5.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV', 'Alcohol Use']}, 'descriptionModule': {'briefSummary': 'This pilot intervention will consist of a brief intervention for patients with HIV who take 5 or more medications and currently (within the past month) consume alcohol. The focus of this pilot will be on bothersome symptoms and the impact of alcohol use and medications on these symptoms. The rationale is that any alcohol use may interact with medications in serious ways leading to adverse outcomes, including bothersome symptoms.', 'detailedDescription': 'Additional outcomes were added at results entry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants in both Veterans Aging Cohort Study (VACS) and Medications, Alcohol, and Substance use in HIV (MASH) studies\n* prescribed 5 or more medications AND who either have a positive PEth value (8+) or a self-reported AUDIT-C value consistent with current alcohol use (score \\>0)\n\nExclusion Criteria:\n\n* Alcohol use disorder (AUD) diagnosis in the past 12 months or who test positive for AUD on the Alcohol Symptom Checklist for moderate or severe AUD (score of 4 or more)'}, 'identificationModule': {'nctId': 'NCT05560932', 'briefTitle': 'HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1', 'orgStudyIdInfo': {'id': 'Justice 090622'}, 'secondaryIdInfos': [{'id': 'P01AA029545-03', 'link': 'https://reporter.nih.gov/quickSearch/P01AA029545-03', 'type': 'NIH'}, {'id': 'P01 AA029545-03 sub 9238', 'type': 'OTHER_GRANT', 'domain': 'Sub Award P01 AA029545-03'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV Medications and Alcohol Use', 'description': 'Participants with HIV who take 5 or more medications and currently (within the past month) consume alcohol', 'interventionNames': ['Behavioral: IMB-motivational interviewing (MI) techniques (IMB-MI)']}], 'interventions': [{'name': 'IMB-motivational interviewing (MI) techniques (IMB-MI)', 'type': 'BEHAVIORAL', 'description': "The clinical pharmacist will employ MI in informational, participant-centered discussions in which the clinical pharmacist and participant collaboratively discuss the harms of drinking and polypharmacy (specifically alcohol interactive medications), symptoms associated with alcohol and specific medications, and how to mitigate these harms. Motivational elements include messages highlighting the participant's personal risk of bothersome symptoms from their use of alcohol and level of polypharmacy, attitude change elements to improve attitudes toward the intended behavior change, social normative support for the intended behavior change including identification of people who can support the participant in this process, and a menu of options for referrals for skill building (e.g. Social Work, meeting with the clinical pharmacist at their clinic, follow-up with the HIV clinician, alcohol-reduction programs, based on what is locally available as part of VA-based care).", 'armGroupLabels': ['HIV Medications and Alcohol Use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'West Haven CT Veterans Administration', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Amy C Justice, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will not be shared by placing it in a data repository, but will be shared with those who submit a reasonable request .'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}