Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:46 PM
Study NCT ID:
NCT07444359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PEth Results Communication Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Feasibility of PEth-Boosted BI', 'timeFrame': '3 months', 'description': 'Feasibility of the PEth-Boosted BI will be assessed using the "Feasibility of Intervention Measure (FIM)", a 4-item scale with an overall score ranging from 1-5; higher scores indicate more feasibility.'}, {'measure': 'Appropriateness of PEth-Boosted BI', 'timeFrame': '3 months', 'description': 'Appropriateness of the PEth-Boosted BI will be assessed using the "Intervention Appropriateness Measure (IAM)", a 4-item scale with an overall score ranging from 1-5; higher scores indicate more appropriateness.'}], 'primaryOutcomes': [{'measure': 'Acceptability of PEth-Boosted BI', 'timeFrame': '3 months', 'description': 'Acceptability of the PEth-Boosted Brief Intervention will be assessed using the "Acceptability of Intervention Measure (AIM)", a 4-item scale with an overall score ranging from 1-5; higher scores indicate more acceptability.'}], 'secondaryOutcomes': [{'measure': 'Changes in readiness for long-term alcohol reduction', 'timeFrame': '3 months', 'description': 'We will explore changes (from baseline to follow-up) in readiness for behavior change using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) v8a, a 19-item scale with an overall score ranging from 19-95. Higher scores indicate greater readiness to change.'}, {'measure': 'Self-reported alcohol use and PEth', 'timeFrame': '3 months', 'description': 'We will assess changes in self-reported alcohol use using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), modified for the follow-up period of 3 months, alcohol-related problems, and biomarker-confirmed use via PEth results.'}, {'measure': 'Alcohol-related stigma', 'timeFrame': '3 months', 'description': 'Enacted, anticipated, and internalized stigma will be measured using the Substance Use Stigma Mechanism Scale (SU-SMS), modified to ask about alcohol use only. The "Enacted Stigma", "Anticipated Stigma", and "Internalized Stigma" sub-scales of the SU-SMS each consist of 6 items, with scores ranging from 1-5; higher scores indicate greater stigma.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brief intervention (BI)', 'Alcohol misuse', 'Alcohol counseling'], 'conditions': ['Alcohol Misuse', 'Alcohol Biomarkers', 'Brief Intervention', 'Alcohol Counseling']}, 'referencesModule': {'references': [{'pmid': '31036002', 'type': 'BACKGROUND', 'citation': 'Haroz EE, Bolton P, Nguyen AJ, Lee C, Bogdanov S, Bass J, Singh NS, Doty B, Murray L. Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC Health Serv Res. 2019 Apr 29;19(1):262. doi: 10.1186/s12913-019-4097-y.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial (RCT) to test whether adding PEth (a blood test that shows recent alcohol use) to a standard alcohol counseling session in clinic helps people with HIV reduce their drinking. A total of 80 participants will be enrolled with unhealthy alcohol use: 40 will receive the standard MOH brief alcohol counseling plus discussion of their PEth results and 40 will receive the standard Uganda Ministry of Health (MOH) brief alcohol counseling alone. After 3 months, the study will look at whether participants found the intervention acceptable, appropriate, and feasible. The study also explore changes in alcohol use, motivation to reduce drinking, and experiences of stigma.', 'detailedDescription': 'This randomized controlled trial (RCT) will evaluate the feasibility, acceptability, and appropriateness of incorporating phosphatidylethanol (PEth) biomarker testing into brief alcohol interventions (BI) for persons with HIV (PWH) and unhealthy alcohol use in Uganda. A total of 80 participants will be enrolled in the RCT and will be randomized in blocks of 8 to receive either: (1) a PEth-boosted BI, which integrates PEth test results into the Ministry of Health (MOH) standard BI protocol, or (2) the standard MOH BI alone. Follow-up will occur over 3 months.\n\nPrimary outcomes include acceptability, appropriateness, and feasibility, assessed via validated and adapted survey tools. Secondary outcomes include changes in readiness to reduce alcohol use, self-reported alcohol use (AUDIT-C), PEth levels, alcohol-related problems, and stigma (internalized HIV stigma and alcohol-related stigma from healthcare providers).\n\nParticipants will complete a baseline and 3-month follow-up survey. Data will be collected via interviewer-administered surveys using REDCap in English or Runyankole (the local language in Mbarara, Uganda).\n\nThis trial will provide pilot data to inform the design of a larger effectiveness trial and identify strategies for integrating PEth testing into routine HIV care to improve alcohol-related outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older;\n* Resident in the study catchment area (\\<60 km or \\<2 hours travel);\n* Fluent in Runyankole or English;\n* Ability to give informed consent;\n* Unhealthy alcohol use (AUDIT-C ≥3 for women, ≥4 for men, OR PEth≥20); ng/mL at a previous study visit or PERC screening);\n* Having participated in a previous study, except for TRAC and PERC studies.\n\nExclusion Criteria:\n\n* Having already participated in Aim 1 of this study;\n* Having participated in the TRAC Study;\n* Not fluent in English or Runyankole;\n* Gross inebriation, cognitive impairment, or inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07444359', 'acronym': 'PERC', 'briefTitle': 'The PEth Results Communication Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Phosphatidylethanol (PEth) Results Communication (PERC) Study', 'orgStudyIdInfo': {'id': '24-41429'}, 'secondaryIdInfos': [{'id': 'R34AA031652', 'link': 'https://reporter.nih.gov/quickSearch/R34AA031652', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEth Boosted BI', 'description': "Participants in the PEth-Boosted BI arm will receive alcohol counseling (brief intervention, or BI) from a trained counselor who will be trained in the Uganda Ministry of Health's standard BI plus communication of PEth test results.", 'interventionNames': ['Behavioral: PEth-Boosted Brief Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard BI', 'description': "Participants in the Standard BI arm will receive alcohol counseling (brief intervention, or BI) from a trained counselor who will be trained in the Uganda Ministry of Health's standard BI."}], 'interventions': [{'name': 'PEth-Boosted Brief Intervention', 'type': 'BEHAVIORAL', 'description': 'Participants in the intervention arm of the study will receive an alcohol BI delivered by study staff boosted by PEth results communication per study-developed protocols.', 'armGroupLabels': ['PEth Boosted BI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99999', 'city': 'Mbarara', 'country': 'Uganda', 'contacts': [{'name': 'Winnie R Muyindike, MBChB, MMED', 'role': 'CONTACT', 'email': 'Wmuyindike@gmail.com', 'phone': '+256772521619'}, {'name': 'Winnie R Muyindike, MBChB, MMED', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mbarara Univeristy of Science and Technology', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'centralContacts': [{'name': 'Nneka I Emenyonu, DrPH, MPH', 'role': 'CONTACT', 'email': 'Nneka.Emenyonu@ucsf.edu', 'phone': '415-476-5815'}, {'name': 'Robin Fatch, MPH', 'role': 'CONTACT', 'email': 'Robin.Fatch@ucsf.edu', 'phone': '415-476-5815'}], 'overallOfficials': [{'name': 'Judith A Hahn, PhD, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov/niaaa', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data for this RCT will be made available according to the guidelines of the NIAAADA. All scientific data generated from this project will be made available no later than the time of publication or the end of the funding period (May 30, 2027), whichever comes first. The duration of preservation and sharing of the data will be for the lifetime of the NIAAADA.', 'ipdSharing': 'YES', 'description': 'We will share de-identified data from the PERC study randomized controlled trial (RCT) described in Aim 2 to promote transparency and enable other researchers to build upon our findings. The quantitative data from this RCT will be shared with the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) a data repository housed within the NIMH Data Archive (NDA). Data from 80 participants will consist of self-reported survey data (e.g., demographics, alcohol and drug use), alcohol biomarker results (phosphatidylethanol \\[PEth\\]) derived from dried blood spot (DBS) samples, and study-specific data including; HIV viral load and self-reported antiretroviral therapy (ART) adherence (single-item measure), health care worker-enacted substance use-related stigma and anticipated stigma, internalized substance use-related stigma, and internalized HIV stigma. Data will be stored in Stata format and made available in Excel for ease of access.', 'accessCriteria': 'The PERC Study data will be shared in a way that minimizes barriers to access and use and in accordance with NIAAADA guidelines. There are no anticipated factors or limitations that will affect the access, distribution or reuse of the scientific data. Data will be accessible upon approval according to the guidelines for data use of the NIAAADA. Study data will be findable and identifiable by the NDA search functions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}