The PEth Results Communication Study (PERC)

April 29, 2026 updated by: University of California, San Francisco

The Phosphatidylethanol (PEth) Results Communication (PERC) Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Primary 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).

Participants 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).

This 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Uganda
      • Mbarara, Uganda, 99999
        • Mbarara Univeristy of Science and Technology
        • Contact:
        • Principal Investigator:
          • Winnie R Muyindike, MBChB, MMED

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and older;
  • Resident in the study catchment area (<60 km or <2 hours travel);
  • Fluent in Runyankole or English;
  • Ability to give informed consent;
  • Unhealthy alcohol use (AUDIT-C ≥3 for women, ≥4 for men, OR PEth≥20); ng/mL at a previous study visit or PERC screening);
  • Having participated in a previous study, except for TRAC and PERC studies.

Exclusion Criteria:

  • Having already participated in Aim 1 of this study;
  • Having participated in the TRAC Study;
  • Not fluent in English or Runyankole;
  • Gross inebriation, cognitive impairment, or inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PEth Boosted BI
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.
Behavioral: PEth-Boosted Brief Intervention
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.
No Intervention: Standard BI
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of PEth-Boosted BI
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in readiness for long-term alcohol reduction
Time Frame: 3 months
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.
3 months
Self-reported alcohol use and PEth
Time Frame: 3 months
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.
3 months
Alcohol-related stigma
Time Frame: 3 months
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.
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of PEth-Boosted BI
Time Frame: 3 months
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.
3 months
Appropriateness of PEth-Boosted BI
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Judith A Hahn, PhD, MA, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-41429
  • R34AA031652 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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