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NCT Number: NCT07444359

The PEth Results Communication 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.

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Key information

Conditions

Alcohol Misuse Alcohol Biomarkers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mbarara Univeristy of Science and Technology

Mbarara, 99999, Uganda

Location contact

Winnie R Muyindike, MBChB, MMED

CONTACT

[email protected]

+256772521619

Winnie R Muyindike, MBChB, MMED

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEth-Boosted Brief Intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nneka I Emenyonu, DrPH, MPH

CONTACT

[email protected]

415-476-5815

Robin Fatch, MPH

CONTACT

[email protected]

415-476-5815

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

The Phosphatidylethanol (PEth) Results Communication (PERC) Study

Acronym: PERC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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