The PEth Results Communication Study

NCT07444359 | Not Yet Recruiting

• 2 other identifiers: 24-41429R34AA031652
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Misuse; Alcohol Biomarkers

Keywords

Brief intervention (BI); Alcohol misuse; Alcohol counseling

Outcome Measures

Primary Outcomes (1)

• Acceptability of PEth-Boosted BI

  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 Outcomes (3)

• Changes in readiness for long-term alcohol reduction

  3 months

• Self-reported alcohol use and PEth

  3 months

• Alcohol-related stigma

  3 months

Other Outcomes (2)

• Feasibility of PEth-Boosted BI

  3 months

• Appropriateness of PEth-Boosted BI

  3 months

Study Arms (2)

PEth Boosted BI

EXPERIMENTAL

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

Standard BI

NO INTERVENTION

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

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.

PEth Boosted BI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Mbarara Univeristy of Science and Technology

Mbarara, 99999, Uganda

Location

Related Publications (1)

• 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.

  PMID: 31036002 BACKGROUND

Study Officials

• Judith A Hahn, PhD, MA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nneka I Emenyonu, DrPH, MPH

CONTACT

415-476-5815; Nneka.Emenyonu@ucsf.edu

Robin Fatch, MPH

CONTACT

415-476-5815; Robin.Fatch@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: March 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

UG (1)