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.

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.

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.

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.

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.

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.