The PERC Study
The International URBAN ARCH Center is excited to feature the The Phosphatidylethanol (PEth) Results Communication (PERC) study (R34AA031652). The PERC study was funded in June 2024 for a total of 3 years and is led by Dr. Judy Hahn, Professor of Medicine at the University of California San Francisco (UCSF) and project lead for the International URBAN ARCH Center TRAC study. This affiliated, NIAAA-funded study will pilot the addition of phosphtidylethanol (PEth) testing and results dissemination to a standard brief intervention (BI) for unhealthy alcohol use in HIV care in Uganda. PEth is a blood biomarker of prior month alcohol consumption with the potential to be an important tool in clinical settings and substance use treatment, particularly for people with HIV (PWH). The brief intervention is being rolled out by the Uganda Ministry of Health in HIV care. The research will be conducted via focus group discussions with PWH, HIV clinic staff, a community advisory board, meetings with MOH members, and field testing and pilot testing the protocols. The study will determine the acceptability, appropriateness, and feasibility of adding PEth results communication to brief alcohol interventions, and decide if a large scale trial is warranted.
In Aim 1 of the study, the team will develop approaches for adding PEth results communication to alcohol BIs. To accomplish this aim, the study team will elicit input via a series of focus group discussions (FGDs) including theater testing and role playing, with several groups of stakeholders (patients, clinic staff, community, and government), and conduct field testing and interviews with PWH who engage in unhealthy alcohol use.
In Aim 2 of the study, the team will explore the acceptability, appropriateness, and feasibility of adding PEth results communication to an alcohol BI in a pilot randomized controlled trial (n=80), with PWH who engage in unhealthy alcohol use. Participants will be randomized to receive either PEth-boosted BI or the standard BI that is being rolled out in HIV care in Uganda. The primary measures will be acceptability, appropriateness, and feasibility of the intervention, measured quantitatively and qualitatively. The study team will explore changes in readiness for alcohol reduction and changes in PEth at three months, by study arm. These results will be shared in FGDs with the stakeholders from Aim 1 to determine future directions, including moving forward will a larger trial.
The PERC study is the latest led by Dr. Judy Hahn in a nearly 20-year history of studies focused on biomarkers of alcohol use, including the BAHR study (R01AA029962), which was previously featured in URBAN ARCH News in December 2023. The PERC study leverages an ongoing partnership with Mbarara University of Science and Technology (MUST) and will utilize the expertise of co-investigators Dr. Winnie Muyindike, Senior Lecturer and Director of the ISS Clinic in the Mbarara Regional Referral Hospital at MUST, and Dr. Esther Atukunda, Senior Lecturer at MUST. Dr. Amanda Miller, Assistant Professor at San Diego State University, and Dr. Sarah Woolf-King, Associate Professor at Syracuse University, will also serve as co-investigators for the study. Dr. Nneka Emenyonu will serve as the Project Director for the study.
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Last fall, Dr. Hahn also received funding from the UCSF AIDS Research Institute for the PEth Capacity-Building study, a sister study to the PERC study. While PEth testing is currently conducted using liquid chromatography with tandem mass spectrometry (LC-MS/MS), a new enzyme-linked immunosorbent assay (ELISA) PEth test has been developed, which may help to increase the availability of PEth testing. This study aims to build capacity for PEth ELISA testing in Uganda, and assess participant perceptions and experiences of receiving PEth ELISA results in the research setting, and the impact on subsequent alcohol use and other behaviors, such as ART adherence. As part of this work, Yona Mbalibulha, the laboratory manager for the studies, recently traveled to the US to train on the PEth ELISA testing protocol developed by Echelon Biosciences, and adapt it for use at MUST. Read more about Yona in this issue’s spotlight interview.
Currently, the team is preparing to begin recruitment for Aim 1 of the study. Dr. Emenyonu, Dr. Miller, and Dr. Hahn traveled to Mbarara in November for study training with the team. After a week of intense trainings, the team was able to celebrate at a launch party with collaborators and other research teams. Congratulations to the PERC team on the launch of the study, and best of luck as you begin recruitment!
