The PEth Results Communication Study (NCT07444359) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The PEth Results Communication Study
Uganda80 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.