Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07444359
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.
Detailed Description:
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.
Study:
NCT07444359
Study Brief:
Protocol Section:
NCT07444359