The PEth Results Communication Study

Официальное название

The Phosphatidylethanol (PEth) Results Communication (PERC) Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое PEth-Boosted Brief Intervention
  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.

Первичные конечные точки

• Acceptability of PEth-Boosted BI [Срок оценки: 3 months]

Вторичные конечные точки (3)

• Changes in readiness for long-term alcohol reduction [Срок оценки: 3 months]
• Self-reported alcohol use and PEth [Срок оценки: 3 months]
• Alcohol-related stigma [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Uganda · 1 центр

• Mbarara Univeristy of Science and Technology — Mbarara

Публикации

• 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

Идентификаторы

NCT: NCT07444359 · 24-41429 · R34AA031652

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗