Alcohol Biomarkers, Alcohol Misuse
Conditions
Keywords
Brief intervention (BI), Alcohol misuse, Alcohol counseling
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.
Interventions
BEHAVIORALPEth-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.
Sponsors
University of California, San Francisco
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of PEth-Boosted BI | 3 months | Acceptability of the PEth-Boosted Brief Intervention will be assessed using the "Acceptability of Intervention Measure (AIM)", a 4-item scale with an overall score ranging from 1-5; higher scores indicate more acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in readiness for long-term alcohol reduction | 3 months | We will explore changes (from baseline to follow-up) in readiness for behavior change using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) v8a, a 19-item scale with an overall score ranging from 19-95. Higher scores indicate greater readiness to change. |
| Self-reported alcohol use and PEth | 3 months | We will assess changes in self-reported alcohol use using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), modified for the follow-up period of 3 months, alcohol-related problems, and biomarker-confirmed use via PEth results. |
| Alcohol-related stigma | 3 months | Enacted, anticipated, and internalized stigma will be measured using the Substance Use Stigma Mechanism Scale (SU-SMS), modified to ask about alcohol use only. The "Enacted Stigma", "Anticipated Stigma", and "Internalized Stigma" sub-scales of the SU-SMS each consist of 6 items, with scores ranging from 1-5; higher scores indicate greater stigma. |
Countries
Uganda
Contacts
CONTACTNneka I Emenyonu, DrPH, MPH
CONTACTRobin Fatch, MPH
PRINCIPAL_INVESTIGATORJudith A Hahn, PhD, MA
University of California, San Francisco
Outcome results
None listed