The PEth Results Communication Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PEth-Boosted Brief Intervention
BehavioralParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: PEth Boosted BIExperimental treatment 1 intervention
Group B: Standard BINo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Acceptability of PEth-Boosted BI
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.
Time frame
3 monthsSecondary outcomes
1
Changes in readiness for long-term alcohol reduction
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.
Time frame
3 months2
Self-reported alcohol use and PEth
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.
Time frame
3 months3
Alcohol-related stigma
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.
Time frame
3 monthsOther outcomes
1
Feasibility of PEth-Boosted BI
Feasibility of the PEth-Boosted BI will be assessed using the "Feasibility of Intervention Measure (FIM)", a 4-item scale with an overall score ranging from 1-5; higher scores indicate more feasibility.
Time frame
3 months2
Appropriateness of PEth-Boosted BI
Appropriateness of the PEth-Boosted BI will be assessed using the "Intervention Appropriateness Measure (IAM)", a 4-item scale with an overall score ranging from 1-5; higher scores indicate more appropriateness.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: