Alcohol MisusePERCNCT07444359
The PEth Results Communication Study
A study testing PEth-Boosted Brief Intervention in people with Alcohol Misuse and Alcohol Biomarkers, run by University of California, San Francisco at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Misuse, Alcohol Biomarkers
- What is being tested?
- PEth-Boosted Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUganda
- Study dates
- 31 Aug 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Mbarara Univeristy of Science and Technology
Mbarara, 99999
Winnie R Muyindike, MBChB, MMED, +256772521619, Wmuyindike@gmail.com
Winnie R Muyindike, MBChB, MMED
About this study
Official title: The Phosphatidylethanol (PEth) Results Communication (PERC) Study
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.
Read the 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.
- Conditions
- Alcohol Misuse, Alcohol Biomarkers
- Being tested
- PEth-Boosted Brief Intervention
- Keywords
- Brief intervention (BI), Alcohol misuse, Alcohol counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEth-Boosted Brief InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PEth Boosted BI | Experimental | Participants in the PEth-Boosted BI arm will receive alcohol counseling (brief intervention, or BI) from a trained counselor who will be trained in the Uganda Ministry of Health's standard BI plus communication of PEth test results. Receives: Behavioral: PEth-Boosted Brief Intervention |
| Standard BI | No intervention | Participants in the Standard BI arm will receive alcohol counseling (brief intervention, or BI) from a trained counselor who will be trained in the Uganda Ministry of Health's standard BI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Changes in readiness for long-term alcohol reduction
We will explore changes (from baseline to follow-up) in readiness for behavior change using the Contemplation Ladder, a single-item scale with an overall score ranging from 0-10. Higher scores indicate greater readiness to change.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start31 Aug 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Judith A Hahn, PhD, MA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444359
- Sponsor's protocol ID
- 24-41429
- Other IDs
- R34AA031652
- Acronym
- PERC
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified data from the PERC study randomized controlled trial (RCT) described in Aim 2 to promote transparency and enable other researchers to build upon our findings. The quantitative data from this RCT will be shared with the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) a data repository housed within the NIMH Data Archive (NDA). Data from 80 participants will consist of self-reported survey data (e.g., demographics, alcohol and drug use), alcohol biomarker results (phosphatidylethanol \[PEth\]) derived from dried blood spot (DBS) samples, and study-specific data including; HIV viral load and self-reported antiretroviral therapy (ART) adherence (single-item measure), health care worker-enacted substance use-related stigma and anticipated stigma, internalized substance use-related stigma, and internalized HIV stigma. Data will be stored in Stata format and made available in Excel for ease of access.
Publications
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.
PubMed 31036002
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phosphatidylethanol (PEth) Results Communication (PERC) Study
- ClinicalTrials.gov ID
- NCT07444359
- Acronym / sponsor ID
- PERC / 24-41429
- Conditions
- Alcohol Misuse, Alcohol Biomarkers
- Keywords
- Brief intervention (BI), Alcohol misuse, Alcohol counseling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEth Boosted BI | Experimental | Behavioral: PEth-Boosted Brief InterventionParticipants in the PEth-Boosted BI arm will receive alcohol counseling (brief intervention, or BI) from a trained counselor who will be trained in the Uganda Ministry of Health's standard BI plus communication of PEth test results. |
| Standard BI | No intervention | –Participants in the Standard BI arm will receive alcohol counseling (brief intervention, or BI) from a trained counselor who will be trained in the Uganda Ministry of Health's standard BI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEth-Boosted Brief InterventionParticipants 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. | Behavioural | PEth Boosted BI |
Primary outcome
Acceptability of PEth-Boosted BI
Time frame: 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.
3 secondary outcomes
Changes in readiness for long-term alcohol reduction
Time frame: 3 months
Self-reported alcohol use and PEth
Time frame: 3 months
Alcohol-related stigma
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 31036002Haroz 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.
- Individual participant dataSharing planned: Yes. We will share de-identified data from the PERC study randomized controlled trial (RCT) described in Aim 2 to promote transparency and enable other researchers to build upon our findings. The quantitative data from this RCT will be shared with the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) a data repository housed within the NIMH Data Archive (NDA). Data from 80 participants will consist of self-reported survey data (e.g., demographics, alcohol and drug use), alcohol biomarker results (phosphatidylethanol [PEth]) derived from dried blood spot (DBS) samples, and study-specific data including; HIV viral load and self-reported antiretroviral therapy (ART) adherence (single-item measure), health care worker-enacted substance use-related stigma and anticipated stigma, internalized substance use-related stigma, and internalized HIV stigma. Data will be stored in Stata format and made available in Excel for ease of access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Judith A Hahn, PhD, MA principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEth-Boosted Brief Intervention in people with Alcohol Misuse and Alcohol Biomarkers, run by University of California, San Francisco at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nneka I Emenyonu, DrPH, MPH (415-476-5815, Nneka.Emenyonu@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of PEth-Boosted BI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07444359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.