Alcohol Use DisorderPRACTNCT04535011

PRACT to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department BIs in Tanzania

A study testing PPKAY (brief intervention), Standard Booster and Personalized Booster in people with Alcohol Use Disorder and Injury Traumatic, run by Duke University at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcohol Use Disorder, Injury Traumatic, Trauma
What is being tested?: PPKAY (brief intervention), Standard Booster and Personalized Booster
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 673 participants
Where: 1 siteTanzania
Study dates: 12 Oct 2020to 30 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 of age)
present seeking initial care at the KCMC ED for an acute (<24 hours) injury
not clinically intoxicated (i.e., have capacity to consent).
one or more of the following: 1) disclosed alcohol use prior to injury, 2) scored ≥8 on the AUDIT, 3) test positive (>0.0 g/dL) by alcohol breathalyzer.

Who cannot join

do not speak the native Swahili language
too ill or unable to communicate
prior enrollment in this study
decline informed consent.

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

Kilimanjaro Christian Medical Centre
Moshi, Kilimanjaro

Other trials in Tanzania

About this study

Official title: PRACT: A Pragmatic Randomized Adaptive Clinical Trial to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department Brief Interventions in Tanzania

Alcohol use is rapidly increasing in low- and middle-income countries, where it is inexpensive, readily available, poorly regulated, and there are few resources devoted to promoting safe alcohol use. A Brief Intervention based on a motivational interviewing framework has been shown to reduce alcohol use and alcohol-related harms. The investigators have translated and adapted a Brief Intervention for alcohol to the Tanzanian context and Swahili language called "Punguza Pombe Kwa Afya Yako (PPKAY)/ Reduce Alcohol for Your Health." This project will evaluate this intervention in injury patients presenting for care at the Kilimanjaro Christian Medical Center in Moshi, Tanzania. By using innovative adaptive clinical trial methods, the investigators will expedite the development of the most effective way to integrate this intervention into clinical care. By the end of this project, investigators will have identified the most effective brief intervention components and be able to characterize the intervention's effect overall. Additionally, investigators will standardize adaptive trial methods to revolutionize the science of clinical trials for behavioral sciences in low-resource settings.

Conditions: Alcohol Use Disorder, Injury Traumatic, Trauma
Being tested: PPKAY (brief intervention), Standard Booster, Personalized Booster
Medical subject headings: Alcoholism, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PPKAY (brief intervention)Behavioural
PPKAY is a nurse-administered, one-on-one, 15-minute brief intervention (BI) for alcohol use using FRAMES motivational interviewing techniques. The BI is a four-step discussion: 1) Raise the Subject of Alcohol, 2) Provide Feedback, 3) Enhance Motivation 4) Negotiate and Advice.
Standard BoosterBehavioural
After discharge from the hospital, a standard motivational text message will be sent to their cell phone twice monthly for the duration of the study. In a rotating fashion, one of four standard motivational texts translated into Swahili will be sent to their cell phones.
Personalized BoosterBehavioural
After discharge from the hospital, a personalized motivational text message will be sent to participant cell phones twice monthly for the duration of the study. In a rotating fashion, one of four personalized motivational texts will be sent to their cell phones. Personalized texts will be created with the content obtained from the motivational interview sessions. At each session, the research nurse conducting the intervention will record four messages based on the content of the session to be sent as the Personalized Booster.

Study groups in NCT04535011
Study group	Role	What they receive
Usual Care	No intervention	No prevention or educational information verbally or written coinciding with current usual care
PPKAY	Experimental	One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use Receives: Behavioral: PPKAY (brief intervention)
PPKAY with Standard Booster	Experimental	One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use. Weekly standard text booster until final follow-up (e.g., "Reducing your alcohol intake to less than 4 drinks per day reduces your risk of alcohol-related consequences") Receives: Behavioral: PPKAY (brief intervention); Behavioral: Standard Booster
PPKAY with Personalized Booster	Experimental	One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use Weekly personalized text booster until final follow-up (e.g., "Remember to reduce your alcohol less than 4 drinks to achieve your goal of… [being a better husband].") Receives: Behavioral: PPKAY (brief intervention); Behavioral: Personalized Booster

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Binge Drinking Days (Previous 4 Weeks)
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Secondary outcomes (5)

Frequency of Alcohol Use (Previous 2 Weeks)
Reported as the number of drinking days during the past two weeks.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Quantity of Alcohol Use (Previous 2 Weeks)
Reported as the number of drinks consumed during the past two weeks.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Alcohol-related Harms Measured by the Drinker Inventory of Consequences (DrInC)
The Drinker Inventory of Consequences (DrInC) is a fifty-item questionnaire with scores ranging from 0 to 150, where a higher number indicates a greater number of negative consequences.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
AUDIT (Alcohol Use Disorder Identification Test) Score
Alcohol use disorder as measured by AUDIT (alcohol use disorder identification test) score. AUDIT is a ten-item tool, with scores ranging from 0 to 40, where a higher score indicates higher risk alcohol use.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Depression as Measured by Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 consists of 9 simple questions evaluating core symptoms of depression over the past two weeks. Each item is rated on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater symptom severity.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 202030 May 2025

First posted1 Sep 2020
Study start12 Oct 2020
Primary completion30 May 2025
Study completion30 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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: Sequential
Model description: Study Phase 1: The investigators will evaluate whether PPKAY with personalized text booster or PPKAY with standard text booster will reduce the quantity or frequency of alcohol use, the number of binge drinking events or the number of alcohol-related consequences based on the Drinker Inventory of Consequences (DrInC) compared to usual care. Study Phase 2: The investigators will evaluate whether PPKAY alone is an inferior supplement to PPKAY plus standard or personalized text booster
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 673 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04535011
Sponsor's protocol ID: Pro00103724
Other IDs: R01AA027512
Acronym: PRACT
Status last verified: Oct 2026
First submitted: 27 Aug 2020
Last updated: 4 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Staton CA, Minja L, de Souza JVP, Gallis JA, Santos PCP, Buono M, Sakita F, Ngowi K, Boshe J, Phillips AJ, Vissoci JRN, Mmbaga BT. Effectiveness of a brief intervention and text-based booster in the emergency department to reduce harmful and hazardous alcohol use: A pragmatic randomized adaptive clinical trial in Moshi, Tanzania. PLoS Med. 2025 Oct 27;22(10):e1004548. doi: 10.1371/journal.pmed.1004548. eCollection 2025 Oct.
PubMed 41144564
Staton CA, Agnihotri D, Phillips AJ, Ngowi K, Huo L, Boshe J, Sakita F, Tupetz A, Suffoletto B, Mmbaga BT, Vissoci JRN. Development of culturally-appropriate text message booster content to follow a brief intervention focused on reducing alcohol related harms for injury patients in Moshi, Tanzania. PLOS Glob Public Health. 2024 Jul 25;4(7):e0002717. doi: 10.1371/journal.pgph.0002717. eCollection 2024.
PubMed 39052647
Staton CA, Zadey S, O'Leary P, Phillips A, Minja L, Swahn MH, Hirshon JM, Boshe J, Sakita F, Vissoci JRN, Mmbaga BT. PRACT: a pragmatic randomized adaptive clinical trial protocol to investigate a culturally adapted brief negotiational intervention for alcohol use in the emergency department in Tanzania. Trials. 2022 Feb 5;23(1):120. doi: 10.1186/s13063-022-06060-y.
PubMed 35123566

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PRACT: A Pragmatic Randomized Adaptive Clinical Trial to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department Brief Interventions in Tanzania
ClinicalTrials.gov ID: NCT04535011
Acronym / sponsor ID: PRACT / Pro00103724
Conditions: Alcohol Use Disorder, Injury Traumatic, Trauma
Study type: Interventional
Recruitment status: Completed
Enrolment: 673 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Kilimanjaro Christian Medical Centre, Tanzania, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 12 Oct 2020 (actual)
Primary completion: 30 May 2025 (actual)
Study completion: 30 May 2025 (actual)
First posted: 1 Sep 2020 (actual)
Results: Posted 4 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4
Model description: Study Phase 1: The investigators will evaluate whether PPKAY with personalized text booster or PPKAY with standard text booster will reduce the quantity or frequency of alcohol use, the number of binge drinking events or the number of alcohol-related consequences based on the Drinker Inventory of Consequences (DrInC) compared to usual care. Study Phase 2: The investigators will evaluate whether PPKAY alone is an inferior supplement to PPKAY plus standard or personalized text booster

Arm	Type	Receives
Usual Care	No intervention	–No prevention or educational information verbally or written coinciding with current usual care
PPKAY	Experimental	Behavioral: PPKAY (brief intervention)One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use
PPKAY with Standard Booster	Experimental	Behavioral: PPKAY (brief intervention), Behavioral: Standard BoosterOne-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use. Weekly standard text booster until final follow-up (e.g., "Reducing your alcohol intake to less than 4 drinks per day reduces your risk of alcohol-related consequences")
PPKAY with Personalized Booster	Experimental	Behavioral: PPKAY (brief intervention), Behavioral: Personalized BoosterOne-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use Weekly personalized text booster until final follow-up (e.g., "Remember to reduce your alcohol less than 4 drinks to achieve your goal of… [being a better husband].")

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

≥18 years of age)
present seeking initial care at the KCMC ED for an acute (<24 hours) injury
not clinically intoxicated (i.e., have capacity to consent).
one or more of the following: 1) disclosed alcohol use prior to injury, 2) scored ≥8 on the AUDIT, 3) test positive (>0.0 g/dL) by alcohol breathalyzer.

Key exclusion criteria (4 listed)

do not speak the native Swahili language
too ill or unable to communicate
prior enrollment in this study
decline 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
PPKAY (brief intervention)PPKAY is a nurse-administered, one-on-one, 15-minute brief intervention (BI) for alcohol use using FRAMES motivational interviewing techniques. The BI is a four-step discussion: 1) Raise the Subject of Alcohol, 2) Provide Feedback, 3) Enhance Motivation 4) Negotiate and Advice.	Behavioural	PPKAY, PPKAY with Personalized Booster, PPKAY with Standard Booster
Standard BoosterAfter discharge from the hospital, a standard motivational text message will be sent to their cell phone twice monthly for the duration of the study. In a rotating fashion, one of four standard motivational texts translated into Swahili will be sent to their cell phones.	Behavioural	PPKAY with Standard Booster
Personalized BoosterAfter discharge from the hospital, a personalized motivational text message will be sent to participant cell phones twice monthly for the duration of the study. In a rotating fashion, one of four personalized motivational texts will be sent to their cell phones. Personalized texts will be created with the content obtained from the motivational interview sessions. At each session, the research nurse conducting the intervention will record four messages based on the content of the session to be sent as the Personalized Booster.	Behavioural	PPKAY with Personalized Booster

Primary outcome

Number of Binge Drinking Days (Previous 4 Weeks)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

5 secondary outcomes

Frequency of Alcohol Use (Previous 2 Weeks)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Quantity of Alcohol Use (Previous 2 Weeks)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Alcohol-related Harms Measured by the Drinker Inventory of Consequences (DrInC)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
AUDIT (Alcohol Use Disorder Identification Test) Score
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Depression as Measured by Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Results and safety

Results posted to the registry on 4 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage I: Usual Care	171	129
Stage I: PPKAY With Standard Booster	203	131
Stage I: PPKAY With Personalized Booster	210	110
Stage II: PPKAY	0	0

Primary outcome: Number of Binge Drinking Days (Previous 4 Weeks)

Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months. Mean (Standard Deviation). Unit: days

Measure	Usual Care n = 163	PPKAY n = 88	PPKAY With Standard Booster n = 186	PPKAY With Personalized Booster n = 201
Baseline	3.7 (7.0)	4.3 (7.6)	4.2 (7.3)	4.1 (6.7)
3 months	0.9 (3.8)	1.2 (4.9)	0.6 (3.0)	0.3 (2.3)
6 months	1.3 (4.7)	0.5 (1.4)	0.7 (2.9)	0.4 (2.5)
9 months	1.5 (4.5)	0.6 (1.5)	0.8 (3.8)	0.3 (1.3)
12 months	1.6 (4.3)	0.8 (2.0)	1.1 (4.3)	0.3 (1.4)
24 months	2.5 (6.8)	–	0.7 (2.9)	0.2 (1.0)

Usual Care vs PPKAY vs PPKAY With Standard Booster vs PPKAY With Personalized Booster: Mean Difference (Final Values): -1.2 (95% CI -2.3 to -0.3), p = 0.002, Mixed Models Analysis

Population analysed: Participants with data collected at each timepoint. No PPK participants provided data at 24 months.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 171 (0%)	0 of 171 (0%)	5 of 171
PPKAY	0 of 89 (0%)	0 of 89 (0%)	1 of 89
PPKAY With Standard Booster	0 of 203 (0%)	0 of 203 (0%)	4 of 203
PPKAY With Personalized Booster	0 of 210 (0%)	0 of 210 (0%)	5 of 210

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41144564Staton CA, Minja L, de Souza JVP, Gallis JA, Santos PCP, Buono M, Sakita F, Ngowi K, Boshe J, Phillips AJ, Vissoci JRN, Mmbaga BT. Effectiveness of a brief intervention and text-based booster in the emergency department to reduce harmful and hazardous alcohol use: A pragmatic randomized adaptive clinical trial in Moshi, Tanzania. PLoS Med. 2025 Oct 27;22(10):e1004548. doi: 10.1371/journal.pmed.1004548. eCollection 2025 Oct.
Derived from this study: PubMed 39052647Staton CA, Agnihotri D, Phillips AJ, Ngowi K, Huo L, Boshe J, Sakita F, Tupetz A, Suffoletto B, Mmbaga BT, Vissoci JRN. Development of culturally-appropriate text message booster content to follow a brief intervention focused on reducing alcohol related harms for injury patients in Moshi, Tanzania. PLOS Glob Public Health. 2024 Jul 25;4(7):e0002717. doi: 10.1371/journal.pgph.0002717. eCollection 2024.
Derived from this study: PubMed 35123566Staton CA, Zadey S, O'Leary P, Phillips A, Minja L, Swahn MH, Hirshon JM, Boshe J, Sakita F, Vissoci JRN, Mmbaga BT. PRACT: a pragmatic randomized adaptive clinical trial protocol to investigate a culturally adapted brief negotiational intervention for alcohol use in the emergency department in Tanzania. Trials. 2022 Feb 5;23(1):120. doi: 10.1186/s13063-022-06060-y.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Catherine A Staton, MD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PPKAY (brief intervention), Standard Booster and Personalized Booster in people with Alcohol Use Disorder and Injury Traumatic, run by Duke University at 1 site in Tanzania.

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 4 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: finished, as of the sponsor's last update on 4 Nov 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 Tanzania. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Binge Drinking Days (Previous 4 Weeks) (time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 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 NCT04535011, which also lists 3 linked publications.

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 4 Nov 2026.