Evidence map›Paper›PMID 37535693›Full record

ArticlePloS one2023

Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania.

Catherine A Staton, Kaitlyn Friedman, Ashley J Phillips, Mary Catherine Minnig, Francis M Sakita, Kennedy M Ngowi, Brian Suffoletto, Jon Mark Hirshon, Monica Swahn, Blandina T Mmbaga and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02828267 (Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02828267 nacompletednot on this map

Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania

TypeinterventionalSponsorDuke UniversityRan2018 to 2019Enrolled75ConditionsAlcohol UseArmsBrief Negotiational Intervention, Standard Booster, Personalized Booster
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Catherine A StatonDivision of Emergency Medicine, Duke University School of Medicine, Durham, NC, United States of America.ORCID 0000-0002-6468-2894
Kaitlyn FriedmanDuke Global Health Institute, Duke University, Durham, NC, United States of America.
Ashley J PhillipsDivision of Emergency Medicine, Duke University School of Medicine, Durham, NC, United States of America.
Mary Catherine MinnigDuke Global Health Institute, Duke University, Durham, NC, United States of America.
Francis M SakitaKilimanjaro Christian Medical Centre, Moshi, Tanzania.
Kennedy M NgowiKilimanjaro Clinical Research Institute, Moshi, Tanzania.
Brian SuffolettoDepartment of Emergency Medicine, University of Pittsburgh School of Medicine, Pittbsurgh, PA, United States of America.
Jon Mark HirshonDepartment of Emergency Medicine, University of Maryland School of Medicine, Baltimore MD, United States of America.ORCID 0000-0002-5247-529X
Monica SwahnDepartment of Epidemiology, Georgia State University School of Public Health, Atlanta, GA, United States of America.
Blandina T MmbagaDuke Global Health Institute, Duke University, Durham, NC, United States of America.
Joao Ricardo Nickenig VissociDivision of Emergency Medicine, Duke University School of Medicine, Durham, NC, United States of America.

Funding

PRACT: A Pragmatic Randomized Adaptive Clinical Trial to Investigate Controlling Alcohol related harms in a Low-Income Setting; Emergency Department Brief Interventions in TanzaniaR01AA027512 · NIAAA · DUKE UNIVERSITY · PI STATON, CATHERINE ANN · 2020 to 2024
$3.1M
Intestinal exosomes in alcohol-induces liver injuryR01AA027532 · NIAAA · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI YOON, JE-HYUN · 2019 to 2023
$1.7M
Addressing High Risk Alcohol Use Amongst Injury Patients in an Emergency Department in TanzaniaK01TW010000 · FIC · DUKE UNIVERSITY · PI STATON, CATHERINE ANN · 2015 to 2018
$477k
FIC NIH HHS K01 TW010000NIAAA NIH HHS L30 AA025227NIAAA NIH HHS R01 AA027512NIAAA NIH HHS R01 AA027532
6 · The paper itself

Abstract

introductionLow-resourced settings often lack personnel and infrastructure for alcohol use disorder treatment. We culturally adapted a Brief Negotiational Interview (BNI) for Emergency Department injury patients, the "Punguza Pombe Kwa Afya Yako (PPKAY)" ("Reduce Alcohol For Your Health") in Tanzania. This study aimed to evaluate the feasibility of a pragmatic randomized adaptive controlled trial of the PPKAY intervention. MATERIALS AND

methodsThis feasibility trial piloted a single-blind, parallel, adaptive, and multi-stage, block-randomized controlled trial, which will subsequently be used to determine the most effective intervention, with or without text message booster, to reduce alcohol use among injury patients. We reported our feasibility pilot study using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, with recruitment and retention rates being our primary and secondary outcomes. We enrolled adult patients seeking care for an acute injury at the Kilimanjaro Christian Medical Center in Tanzania if they (1) exhibited an Alcohol Use Disorder Identification Test (AUDIT) ≥8, (2) disclosed alcohol use prior to injury, or (3) had a breathalyzer ≥0.0 on arrival. Intervention arms were usual care (UC), PPKAY, PPKAY with standard text booster, or a PPKAY with a personalized text booster.

resultsOverall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention. Adoption measures showed an overwhelmingly positive patient acceptance with 100% of patients perceiving a positive impact on their behavior. The Implementation and trial processes were performed with high rates of PPKAY fidelity (76%) and SMS delivery (74%). Intervention nurses believed Maintenance and sustainability of this 30-minute, low-cost intervention and adaptive clinical trial were feasible.

conclusionsOur intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol. Results suggest support for undertaking a full trial to evaluate the effectiveness of the PPKAY, a nurse-driven BNI in a low-income country.

trial registrationTrial registration number NCT02828267. https://classic.clinicaltrials.gov/ct2/show/NCT02828267.

Indexed as

AlcoholismAdaptive Clinical Trials as TopicAdultFeasibility StudiesHumansPilot ProjectsRandomized Controlled Trials as TopicSingle-Blind MethodTanzania

Identifiers

PMID37535693
PMCPMC10399826

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.