{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T16:25:57Z","timestamp":1792427157708,"version":"4.5.0"},"update-to":[{"DOI":"10.1371\/journal.pmed.1004548","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T00:00:00Z","timestamp":1761868800000}}],"reference-count":43,"publisher":"Public Library of Science (PLoS)","issue":"10","license":[{"start":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T00:00:00Z","timestamp":1761523200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000027","name":"National Institute on Alcohol Abuse and Alcoholism","doi-asserted-by":"publisher","award":["R01 AA027512"],"award-info":[{"award-number":["R01 AA027512"]}],"id":[{"id":"10.13039\/100000027","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosmedicine.org"],"crossmark-restriction":false},"short-container-title":["PLoS Med"],"abstract":"\n Background<\/jats:title>\n \n Alcohol use contributes to over 3 million deaths annually. In Tanzania, there are no evidence-based culturally adapted interventions to address harmful alcohol use behaviors. Our hypothesis was that \u201c\n \n Punguza Pombe Kwa Afya Yako<\/jats:italic>\n <\/jats:italic>\n \u201d (PPKAY, Reduce Alcohol for your Health), a culturally adapted brief intervention with text-based boosters, is superior to usual care in reducing binge drinking at 3 months post discharge.\n <\/jats:p>\n <\/jats:sec>\n \n Methods and findings<\/jats:title>\n \n This manuscript reports. Stage 1 of our adaptive clinical trial which seeks to determine the effectiveness of the PPKAY+ booster to usual care; a subsequent stage will compare the PPKAY only to personalized and standard boosters. Adults who sought care for an acute injury at the Kilimanjaro Christian Medical Centre Emergency Department, self-disclosed alcohol use prior to the injury, scored \u22658 on the Alcohol Use Disorder Identification Test, and\/or test positive by alcohol breathalyzer were offered enrollment. Participants were randomly assigned to PPKAY+ boosters (personalized or standard) or usual care at 1:1:1 allocation. Primary analyses followed the intention-to-treat principle. The PPKAY is a 15-min nurse delivered brief intervention using motivational interviewing techniques combined with a standardized or personalized text based reminder sent weekly to participants after hospital discharge and until 1 year post enrollment compared to a usual care arm. Follow-up was performed by blinded outcome assessors. Our pooled intervention arms PPKAY+ boosters were compared to usual care to determine the effectiveness of the intervention in reducing the number of binge drinking days, the trial\u2019s primary outcome, in the previous 4 weeks at 3 months after discharge. A total of 1,484 patients were screened for eligibility between October 12th 2020, and on April 14th 2023. 448 patients met inclusion criteria and consented to participate. 148 were randomized to usual care, and 300 to the pooled intervention arm. Reasons for attrition included loss to follow-up (\n n<\/jats:italic>\n \u2009=\u200969), withdrawal (\n n<\/jats:italic>\n \u2009=\u20096), and deaths (\n n<\/jats:italic>\n \u2009=\u20094), with no differences between arms. Most participants were male (94%), from the Chagga tribe (59%) and had an average age of 36.4 years (SD 12.6) at baseline. At the 3-month follow-up, the intervention arm showed a notable reduction in mean predicted binge drinking days by 1.2 days (95% CI: [\u22122.3, \u22120.3];\n p<\/jats:italic>\n \u2009=\u20090.002) compared to the usual care group in a difference-in-differences analysis. Importantly, the self-reported nature of our primary outcome introduces the potential for social desirability bias, particularly in the absence of participant blinding, and should be considered a limitation when interpreting the findings.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n The reduction in binge drinking behavior at 3-month follow-up compared to usual care suggests our culturally adapted intervention is an effective alcohol intervention for patients acutely injured in Tanzania. According to the adaptive study design, the next phases of the trial will continue to compare the intervention arm with a paired down version without the text messages boosters.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n ClinicalTrials.gov\n NCT04535011<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pmed.1004548","type":"journal-article","created":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T17:55:43Z","timestamp":1761587743000},"page":"e1004548","update-policy":"https:\/\/doi.org\/10.1371\/journal.pmed.corrections_policy","source":"Crossref","is-referenced-by-count":5,"title":["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"],"prefix":"10.1371","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6468-2894","authenticated-orcid":true,"given":"Catherine A.","family":"Staton","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Minja","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4863-0071","authenticated-orcid":true,"given":"Joao Vitor Perez","family":"de Souza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1921-8424","authenticated-orcid":true,"given":"John A.","family":"Gallis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2282-4751","authenticated-orcid":true,"given":"Pollyana Coelho Pessoa","family":"Santos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7317-9492","authenticated-orcid":true,"given":"Mia","family":"Buono","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis","family":"Sakita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3692-5940","authenticated-orcid":true,"given":"Kennedy","family":"Ngowi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Boshe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley J.","family":"Phillips","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joao Ricardo Nickenig","family":"Vissoci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5550-1916","authenticated-orcid":true,"given":"Blandina T.","family":"Mmbaga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2025,10,27]]},"reference":[{"key":"pmed.1004548.ref001","volume-title":"Global status report on alcohol and health 2018","author":"World Health Organization","year":"2018"},{"issue":"1","key":"pmed.1004548.ref002","doi-asserted-by":"crossref","first-page":"50","DOI":"10.1186\/s13011-022-00479-x","article-title":"Missed opportunity for alcohol use disorder screening and management in primary health care facilities in northern rural Tanzania: a cross-sectional survey","volume":"17","author":"D Mushi","year":"2022","journal-title":"Subst Abuse Treat Prev Policy"},{"key":"pmed.1004548.ref003","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.alcohol.2019.06.001","article-title":"Perceptions of alcohol use among injury patients and their family members in Tanzanian society","volume":"83","author":"BJ Meier","year":"2020","journal-title":"Alcohol"},{"issue":"11","key":"pmed.1004548.ref004","doi-asserted-by":"crossref","first-page":"2266","DOI":"10.1111\/acer.14457","article-title":"Alcohol availability, cost, age of first drink, and its association with at-risk alcohol use in Moshi, Tanzania","volume":"44","author":"CA Staton","year":"2020","journal-title":"Alcohol Clin Exp Res"},{"issue":"1","key":"pmed.1004548.ref005","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1186\/s12889-018-5144-z","article-title":"The impact of alcohol among injury patients in Moshi, Tanzania: a nested case-crossover study","volume":"18","author":"CA Staton","year":"2018","journal-title":"BMC Public Health"},{"key":"pmed.1004548.ref006","unstructured":"World Health Organization. SAFER \u2013 alcohol control initiative [cited 22 Oct 2024]. Available from: https:\/\/www.who.int\/initiatives\/SAFER"},{"issue":"2","key":"pmed.1004548.ref007","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1016\/j.annemergmed.2012.02.006","article-title":"A brief intervention reduces hazardous and harmful drinking in emergency department patients","volume":"60","author":"G D\u2019Onofrio","year":"2012","journal-title":"Ann Emerg Med"},{"issue":"3","key":"pmed.1004548.ref008","doi-asserted-by":"crossref","first-page":"328","DOI":"10.1093\/alcalc\/agl016","article-title":"The efficacy of motivational interviewing as a brief intervention for excessive drinking: a meta-analytic review","volume":"41","author":"EI Vasilaki","year":"2006","journal-title":"Alcohol"},{"issue":"8","key":"pmed.1004548.ref009","doi-asserted-by":"crossref","first-page":"862","DOI":"10.1037\/adb0000318","article-title":"Motivational interviewing, enhancement, and brief interventions over the last decade: a review of reviews of efficacy and effectiveness","volume":"31","author":"CC DiClemente","year":"2017","journal-title":"Psychol Addict Behav"},{"issue":"1","key":"pmed.1004548.ref010","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1097\/00005650-200001000-00003","article-title":"Benefit-cost analysis of brief physician advice with problem drinkers in primary care settings","volume":"38","author":"MF Fleming","year":"2000","journal-title":"Med Care"},{"issue":"6","key":"pmed.1004548.ref011","doi-asserted-by":"crossref","first-page":"627","DOI":"10.1197\/aemj.9.6.627","article-title":"Preventive care in the emergency department: screening and brief intervention for alcohol problems in the emergency department: a systematic review","volume":"9","author":"G D\u2019Onofrio","year":"2002","journal-title":"Acad Emerg Med"},{"issue":"1","key":"pmed.1004548.ref012","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1080\/08897077.2018.1550465","article-title":"Use of non-face-to-face modalities for emergency department screening, brief intervention, and referral to treatment (ED-SBIRT) for high-risk alcohol use: a scoping review","volume":"40","author":"BJ Biroscak","year":"2019","journal-title":"Subst Abus"},{"issue":"1","key":"pmed.1004548.ref013","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1080\/14659891.2019.1664662","article-title":"Rarity and limited geographical coverage of individual level alcohol interventions in sub Saharan Africa: findings from a scoping review","volume":"25","author":"JM Francis","year":"2019","journal-title":"J Subst Use"},{"issue":"6","key":"pmed.1004548.ref014","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0099463","article-title":"The effectiveness of alcohol screening and brief intervention in emergency departments: a multicentre pragmatic cluster randomized controlled trial","volume":"9","author":"C Drummond","year":"2014","journal-title":"PLoS One"},{"key":"pmed.1004548.ref015","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.e8501","article-title":"Effectiveness of screening and brief alcohol intervention in primary care (SIPS trial): pragmatic cluster randomised controlled trial","volume":"346","author":"E Kaner","year":"2013","journal-title":"BMJ"},{"issue":"6","key":"pmed.1004548.ref016","doi-asserted-by":"crossref","first-page":"806","DOI":"10.15288\/jsa.2001.62.806","article-title":"Evaluating the effects of a brief motivational intervention for injured drinkers in the emergency department","volume":"62","author":"R Longabaugh","year":"2001","journal-title":"J Stud Alcohol"},{"issue":"6","key":"pmed.1004548.ref017","doi-asserted-by":"crossref","first-page":"664","DOI":"10.1016\/j.annemergmed.2014.06.010","article-title":"A text message alcohol intervention for young adult emergency department patients: a randomized clinical trial","volume":"64","author":"B Suffoletto","year":"2014","journal-title":"Ann Emerg Med"},{"issue":"11","key":"pmed.1004548.ref018","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pgph.0000410","article-title":"Feasibility of SMS booster for alcohol reduction in injury patients in Tanzania","volume":"2","author":"CA Staton","year":"2022","journal-title":"PLOS Glob Public Health"},{"issue":"1","key":"pmed.1004548.ref019","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1186\/s13063-022-06060-y","article-title":"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","volume":"23","author":"CA Staton","year":"2022","journal-title":"Trials"},{"key":"pmed.1004548.ref020","first-page":"119","volume-title":"World health statistics 2023: monitoring health for the SDGs, sustainable development goals","author":"World Health Organization","year":"2023"},{"issue":"10","key":"pmed.1004548.ref021","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0140041","article-title":"The epidemiology of alcohol use and alcohol use disorders among young people in Northern Tanzania","volume":"10","author":"JM Francis","year":"2015","journal-title":"PLoS One"},{"issue":"1","key":"pmed.1004548.ref022","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1080\/17457300.2015.1061562","article-title":"A prospective registry evaluating the epidemiology and clinical care of traumatic brain injury patients presenting to a regional referral hospital in Moshi, Tanzania: challenges and the way forward","volume":"24","author":"CA Staton","year":"2017","journal-title":"Int J Inj Contr Saf Promot"},{"key":"pmed.1004548.ref023","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.h2147","article-title":"The PRECIS-2 tool: designing trials that are fit for purpose","volume":"350","author":"K Loudon","year":"2015","journal-title":"BMJ"},{"key":"pmed.1004548.ref024","doi-asserted-by":"crossref","unstructured":"Phillips AJ, Menegassi VM, Oliveira NN, Rocha TAH, Vissoci JRN, de Souza JVP, et al. Translation and adaptation of the brief negotiation interview adherence scale for the Tanzanian culture. 2023. https:\/\/doi.org\/10.31219\/osf.io\/5g86r","DOI":"10.31219\/osf.io\/5g86r"},{"key":"pmed.1004548.ref025","author":"G D\u2019Onofrio","year":"2004"},{"issue":"2","key":"pmed.1004548.ref026","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pgph.0004200","article-title":"Using the ADAPT guidance to culturally adapt a brief intervention to reduce alcohol use among injury patients in Tanzania","volume":"5","author":"CA Staton","year":"2025","journal-title":"PLOS Glob Public Health"},{"key":"pmed.1004548.ref027","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.jsat.2015.08.004","article-title":"A Systematic review on the effectiveness of brief interventions for alcohol misuse among adults in emergency departments","volume":"61","author":"MSH Landy","year":"2016","journal-title":"J Subst Abuse Treat"},{"key":"pmed.1004548.ref028","author":"WR Miller","year":"1995","journal-title":"The Drinker Inventory of Consequences (DrInC). American Psychological Association (APA)"},{"issue":"11","key":"pmed.1004548.ref029","article-title":"Clinical evaluation of the alcohol use disorders identification test (AUDIT) in Moshi, Tanzania","volume":"18","author":"JRN Vissoci","year":"2023","journal-title":"PLoS One"},{"issue":"9","key":"pmed.1004548.ref030","doi-asserted-by":"crossref","first-page":"606","DOI":"10.1046\/j.1525-1497.2001.016009606.x","article-title":"The PHQ-9: validity of a brief depression severity measure","volume":"16","author":"K Kroenke","year":"2001","journal-title":"J Gen Intern Med"},{"key":"pmed.1004548.ref031","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1007\/978-1-4612-0357-5_3","article-title":"Timeline follow-back.","author":"LC Sobell","year":"1992","journal-title":"Measuring Alcohol Consumption. Totowa, NJ: Humana Press"},{"issue":"3","key":"pmed.1004548.ref032","doi-asserted-by":"crossref","first-page":"891","DOI":"10.1111\/j.1541-0420.2009.01332.x","article-title":"On efficiency of constrained longitudinal data analysis versus longitudinal analysis of covariance","volume":"66","author":"K Lu","year":"2010","journal-title":"Biometrics"},{"key":"pmed.1004548.ref033","volume-title":"R: A Language and Environment for Statistical Computing","author":"R Core Team","year":"2021"},{"issue":"3","key":"pmed.1004548.ref034","article-title":"mice: multivariate imputation by chained equations in R","volume":"45","author":"S van Buuren","year":"2011","journal-title":"J Stat Soft"},{"issue":"7","key":"pmed.1004548.ref035","doi-asserted-by":"crossref","first-page":"1082","DOI":"10.1111\/add.12960","article-title":"A comparison of the efficacy of brief interventions to reduce hazardous and harmful alcohol consumption between European and non-European countries: a systematic review and meta-analysis of randomized controlled trials","volume":"110","author":"C Elzerbi","year":"2015","journal-title":"Addiction"},{"issue":"2","key":"pmed.1004548.ref036","article-title":"Effectiveness of brief alcohol interventions in primary care populations","volume":"2","author":"EF Kaner","year":"2018","journal-title":"Cochrane Database Syst Rev"},{"issue":"9","key":"pmed.1004548.ref037","doi-asserted-by":"crossref","first-page":"986","DOI":"10.1001\/archinte.165.9.986","article-title":"Reduction of alcohol consumption by brief alcohol intervention in primary care: systematic review and meta-analysis","volume":"165","author":"N Bertholet","year":"2005","journal-title":"Arch Intern Med"},{"issue":"1","key":"pmed.1004548.ref038","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1186\/1940-0640-9-13","article-title":"The efficacy-effectiveness distinction in trials of alcohol brief intervention","volume":"9","author":"N Heather","year":"2014","journal-title":"Addict Sci Clin Pract"},{"issue":"5","key":"pmed.1004548.ref039","doi-asserted-by":"crossref","first-page":"486","DOI":"10.1093\/alcalc\/agp031","article-title":"Severity of baseline alcohol use as a moderator of brief interventions in the emergency department","volume":"44","author":"FC Blow","year":"2009","journal-title":"Alcohol"},{"issue":"4","key":"pmed.1004548.ref040","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1016\/j.afjem.2022.08.001","article-title":"Injury characteristics and their association with clinical complications among emergency care patients in Tanzania","volume":"12","author":"A Zimmerman","year":"2022","journal-title":"Afr J Emerg Med"},{"issue":"2","key":"pmed.1004548.ref041","first-page":"63","article-title":"Screening and brief intervention in the emergency department","volume":"28","author":"G D\u2019Onofrio","year":"2004","journal-title":"Alcohol Res Health"},{"key":"pmed.1004548.ref042","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1016\/j.drugalcdep.2013.11.017","article-title":"Regression to the mean and alcohol consumption: a cohort study exploring implications for the interpretation of change in control groups in brief intervention trials","volume":"135","author":"J McCambridge","year":"2014","journal-title":"Drug Alcohol Depend"},{"issue":"1","key":"pmed.1004548.ref043","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1111\/j.1360-0443.2007.02032.x","article-title":"Regression to the mean in substance use disorder treatment research","volume":"103","author":"JW Finney","year":"2008","journal-title":"Addiction"}],"updated-by":[{"DOI":"10.1371\/journal.pmed.1004548","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T00:00:00Z","timestamp":1761868800000}}],"container-title":["PLOS Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pmed.1004548","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T18:10:40Z","timestamp":1761934240000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pmed.1004548"}},"subtitle":[],"editor":[{"given":"Charlotte","family":"Hanlon","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,10,27]]},"references-count":43,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2025,10,27]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pmed.1004548","relation":{},"ISSN":["1549-1676"],"issn-type":[{"value":"1549-1676","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,27]]}}}