- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04535011
PRØV for å undersøke kontroll av alkoholrelaterte skader i en lavinntektssituasjon; Legevakt BI i Tanzania (PRACT)
PRAKTISK: En pragmatisk randomisert adaptiv klinisk studie for å undersøke kontroll av alkoholrelaterte skader i en lavinntektssetting; Emergency Department korte intervensjoner i 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Kilimanjaro
-
Moshi, Kilimanjaro, Tanzania
- Kilimanjaro Christian Medical Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- ≥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.
Exclusion Criteria:
- do not speak the native Swahili language
- too ill or unable to communicate
- prior enrollment in this study
- decline informed consent.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Usual Care
No prevention or educational information verbally or written coinciding with current usual care |
|
|
Eksperimentell: PPKAY
One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use |
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. |
|
Eksperimentell: PPKAY with Standard Booster
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") |
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. 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. |
|
Eksperimentell: PPKAY with Personalized Booster
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].") |
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. 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Binge Drinking Days (Previous 4 Weeks)
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of Alcohol Use (Previous 2 Weeks)
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
Reported as the number of drinking days during the past two weeks. |
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
|
Quantity of Alcohol Use (Previous 2 Weeks)
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
Reported as the number of drinks consumed during the past two weeks. |
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
|
Alcohol-related Harms Measured by the Drinker Inventory of Consequences (DrInC)
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
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. |
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
|
AUDIT (Alcohol Use Disorder Identification Test) Score
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
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. |
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
|
Depression as Measured by Patient Health Questionnaire 9 (PHQ-9)
Tidsramme: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
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. |
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Catherine A Staton, MD, Duke University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00103724
- R01AA027512 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .