PRACT w celu zbadania kontroli szkód związanych z alkoholem w środowisku o niskich dochodach; BI na oddziale ratunkowym w Tanzanii (PRACT)
PRAKTYKA: Pragmatyczne, randomizowane, adaptacyjne badanie kliniczne w celu zbadania kontroli szkód związanych z alkoholem w środowisku o niskich dochodach; Krótkie interwencje oddziału ratunkowego w Tanzanii
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.
Przegląd badań
Status
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Kilimanjaro
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Moshi, Kilimanjaro, Tanzania
- Kilimanjaro Christian Medical Centre
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: Usual Care
No prevention or educational information verbally or written coinciding with current usual care |
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Eksperymentalny: 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. |
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Eksperymentalny: 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. |
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Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Number of Binge Drinking Days (Previous 4 Weeks)
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Frequency of Alcohol Use (Previous 2 Weeks)
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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Reported as the number of drinking days during the past two weeks. |
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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Quantity of Alcohol Use (Previous 2 Weeks)
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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Reported as the number of drinks consumed during the past two weeks. |
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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Alcohol-related Harms Measured by the Drinker Inventory of Consequences (DrInC)
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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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
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AUDIT (Alcohol Use Disorder Identification Test) Score
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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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
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Depression as Measured by Patient Health Questionnaire 9 (PHQ-9)
Ramy czasowe: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
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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
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Catherine A Staton, MD, Duke University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Pro00103724
- R01AA027512 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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