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

• Published in: PloS one 2023-08, Vol.18 (8), p.e0288458
• Main Authors: Staton, Catherine A, Friedman, Kaitlyn, Phillips, Ashley J, Minnig, Mary Catherine, Sakita, Francis M, Ngowi, Kennedy M, Suffoletto, Brian, Hirshon, Jon Mark, Swahn, Monica, Mmbaga, Blandina T, Vissoci, Joao Ricardo Nickenig
• Format: Article
• Language: English
• Subjects: Accuracy; Adult; Alcohol use; Alcoholism - therapy; Alcohols; Biology and Life Sciences; Clinical trials; Drinking of alcoholic beverages; Earth Sciences; Ecology and Environmental Sciences; Effectiveness; Emergency medical care; Emergency medical services; Enrollments; Evaluation; Feasibility Studies; Health aspects; Health care facilities; Humans; Informed consent; Injury prevention; Intervention; Interviews; Low income groups; Maintenance; Medical personnel; Medicine and Health Sciences; Mortality; Patients; People and Places; Physical Sciences; Pilot Projects; Primary care; Research and Analysis Methods; Retention; Short message service; Single-Blind Method; Social Sciences; Socioeconomic factors; Sustainability; Tanzania; Tanzania - epidemiology; Telemedicine
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0288458

Low-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. This 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. Overall, 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. Our 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 registration number NCT02828267. https://classic.clinicaltrials.gov/ct2/show/NCT02828267.