Planned enrollment in feasibility of PRACT.

Introduction
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.
Materials and methods
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.
Results
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.
Conclusions
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
Trial registration numberNCT02828267. https://classic.clinicaltrials.gov/ct2/show/NCT02828267.

引言
资源匮乏地区往往缺乏酒精使用障碍治疗所需的人员与基础设施。本研究针对急诊科创伤患者，对简短磋商访谈（Brief Negotiational Interview, BNI）进行了文化适配，在坦桑尼亚推出了名为“减少饮酒以促进健康（Punguza Pombe Kwa Afya Yako, PPKAY）”的干预方案。本研究旨在评估针对PPKAY干预措施开展实用型自适应随机对照试验的可行性。

材料与方法
本可行性预试验采用单盲、平行组、自适应多阶段区组随机对照试验设计，后续将基于该试验确定伴或不伴短信强化干预的PPKAY方案在降低创伤患者饮酒量方面的最优疗效。本研究采用覆盖度（Reach）、有效性（Effectiveness）、采纳度（Adoption）、实施度（Implementation）、维持度（Maintenance）框架（RE-AIM）报告本可行性预试验结果，以入组率与保留率作为主要与次要结局指标。研究纳入在坦桑尼亚乞力马扎罗基督教医学中心因急性创伤就诊的成年患者，入组标准为：（1）酒精使用障碍识别测试（Alcohol Use Disorder Identification Test, AUDIT）得分≥8分；（2）伤前有饮酒行为；（3）入院时呼气酒精检测仪检测值≥0.0。干预组分为常规护理（usual care, UC）组、PPKAY组、PPKAY联合标准短信强化干预组，以及PPKAY联合个性化短信强化干预组。

结果
本研究共筛查181例患者，最终入组75例，6周、3个月及6个月随访率分别为80%、82.7%与84%，提示覆盖度与保留率符合预期。采纳度评估结果显示患者接受度极高，100%的患者认为该干预对自身行为产生了积极影响。实施与试验流程中，PPKAY依从率达76%，短信发送率达74%。参与研究的护士认为，这项耗时30分钟、低成本的干预措施及自适应临床试验具备推广与维持的可行性。

结论
本研究的干预措施与试验设计具备可行性与可接受性，且展现出良好的干预依从性，未出现方案执行的严重偏差。研究结果支持开展大规模试验，以评估护士主导的BNI干预方案PPKAY在低收入国家中的疗效。

试验注册
试验注册号：NCT02828267，详情见：https://classic.clinicaltrials.gov/ct2/show/NCT02828267。