Flax Valerie L, Rizvi Narjis, Charantimath Umesh, Jessani Saleem, Kavi Avinash, Saleem Sarah, Somannavar Manjunath, Goudar Shivaprasad S, Hannan Anika, McClure Elizabeth M, Thind Simal, Frasso Rosemary, Derman Richard
RTI International, 3040 E Cornwallis Road, Research Triangle Park, North Carolina, 27709, USA.
The Aga Khan University, National Stadium Road, Karachi, Karachi City, Sindh, Pakistan.
Gates Open Res. 2025 Jul 15;9:48. doi: 10.12688/gatesopenres.16352.1. eCollection 2025.
Anemia among women of reproductive age has remained highly prevalent globally. Intravenous (IV) iron is well tolerated and proven effective for treating postpartum iron deficiency anemia in high-income countries, but evidence from LMICs, where oral iron is standard treatment, is limited. The PRIORITY trial will test the effectiveness of IV iron compared to oral iron for postpartum women with moderate anemia in eight LMIC sites. An implementation research (IR) study will be conducted alongside the PRIORITY trial in India and Pakistan to gather information on the intervention characteristics and the implementation process, and to assess feasibility, acceptability, fidelity, and cost of implementation for providing IV iron to postpartum women with moderate iron deficiency anemia.
The PRIORITY IR study will use a mixed methods convergent parallel design guided by two frameworks: the Consolidated Framework for Implementation Research and Proctor's implementation outcomes. The IR study will be conducted in the Belagavi, India and Karachi, Pakistan PRIORITY trial sites. Participants will include postpartum women in the IV iron intervention arm of the trial, family members, health workers administering IV iron, hospital administrators, postpartum women who refuse to be part of the trial (Pakistan only), and postpartum women in the oral iron arm of the trial (India only). Data collection methods will include surveys, in-depth interviews, a supervision checklist, and a cost assessment. Survey and supervision checklist data will be analyzed descriptively. Interview data will be analyzed using a directed content analysis approach.
The PRIORITY IR study will contribute important information about implementation processes and strategies and feasibility, acceptability, fidelity, and costs for postpartum IV iron implementation. Results of the study can provide guidance for implementing effective anemia treatment in LMIC contexts with a high anemia burden.
NCT05590260 (21/10/2022), CTRI/2022/10/046632 (19/10/2022), CTRI/2023/05/053302 (31/05/2023).
全球范围内，育龄妇女贫血现象仍然极为普遍。在高收入国家，静脉注射铁剂耐受性良好，且已被证明对治疗产后缺铁性贫血有效，但在以口服铁剂为标准治疗方法的低收入和中等收入国家，相关证据有限。“优先项目”试验将在八个低收入和中等收入国家的试验点，对静脉注射铁剂与口服铁剂治疗中度贫血产后妇女的有效性进行测试。将在印度和巴基斯坦与“优先项目”试验同步开展一项实施研究（IR），以收集有关干预措施特点和实施过程的信息，并评估为中度缺铁性贫血产后妇女提供静脉注射铁剂的可行性、可接受性、保真度和实施成本。
“优先项目”实施研究将采用混合方法收敛平行设计，由两个框架指导：实施研究综合框架和普罗克特的实施结果框架。该实施研究将在印度贝拉加维市和巴基斯坦卡拉奇市的“优先项目”试验点进行。参与者将包括试验中静脉注射铁剂干预组的产后妇女、家庭成员、实施静脉注射铁剂的医护人员、医院管理人员、拒绝参与试验的产后妇女（仅在巴基斯坦）以及试验中口服铁剂组的产后妇女（仅在印度）。数据收集方法将包括调查、深入访谈、监督检查表和成本评估。调查和监督检查表数据将进行描述性分析。访谈数据将采用定向内容分析法进行分析。
“优先项目”实施研究将提供有关实施过程和策略以及产后静脉注射铁剂实施的可行性、可接受性、保真度和成本的重要信息。该研究结果可为在贫血负担较重的低收入和中等收入国家实施有效的贫血治疗提供指导。
NCT05590260（2022年10月21日），CTRI/2022/10/046632（2022年10月19日），CTRI/2023/05/053302（2023年5月31日）。
