Expanding and Scaling Two-way Texting to Reduce Unnecessary Follow-Up and Improve Adverse Event Identification Among Voluntary Medical Male Circumcision Clients in the Republic of South Africa

扩大和扩大双向短信，以减少南非共和国自愿医疗男性包皮环切术客户中不必要的后续行动并改善不良事件识别

• 批准号: 10011264
• 负责人: Caryl Feldacker
• 金额: $ 61.95万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-12 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10011264
• 关键词: AIDS prevention; Adherence; Adoption; Adverse event; Africa South of the Sahara; Blinded; Budgets; Caring; Cells; Client; Clinic; Complication; Cost Analysis; Data; Detection; Diffusion of Innovation; Disincentive; Economics; Effectiveness; Ensure; Goals; Gold; Guidelines; Health system; Healthcare Systems; Hour; Individual; Intervention; Maintenance; Male Circumcision; Measures; Medical; Methods; Modeling; Patients; Persons; Phase; Population; Postoperative Period; Preventive Intervention; Process Measure; Productivity; Protocols documentation; Provider; Province; Public Health; Quality of Care; Randomized; Reporting; Research; Research Design; Research Priority; Resources; Rural; Safety; Serious Adverse Event; Services; Severities; Site; South Africa; System; Testing; Text Messaging; Time; Uncertainty; Visit; Work; Workload; Zimbabwe; base; control trial; cost effective; cost estimate; cost outcomes; design; economic cost; evidence base; follow-up; healing; health care quality; high standard; implementation research; implementation science; implementation strategy; improved; innovation; insight; mHealth; men; microcosting; outreach; peri-urban; phase 1 testing; pressure; programs; prospective; response; routine care; rural area; scale up; service delivery; social; standard care; treatment arm; uptake; wasting

Male circumcision (MC) is a critical HIV prevention intervention with global support for expansion across sub- Saharan Africa (SSA). MC is safe: routine programs in SSA report adverse event (AE) rates well under 2%. Nevertheless, global MC guidelines require one or more follow-up visits within 14 days for AE detection. With low AE rates, overstretched clinic staff waste invaluable resources conducting unnecessary routine reviews for MC clients without complications. Men healing well needlessly pay for transport, miss work, and wait for reviews, discouraging MC uptake. In weak healthcare systems in SSA, MC quality is buckling under pressure to provide quality MC services and meet ambitious global targets of 5 million annual MCs. Our prior research in Zimbabwe employed two-way texting (2wT) between patients and providers to focus follow-up on men with potential AEs, allowing men healing without complication to opt-out of routine post-operative visits. 2wT safely reduced client visits by 85%, suggesting that 2wT can make MC services dramatically more efficient while maintaining safety. Whether 2wT can be replicated and scaled in other routine program settings is now a critical implementation research question. The Republic of South Africa’s (RSA) MC context of high-volume urban clinics, remote service delivery, and low AE identification threaten quality at scale. Across more than 500,000 annual MCs performed, up to 1 million multi-stage, unnecessary MC reviews are likely conducted. In urban sites, this causes service delivery bottlenecks; in rural areas, follow-up requires multiple, multi-hour trips, curtailing productivity. RSA pressure for MC expansion and severe health system constraints, combined with good cell coverage, suggest 2wT’s impact would be significant for MC care quality and efficiency, especially in rural areas. Therefore, we seek to develop an adaptable 2wT dissemination and implementation model at scale (2wT-2-SCALE) delivered by routine MC teams, not research teams. First, a randomized control trial (RCT) (phase 1: test) will rigorously evaluate how 2wT improves AE ascertainment and follow-up efficiency in urban and rural clinics. Then (phase 2: intensive), we scale (2wT-2-SCALE) via a one-year, quasi-experimental, step-wedge design with insights gained from one additional year of 2wT with routine MC teams (phase 3: maintain). Guided by implementation science, we employ mixed-methods to evaluate 2wT-2-SCALE’s impact on VMMC service quality. Our specific aims are to 1) conduct an RCT to determine how 2wT increases AE ascertainment while reducing workload in the RSA implementation context; 2) develop an effective dissemination and implementation strategy at scale (2WT-2-SCALE) using RE-AIM to evaluate program reach, effectiveness, adoption, implementation, and maintenance; and 3) use activity based micro-costing to estimate the payer-perspective budget and program impact from 2wT scale-up compared to routine care. This implementation research is feasible, highly innovative and systems-focused, establishing local evidence and timely, real-world data to support further adaptation, adoption, and spread of 2wT to improve efficient, safe, high-quality MC services at scale in RSA and beyond.

男性电路（MC）是一项关键的HIV预防干预措施，全球支持在子跨亚 撒哈拉非洲（SSA）。 MC是安全的：SSA报告广告活动（AE）的常规计划率低于2％。 然而，全球MC指南需要在14天内进行一次或多次随访才能检测。和 较低的AE费率，过度拉伸的诊所工作人员浪费了无价的资源，进行不必要的常规审查 MC客户没有并发症。男性康复良好 阻止MC吸收。在SSA的弱医疗保健系统中，MC质量在提供的压力下屈曲 高质量的MC服务，并满足雄心勃勃的全球年度目标。我们先前在津巴布韦的研究 在患者和提供者之间使用双向发短信（2WT），将后续行动集中在潜在的AE的男性上， 允许男性愈合而不会并发症，可以选择常规的术后访问。 2WT安全减少客户端 访问量增加了85％，这表明2WT可以使MC服务在保持安全性的同时更加高效。 现在是否可以在其他常规程序设置中复制和缩放2WT是关键的实现 研究问题。南非共和国（RSA）MC的高批量城市诊所的MC背景，远程服务 交付和低AE识别威胁着大规模的质量。在500,000多年的年度MC中， 可能会进行多达100万个多阶段，不必要的MC审查。在城市地点，这导致服务 递送瓶颈；在粗糙的地区，后续行动需要多次多小时旅行，降低生产力。 RSA MC扩展的压力和严重的卫生系统约束，结合良好的细胞覆盖范围，表明 2WT的影响对于MC护理质量和效率将很重要，尤其是在粗糙的地区。因此，我们 寻求按大规模开发适应性的2WT传播和实施模型（2WT-2级） 通过常规MC团队，而不是研究团队。首先，随机对照试验（RCT）（阶段1：测试）将严格 评估2WT如何提高城市和农村诊所的AE确定性和随访效率。然后（阶段） 2：密集型），我们通过一年的准实验，跨式设计，并进行洞察 与常规MC团队（第3阶段：维护）一起从2 WT的另外一年获得。以实施为指导 科学，我们员工混合方法评估了2WT-2级对VMMC服务质量的影响。我们的具体 目的是1）进行RCT，以确定2WT如何增加AE确定，同时减少工作量 RSA实现上下文； 2）大规模制定有效的传播和实施策略 （2WT-2级）使用Re-Aim评估计划范围，有效性，采用，实施和 维护; 3）使用基于活动的微观阶级来估计付款人预算和计划 与常规护理相比，2WT规模的影响。这项实施研究是可行的，高度创新的 以及以系统为中心的，建立当地证据和及时的现实数据，以支持进一步适应， 在RSA及其他地区，采用和扩散2WT，以提高高效，安全，高质量的MC服务。