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.

男性包皮环切术 (MC) 是一项重要的艾滋病毒预防干预措施，全球支持在亚 撒哈拉非洲 (SSA) 是安全的：SSA 的常规项目报告不良事件 (AE) 率远低于 2%。 然而，全球 MC 指南要求 14 天内进行一次或多次随访以检测 AE。 不良事件发生率低，诊所工作人员不堪重负，浪费宝贵的资源，对患者进行不必要的例行检查 没有并发症的MC客户无需支付交通费、旷工费和等待审核费， 阻碍 MC 的采用 在 SSA 薄弱的医疗系统中，MC 的质量在提供压力下表现不佳。 优质 MC 服务，实现每年 500 万 MC 的雄心勃勃的全球目标。 在患者和提供者之间采用双向短信 (2wT)，重点关注患有潜在 AE 的男性， 允许男性在没有并发症的情况下选择退出常规术后就诊，安全地减少了客户的数量。 访问量提高了 85%，这表明 2wT 可以在保持安全性的同时使 MC 服务显着提高效率。 2wT是否可以在其他常规程序设置中复制和扩展现在是一个关键的实现 南非共和国 (RSA) MC 的大量城市诊所、远程服务的背景。 在超过 500,000 次年度 MC 中， 在城市站点中可能会进行多达 100 万次多阶段、不必要的 MC 审查，这会导致服务。 交付瓶颈；在农村地区，后续工作需要多次、几个小时的行程，从而降低了 RSA 的生产力。 MC 扩张的压力和严重的卫生系统限制，加上良好的细胞覆盖率，表明 2wT 对 MC 护理质量和效率具有重大影响，尤其是在农村地区。 寻求开发适应性强的大规模 2wT 传播和实施模型 (2wT-2-SCALE) 首先，将严格进行随机对照试验（RCT）（第一阶段：测试）。 评估 2wT 如何提高城乡诊所的 AE 确定和随访效率 然后（阶段。 2：密集），我们通过为期一年的准实验性阶梯楔形设计和见解进行扩展（2wT-2-SCALE） 从与常规 MC 团队额外一年的 2wT 中获得（第 3 阶段：以实施为指导）。 科学上，我们采用混合方法来评估 2wT-2-SCALE 对我们特定的 VMMC 服务质量的影响。 目标是 1) 进行 RCT 以确定 2wT 如何增加 AE 确定，同时减少工作量 RSA 实施背景；2) 制定有效的大规模传播和实施策略 (2WT-2-SCALE) 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成本核算来估算付款人角度的预算和计划 与常规护理相比，2wT 规模扩大的影响这项实施研究是可行的、高度创新的。 以系统为重点，建立当地证据和及时的真实世界数据以支持进一步的适应， 采用和推广 2wT，以大规模提高 RSA 及其他领域高效、安全、高质量的 MC 服务。