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: 10380078
• 负责人: Caryl Feldacker
• 金额: $ 56.19万
• 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/10380078
• 关键词: AIDS prevention; Adherence; Adoption; Adverse event; Africa South of the Sahara; Blinded; Budgets; Caring; Cells; Client; Clinic; Complication; Consolidated Framework for Implementation Research; Cost Analysis; Data; Detection; Diffusion of Innovation; Disincentive; Dissemination and Implementation; Economics; Ensure; Goals; Gold; Guidelines; Health system; Healthcare Systems; Hour; Individual; Intervention; Maintenance; Male Circumcision; Measures; Medical; Methods; Modeling; Patients; Persons; Phase; Population; Postoperative Period; Process Measure; Productivity; Protocols documentation; Provider; Province; Public Health; Quality of Care; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Reporting; Research; Research Design; Research Priority; Resources; Rural; Safety; Serious Adverse Event; Services; Severities; Site; South Africa; System; Testing; Time; Uncertainty; Visit; Work; Workload; Zimbabwe; base; cost effective; cost estimate; cost outcomes; design; dissemination strategy; economic cost; effectiveness evaluation; evidence base; follow-up; healing; health care quality; high standard; implementation barriers; implementation context; implementation research; implementation science; implementation strategy; improved; innovation; insight; mHealth; men; microcosting; outreach; peri-urban; phase 1 testing; pressure; preventive intervention; programs; prospective; provider adoption; response; routine care; rural area; scale up; service delivery; social; standard care; treatment arm; two way texting; 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)是一种关键的艾滋病毒预防干预措施，全球支持在亚 撒哈拉非洲(SSA)。MC是安全的：SSA中的常规程序报告不良事件(AE)发生率远低于2%。 然而，全球MC指南要求在14天内进行一次或多次随访以检测AE。使用 不良事件发生率低，超负荷的诊所工作人员浪费了宝贵的资源进行不必要的例行审查 无并发症的MC客户。康复得很好的人不必要地支付交通费，错过工作，等待审查， 抑制MC摄取。在SSA薄弱的医疗体系中，MC质量在提供 优质的MC服务，实现每年500万MC的雄心勃勃的全球目标。我们之前在津巴布韦的研究 在患者和提供者之间使用双向短信(2wT)来重点跟踪潜在的AEs男性， 允许男性在没有并发症的情况下康复，选择不进行常规的术后探视。2wt安全减少客户端 访问量减少了85%，这表明2wT可以显著提高MC服务的效率，同时保持安全。 2wT能否在其他常规程序设置中复制和扩展现在是一个关键实施 研究问题。南非共和国(RSA)MC背景下的大容量城市诊所，远程服务 交付和低声发射识别威胁到大规模的质量。在每年进行的50多万场MC中， 可能会进行多达100万次多阶段、不必要的MC审查。在城市站点，这导致了服务 交付瓶颈；在农村地区，后续工作需要多次、数小时的旅行，从而降低了生产率。RSA MC扩张的压力和严格的卫生系统限制，再加上良好的小区覆盖率，表明 2WT将对MC护理质量和效率产生重大影响，特别是在农村地区。因此，我们 寻求在交付的规模(2wT-2-Scale)上开发可适应的2wT传播和实施模式 由常规的MC团队，而不是研究团队。首先，随机对照试验(RCT)(阶段1：试验)将严格 评估2wT如何提高城乡诊所的AE确诊和随访效率。然后(阶段 2：集约型)，我们通过为期一年的准试验性阶梯式楔形设计进行扩展(2wT-2规模) 从常规MC团队额外一年的2wt中获得(阶段3：维护)。以实施为导向 科学，我们使用混合方法来评估2wT-2尺度对VMMC服务质量的影响。我们的特定 目标是1)进行RCT，以确定2wT如何在减少工作负载的同时增加AE确定 RSA实施背景；2)制定有效的大规模传播和实施战略 (2WT-2量表)使用RE-AIM评估计划的覆盖范围、有效性、采用、实施和 维护；以及3)使用基于作业的微观成本计算来估计支付者视角的预算和计划 与常规护理相比，2周纵向扩展带来的影响。本实施研究具有可行性、创新性强的特点 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，以在RSA及其他地区大规模改进高效、安全、高质量的MC服务。