Herce Michael E, Cassidy Caitlin, Munson Alexandra, Edwards Jessie K, Rutstein Sarah E, Matoga Mitch, Kumwenda Chimwemwe, Simon Katherine R, van Oosterhout Joep J, Cox Carrie M, Kamanga Funny, Kumwenda Wiza, Phiri Sam, Rambiki Ethel, Thawani Agness, Huwa Jacqueline, Malewezi Bridget, Mvalo Tisu, Bula Agatha, Chinula Lameck, Hoffman Irving, Squibb Madeleine A, Nyirenda Rose K, Saidi Friday, Hosseinipour Mina C, Chagomerana Maganizo B
Institute for Global Health and Infectious Disease, School of Medicine, University of North Carolina, Chapel Hill, USA.
UNC Project-Malawi, University of North Carolina, Chapel Hill, USA.
Implement Sci Commun. 2025 Jul 28;6(1):78. doi: 10.1186/s43058-025-00762-5.
In Malawi and elsewhere in Africa, many children living with HIV are unaware of their status, often because of missed services for the prevention of vertical transmission of HIV (PVTH). Pregnant and breastfeeding women (PBFW) living with HIV frequently go without viral load (VL) monitoring and their infants miss key HIV testing milestones for early infant HIV diagnosis (EID). In Malawi, the current standard of care (SOC) involves mostly passive approaches to pediatric HIV diagnosis, relying on mothers presenting to health facilities with their infants. To reach PBFW living with HIV and their infants who miss critical HIV services and who are at higher risk for adverse HIV outcomes, including vertical transmission, we developed the "Point-of-care Active Case finding & Management" or "PAC-Man" model. PAC-Man uses a multifaceted implementation strategy involving task-shifted mobile teams to reach these mother-infant pairs (MIPs) with evidence-based point-of-care (POC) technology for EID and maternal VL testing in the community, linked to back-to-care and antiretroviral therapy (ART) services.
We will conduct a hybrid type III effectiveness-implementation incomplete stepped-wedge cluster-randomized trial in 12 clinics in Malawi over a 3-year period to test our strategy. Control periods will reflect SOC. Intervention periods will add PAC-Man to SOC. The primary outcome is reach of infant EID testing by age 6 months in the clinic population. Secondary outcomes include the proportion of infants newly diagnosed with HIV initiating ART and maternal VL testing reach. These outcomes will be assessed using routinely collected clinic data augmented with field surveys enrolling a sample of MIPs randomly selected from each clinic. Implementation outcomes of acceptability, adoption, fidelity, implementation, sustainability, cost, and scalability will be assessed using convergent mixed methods.
Study findings will offer new insights into the effects of differentiated, community-based services for reaching infants unaware of their HIV-positive status and their mothers and characterize the fit of the PAC-Man strategy with the national PVTH program. The study holds promise for improving access to EID and VL testing, and ART, for MIPs currently being missed by traditional facility-based approaches and could suggest a novel approach for use in real-world PVTH programs across Africa.
This study is registered at ClinicalTrials.gov, NCT06493357.
在马拉维和非洲其他地区，许多感染艾滋病毒的儿童并不知晓自己的感染状况，这通常是因为预防艾滋病毒垂直传播（PVTH）的服务缺失。感染艾滋病毒的孕妇和哺乳期妇女（PBFW）常常未接受病毒载量（VL）监测，她们的婴儿也错过了早期婴儿艾滋病毒诊断（EID）的关键检测节点。在马拉维，当前的标准治疗（SOC）大多采用被动方式进行儿科艾滋病毒诊断，依赖母亲带着婴儿前往医疗机构。为了接触到那些错过关键艾滋病毒服务且面临包括垂直传播在内的不良艾滋病毒后果风险更高的感染艾滋病毒的PBFW及其婴儿，我们开发了“即时护理主动病例发现与管理”或“吃豆人”模式。“吃豆人”模式采用多方面的实施策略，包括任务转移的流动团队，利用基于证据的即时护理（POC）技术，在社区为这些母婴对（MIP）提供EID检测和产妇VL检测，并与后续护理及抗逆转录病毒治疗（ART）服务相联系。
我们将在马拉维的12家诊所进行为期3年的混合型III期有效性 - 实施不完全阶梯式楔形整群随机试验，以检验我们的策略。对照期将反映SOC。干预期将在SOC基础上增加“吃豆人”模式。主要结局是诊所人群中6个月龄婴儿接受EID检测的比例。次要结局包括新诊断出感染艾滋病毒的婴儿开始接受ART的比例以及产妇VL检测的覆盖率。这些结局将通过常规收集的诊所数据，并辅以对从每个诊所随机抽取的MIP样本进行的现场调查来评估。将使用收敛性混合方法评估可接受性、采用率、保真度、实施情况、可持续性、成本和可扩展性等实施结局。
研究结果将为针对未意识到自己艾滋病毒阳性状况的婴儿及其母亲的差异化社区服务效果提供新见解，并描述“吃豆人”策略与国家PVTH项目的契合度。该研究有望改善目前被传统机构式方法遗漏的MIP获得EID和VL检测以及ART的机会，并可能为非洲各地实际的PVTH项目提出一种新方法。
本研究已在ClinicalTrials.gov注册，注册号为NCT06493357。
