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BACKGROUND: Differentiated service delivery (DSD) increases antiretroviral therapy (ART) access in sub-Saharan Africa by moving clients out of congested ART clinics to communities for care. However, DSD settings challenge provider adherence to complex, chronic care treatment guidelines and have burdensome systems for client monitoring and evaluation (M&E), reducing data for decision-making. Electronic medical record systems (EMRS) improve client outcomes and reduce M&E workload. Traditional EMRS cannot operate in most DSD settings with unreliable power and poor connectivity. OBJECTIVE: This study aims to detail the human-centered design (HCD) process of developing a mobile EMRS for community-based DSD services in Lilongwe, Malawi. METHODS: Lighthouse Trust (LT) operates 2 Ministry of Health (MoH) clinics in Lilongwe, Malawi, with a combined total of >35,000 ART clients. LT's real-time, point-of-care EMRS collects complex client M&E data and provides decision-making support, ensuring adherence to integrated HIV and tuberculosis guidelines that optimize client and program outcomes. LT's EMRS scaled to all large MoH ART clinics. LT also implements a nurse-led community-based ART program (NCAP), a DSD model to provide ART and rapid assessment for 2400 stable LT clients in the community. LT, alongside collaborators, from the University of Washington's International Training and Education Center for Health and technology partner, Medic, used the open-source Community Health Toolkit (CHT) and HCD to develop an open-source, offline-first, mobile EMRS-like app, "community-based ART retention and suppression" (CARES). CARES aims to bring EMRS-like provider benefits to NCAP's DSD clients. RESULTS: CARES design took approximately 12 months and used an iterative process of highly participatory feedback sessions with provider, data manager, and M&E team inputs to ensure CARES optimization for the NCAP and LT settings. The CARES mobile EMRS prototype supports NCAP providers with embedded prompts and alerts to ensure adherence to integrated MoH ART guidelines, aiming to improve the quality of client care. CARES facilitates improved data quality and flow for NCAP M&E, aiming to reduce data gaps between community and clinic settings. The CARES pilot demonstrates the potential of a mobile, point-of-care EMRS-like app that could benefit NCAP clients, providers, and program teams with integrated client care and complete M&E data for decision-making. CARES challenges include app speed, search features to align longitudinal records, and CARES to EMRS integration that supports timely care alerts. CONCLUSIONS: Leveraging the CHT and HCD processes facilitated the design of a locally specified and optimized mobile app with the promise to bring EMRS-like benefits to DSD settings. Moving from the CARES prototype to routine NCAP implementation should result in improved client care and strengthened M&E while reducing workload. Our transparent and descriptive process shares the progress and pitfalls of the CARES design and development, helping others in this digital innovation area to learn from our experiences at this stage.
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Adult medical male circumcision (MC) is safe: global notifiable adverse event (AE) rates average below 2.0%. With Zimbabwe's shortage of health care workers (HCWs) compounded by COVID-19 constraints, two-way text-based (2wT) MC follow-up may be advantageous over routinely scheduled in-person reviews. A 2019 randomized control trial (RCT) found 2wT to be safe and efficient for MC follow-up. As few digital health interventions successfully transition from RCT to scale, we detail the 2wT scale-up approach from RCT to routine MC practice comparing MC safety and efficiency outcomes. After the RCT, 2wT transitioned from a site-based (centralized) system to hub-and-spoke model for scale-up where one nurse triaged all 2wT patients, referring patients in need to their local clinic. No post-operative visits were required with 2wT. Routine patients were expected to attend at least one post-operative review. We compare 1) AEs and in-person visits between 2wT men from RCT and routine MC service delivery; and 2) 2wT-based and routine follow-up among adults during the 2wT scale-up period, January to October 2021. During scale-up period, 5084 of 17417 adult MC patients (29%) opted into 2wT. Of the 5084, 0.08% (95% CI: 0.03, 2.0) had an AE and 71.0% (95% CI: 69.7, 72.2) responded to ≥1 daily SMS, a significant decrease from the 1.9% AE rate (95% CI: 0.7, 3.6; p<0.001) and 92.5% response rate (95% CI: 89.0, 94.6; p<0.001) from 2wT RCT men. During scale-up, AE rates did not differ between routine (0.03%; 95% CI: 0.02, 0.08) and 2wT (p = 0.248) groups. Of 5084 2wT men, 630 (12.4%) received telehealth reassurance, wound care reminders, and hygiene advice via 2wT; 64 (19.7%) were referred for care of which 50% had visits. Similar to RCT outcomes, routine 2wT was safe and provided clear efficiency advantages over in-person follow-up. 2wT reduced unnecessary patient-provider contact for COVID-19 infection prevention. Rural network coverage, provider hesitancy, and the slow pace of MC guideline changes slowed 2wT expansion. However, immediate 2wT benefits for MC programs and potential benefits of 2wT-based telehealth for other health contexts outweigh limitations.