Reducing provider workload while preserving patient safety via a 2-way texting intervention in Zimbabwe’s voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial

Background: Surgical male circumcision (MC) safely reduces risk of female-to-male HIV-1 transmission by up to 60%. The average rate of global moderate and severe adverse events (AEs) is 0.8%: 99% of men heal from MC without incident. To reach the 2016 global MC target of 20 million, productivity must double in countries plagued by severe healthcare worker shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health and Child Care and performed over 120,000 MCs. MC care in Zimbabwe requires in-person, follow-up visits at post-operative days 2,7, and 42. ZAZIC program adverse event rate is 0.4%; therefore, overstretched clinic staff conducted more than 200,000 unnecessary reviews for MC clients without complications. Methods: Through an un-blinded, prospective, randomized, control trial in two high-volume MC facilities, we will compare two groups of adult MC clients with cell phones randomized 1:1 into two groups: 1) routine care (control group N=361) and 2) clients who receive and respond to a daily text with in-person follow-up only if desired or if a complication is suspected (intervention N=361). If an intervention client responds affirmatively to any automated daily text with a suspected AE, an MC nurse will exchange manual, modifiable, scripted texts with the client to determine symptoms and severity, requesting an in-person visit if desired or warranted. Both arms will complete a study-specific, Day 14, in-person, follow-up review for verification of self-reports (intervention) and comparison (control). Data collection includes extraction of routine client MC records, study-specific database reports, and participant usability surveys. Intent-to-treat (ITT) analysis will explore differences between groups to determine if two-way texting (2wT) can safely reduce MC follow-up visits; estimate the cost savings associated with 2wT over routine MC follow-up; and assess the acceptability and feasibility of 2wT for scale-up. Discussion: It is expected that this mobile health intervention will be as safe as routine care while providing distinct advantages in efficiency, costs, and reduced healthcare worker burden. The success of this intervention could lead to adaptation and adoption of this intervention at the national level, increasing efficiency of MC scale up, reducing burdens on providers and patients. Clinical Trial Registration Number NCT03119337