Background: Voluntary medical male circumcisions (MCs) are safe: the majority of men heal without complication. However, guidelines require multiple follow-up visits. In Zimbabwe, where there is high mobile phone ownership, severe health care worker shortages, and rapid MC scale up intersect, we tested a 2-way texting (2wT) intervention to reduce provider workload while safeguarding patient safety. Setting: Two high-volume facilities providing MC near Harare, Zimbabwe. Methods: A prospective, unblinded, noninferiority, randomized control trial of 722 adult MC clients with cell phones randomized 1:1. 2wT clients (n = 362) responded to a daily text with in-person follow-up only if desired or an adverse event (AE) was suspected. The control group (n = 359) received routine in-person visits. All men were asked to return on postoperative day 14 for review. AEs at ≤day 14 visit and the number of in-person visits were compared between the groups. Results: Cumulative AEs were identified in 0.84% [95% confidence interval (CI): 0.28 to 2.43] among routine care men as compared with 1.88% (95% CI: 0.86 to 4.03) of 2wT participants. Noninferiority cannot be ruled out (95% CI: −∞ to +2.72); however, AE rates did not differ between the groups (P = 0.32). 2wT men attended an average of 0.30 visits as compared with 1.69 visits among routine care men, a significant reduction (P < 0.001). Conclusions: Although noninferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment. 2wT serves as a proxy for active surveillance, improving the quality of MC patient care. 2wT also reduced provider workload. 2wT provides an option for men to heal safely at home, returning to care when desired or if complications arise. 2wT should be further tested to enable widespread scale-up.

Background Voluntary medical male circumcision (MC) is safe and effective. Nevertheless, MC programs require multiple post-operative visits. In Zimbabwe, a randomized control trial (RCT) found that post-operative two-way texting (2wT) between clients and MC providers instead of in-person reviews reduced provider workload and safeguarded patient safety. A critical component of the RCT assessed usability and acceptability of 2wT among providers and clients. These findings inform scale-up of the 2wT approach to post-operative follow-up. Methods The RCT assigned 362 adult MC clients with cell phones into 2wT; these men responded to 13 automated daily texts supported by interactive texting or in-person follow-up, when needed. A subset of 100 texting clients filled a self-administered usability survey on day 14. 2wT acceptability was ascertained via 2wT response rates. Among 2wT providers, eight key informant interviews focused on 2wT acceptability and usability. Influences of wage and age on response rates and client-reported potential AEs were explored using linear and logistic regression models, respectively. Results Clients felt confident, comfortable, satisfied, and well-supported with 2wT-based follow-up; few noted texting challenges or concerns about healing. Clients felt 2wT saved them time and money. Response rates (92%) suggested 2wT acceptability. Both clients and providers felt 2wT was highly usable. Providers noted 2wT saved them time, empowered clients to

Objective Although adverse events (AEs) following voluntary medical male circumcision (VMMC) are rare, their prompt ascertainment and management is a marker of quality care. The use of two-way text messaging (2wT) for client follow-up after VMMC reduces the need for clinic visits (standard of care (SoC)) without compromising safety. We compared the cost-effectiveness of 2wT to SoC for post-VMMC follow-up in two, high-volume, public VMMC sites in Zimbabwe. Materials and methods We developed a decision-analytic (decision tree) model of post-VMMC client follow-up at two high-volume sites. We parameterized the model using data from both a randomized controlled study of 2wT vs. SoC and from the routine VMMC program. The perspective of analysis was the Zimbabwe government (payer). The time horizon covered the time from VMMC to wound healing. Costs included text messaging; both in-person and outreach follow-up; and AE management. Costs were estimated in 2018 U.S. dollars. The outcome of analysis was AE yield relative to the globally accepted safety standard of a 2% AE rate. We estimated the incremental cost per percentage increase in AE ascertainment and the incremental cost per additional AE identified. We conducted univariate and probabilistic sensitivity analyses.

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.

Introduction Ensuring quality service provision is fundamental to ZAZIC’s voluntary medical male circumcision (MC) program in Zimbabwe. From October, 2014 to September, 2017, ZAZIC conducted 205,847 MCs. Passive surveillance recorded a combined moderate and severe adverse event (AE) rate of 0.3%; reported adherence to follow-up was 95%, suggesting program safety. Despite encouraging passive surveillance data, verification of data quality and accuracy would increase confidence in AE identification. Methods From May to August, 2017, ZAZIC implemented a focused quality assurance (QA) study on AE ascertainment and documentation at 6 purposively-selected, high-volume MC sites. ZAZIC Gold-Standard (GS) clinicians prospectively observed 100 post-MC follow-ups per site in tandem with facility-based MC providers to confirm and characterize AEs, providing mentoring in AE management when needed. GS clinicians also retrospectively reviewed site-based, routine MC data, comparing recorded to reported AEs, and held brief qualitative interviews with site leadership on AE-related issues. Results Observed AE rates varied from 1–8%, potentially translating to thousands of unidentified AEs if observed AE rates were applied to previous MC performance. Most observed AEs were infections among younger clients. Retrospective review found discrepancies in AE documentation and reporting. Interviews suggest human resource and transport issues challenge MC follow-up visit attendance. Post-operative self-care appears to produce generally good results for adults; however, younger clients and guardians need additional attention to ensure quality care. There was no evidence of missed severe AEs resulting in permanent impairment or morbidity. Conclusions Although results cannot be generalized, active surveillance suggests that AEs may be higher and follow-up lower than reported. In response, ZAZIC’s Quality Assurance Task Force will replicate this QA study in other sites; increase training in AE identification, management, and documentation for clinical and data teams; and improve post-operative counseling for younger clients. Additional nurses and vehicles, especially in rural health clinics, could be beneficial.