REDCap mobile data collection: Using implementation science to explore the potential and pitfalls of a digital health tool in routine voluntary medical male circumcision outreach settings in Zimbabwe.

Background: Digital data collection tools improve data quality but are limited by connectivity. ZAZIC, a Zimbabwean consortium focused on scaling up male circumcision (MC) services, provides MC in outreach settings where both data quality and connectivity is poor. ZAZIC implemented REDCap Mobile app for data collection among roving ZAZIC MC nurses. To inform continued scale-up or discontinuation, this paper details if, how, and for whom REDCap improved data quality using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Methods: Data were collected for this retrospective, cross-sectional study for nine months, from July 2019 to March 2020, before COVID-19 paused MC services. Data completeness was compared between paper- and REDCap-based tools and between two ZAZIC partners using two sample, one-tailed t-tests. Results: REDCap reached all roving nurses who reported 26,904 MCs from 1773 submissions. REDCap effectiveness, as measured by data completeness, decreased from 89.2% in paper to 76.6% in REDCap app for Partner 1 (p < 0.001, 95% CI: -0.24, -0.12) but increased modestly from 86.2% to 90.3% in REDCap for Partner 2 (p = 0.05, 95% CI: -.007, 0.12). Adoption of REDCap was 100%; paper-based reporting concluded in October 2019. Implementation varied by partner and user. Maintenance appeared high. Conclusion: Although initial transition from paper to REDCap showed mixed effectiveness, post-hoc analysis from service resumption found increased REDCap data completeness across partners, suggesting locally-led momentum for REDCap-based data collection. Staff training, consistent mentoring, and continued technical support appear critical for continued use of digital health tools for quality data collection in rural Zimbabwe and similar low connectivity settings.

Transitioning a digital health innovation from research to routine practice: Two-way texting for male circumcision follow-up in Zimbabwe.

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.

Balancing competing priorities: Quantity versus quality within a routine, voluntary medical male circumcision program operating at scale in Zimbabwe.

BACKGROUND: Since 2013, the ZAZIC consortium supported the Zimbabwe Ministry of Health and Child Care (MOHCC) to implement a high quality, integrated voluntary medical male circumcision (VMMC) program in 13 districts. With the aim of significantly lowering global HIV rates, prevention programs like VMMC make every effort to achieve ambitious targets at an increasingly reduced cost. This has the potential to threaten VMMC program quality. Two measures of program quality are follow-up and adverse event (AE) rates. To inform further VMMC program improvement, ZAZIC conducted a quality assurance (QA) activity to assess if pressure to do more with less influenced program quality. METHODS: Key informant interviews (KIIs) were conducted at 9 sites with 7 site-based VMMC program officers and 9 ZAZIC roving team members. Confidentiality was ensured to encourage candid conversation on adherence to VMMC standards, methods to increase productivity, challenges to target achievement, and suggestions for program modification. Interviews were recorded, transcribed and analyzed using Atlas.ti 6. RESULTS: VMMC teams work long hours in diverse community settings to reach ambitious targets. Rotating, large teams of trained VMMC providers ensures meeting demand. Service providers prioritize VMMC safety procedures and implement additional QA measures to prevent AEs among all clients, especially minors. However, KIs noted three areas where pressure for increased numbers of clients diminished adherence to VMMC safety standards. For pre- and post-operative counselling, MC teams may combine individual and group sessions to reach more people, potentially reducing client understanding of critical wound care instructions. Second, key infection control practices may be compromised (handwashing, scrubbing techniques, and preoperative client preparation) to speed MC procedures. Lastly, pressure for client numbers may reduce prioritization of patient follow-up, while client-perceived stigma may reduce care-seeking. Although AEs appear well managed, delays in AE identification and lack of consistent AE reporting compromise program quality. CONCLUSION: In pursuit of ambitious targets, healthcare workers may compromise quality of MC services. Although risk to patients may appear minimal, careful consideration of the realities and risks of ambitious target setting by donors, ministries, and implementing partners could help to ensure that client safety and program quality is consistently prioritized over productivity.

Trust but verify: Is there a role for active surveillance in monitoring adverse events in Zimbabwe's large-scale male circumcision program?

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.

Correction: Timing of adverse events among voluntary medical male circumcision clients: Implications from routine service delivery in Zimbabwe.

[This corrects the article DOI: 10.1371/journal.pone.0203292.].

Timing of adverse events among voluntary medical male circumcision clients: Implications from routine service delivery in Zimbabwe.

BACKGROUND: Timing of routine follow-up visits after adult male circumcision (MC) differs by country and method. Most men do not attend all routine follow-up visits. This cross-sectional study aimed to further understanding of AE timing within a large-scale, routine, MC program to improve patient safety. METHODS: From 2013-2017, ZAZIC consortium performed 192,575 MCs in Zimbabwe; the reported adverse event (AE) rate was 0.3%. Three scheduled, routine, follow-up visits intend to identify AEs. For surgical MC, visits were days 2, 7 and 42 post-procedure. For PrePex (device-based), visits were days 7, 14 and 49. Descriptive statistics explored characteristics of those patients with AEs. For each MC method, chi-square tests were used to evaluate associations between AE timing (days from MC to AE diagnosis) and factors of interest (age, AE type, severity). RESULTS: Of 421 AEs, 290 (69%) were surgical clients: 55 (19%) AEs were ≤2 days post-MC; 169 (58%) between 3-7 days; 47 (16%) between days 8-14; and 19 (7%) were ≥15 post-MC. Among surgical clients, bleeding was most common AE on/before Day 2 while infections predominated in other follow-up periods (p<0.001). Younger surgical MC patients with AEs experienced AEs later than older clients (p<0.001). Among 131 (31%) PrePex clients with AEs, 46 (35%) were ≤2 days post-MC; 59 (45%) between 3-7 days; 16 (12%) between days 8-14; and 10 (7%) ≥15 post-MC. For PrePex clients, device displacements were more likely to occur early while late AEs were most commonly infections (p<0.001). CONCLUSION: Almost 23% of surgical and 8% of PrePex AEs occurred after Visit 2. Later AEs were likely infections. Clinicians, clients, and caregivers should be more effectively counseled that complications may arise after initial visits. Messages emphasizing attention to wound care until complete healing could help ensure client safety. Younger boys, ages 10-14, and their caregivers would benefit from improved, targeted, post-operative counseling.

Implementing voluntary medical male circumcision using an innovative, integrated, health systems approach: experiences from 21 districts in Zimbabwe.

BACKGROUND: Despite increased support for voluntary medical male circumcision (VMMC) to reduce HIV incidence, current VMMC progress falls short. Slow progress in VMMC expansion may be partially attributed to emphasis on vertical (stand-alone) over more integrated implementation models that are more responsive to local needs. In 2013, the ZAZIC consortium began implementation of a 5-year, integrated VMMC program jointly with Ministry of Health and Child Care (MoHCC) in Zimbabwe. OBJECTIVE: To explore ZAZIC's approach emphasizing existing healthcare workers and infrastructure, increasing program sustainability and resilience. METHODS: A process evaluation utilizing routine quantitative data. Interviews with key MoHCC informants illuminate program strengths and weaknesses. METHODS: A process evaluation utilizing routine quantitative data. Interviews with key MoHCC informants illuminate program strengths and weaknesses. RESULTS: In start-up and year 1 (March 2013-September, 2014), ZAZIC expanded from two to 36 static VMMC sites and conducted 46,011 VMMCs; 39,840 completed from October 2013 to September 2014. From October 2014 to September 2015, 44,868 VMMCs demonstrated 13% increased productivity. In October, 2015, ZAZIC was required by its donor to consolidate service provision from 21 to 10 districts over a 3-month period. Despite this shock, 57,282 VMMCs were completed from October 2015 to September 2016 followed by 44,414 VMMCs in only 6 months, from October 2016 to March 2017. Overall, ZAZIC performed 192,575 VMMCs from March 2013 to March, 2017. The vast majority of VMMCs were completed safely by MoHCC staff with a reported moderate and severe adverse event rate of 0.3%. CONCLUSION: The safety, flexibility, and pace of scale-up associated with the integrated VMMC model appears similar to vertical delivery with potential benefits of capacity building, sustainability and health system strengthening. These models also appear more adaptable to local contexts. Although more complicated than traditional approaches to program implementation, attention should be given to this country-led approach for its potential to spur positive health system changes, including building local ownership, capacity, and infrastructure for future public health programming.