"Endless opportunities": A qualitative exploration of facilitators and barriers to scale-up of two-way texting follow-up after voluntary medical male circumcision in Zimbabwe.

In Zimbabwe, the ZAZIC consortium employs two-way, text-based (2wT) follow-up to strengthen post-operative care for voluntary medical male circumcision (VMMC). 2wT scaled nationally with evidence of client support and strengthened follow-up. However, 2wT uptake among healthcare providers remains suboptimal. Understanding the gap between mobile health (mHealth) potential for innovation expansion and scale-up realization is critical for 2wT and other mHealth innovations. Therefore, we conducted an exploratory qualitative study with the objective of identifying 2wT program strengths, challenges, and suggestions for scale up as part of routine VMMC services. A total of 16 in-depth interviews (IDIs) with diverse 2wT stakeholders were conducted, including nurses, monitoring & evaluation teams, and technology partners-a combination of perspectives that provide new insights. We used both inductive and deductive coding for thematic analysis. Among 2wT drivers of expansion success, interviewees noted: 2wT care benefits for clients; effective hands-on 2wT training; ease of app use for providers; 2wT saved time and money; and 2wT strengthened client/provider interaction. For 2wT scale-up challenges, staff shortages; network infrastructure constraints; client costs; duplication of paper and electronic reporting; and complexity of digital tools integration. To improve 2wT robustness, respondents suggested: more staff training to offset turnover; making 2wT free for clients; using 2wT to replace paper VMMC reporting; integrating with routine VMMC reporting systems; and expanding 2wT to other health areas. High stakeholder participation in app design, implementation strengthening, and evaluation were appreciated. Several 2wT improvements stemmed from this study, including enrollment of multiple people on one number to account for phone sharing; 2wT inclusion of minors ages 15+; clients provided with $1 to offset SMS costs; and reduced SMS messages to clients. Continued 2wT mentoring for staff, harmonization of 2wT with Ministry e-health data systems, and increased awareness of 2wT's client and provider benefits will help ensure successful 2wT scale-up.

Working toward sustainability: Transitioning HIV programs from a USA-based organization to a local partner in Zimbabwe.

BACKGROUND: Despite the history of United States of America (USA)-based partners implementing global health programs in low- and middle-income countries (LMIC), future models for sustainable healthcare rely on local country ownership and leadership. Transition is the process of shifting programs towards country ownership, where local stakeholders plan, manage, and deliver health programs. Transition is not a singular event but a process which may include a phase where health programs are led and managed by local entities but still reliant on awards from international partners. This phase is scarcely described yet can impact long-term program sustainability if navigated poorly. This qualitative study examines the transition of Zimbabwe's voluntary medical male circumcision and HIV care and treatment services from management by a USA-based organization, the International Training and Education Center for Health (I-TECH), to management under a new Zimbabwean organization, the Zimbabwe Technical Assistance, Training and Education Centre for Health (Zim-TTECH). The primary objective of this paper is to explore challenges, successes, and lessons learned during this transition to inform other non-governmental organizations. METHODS: We conducted sixteen virtual, key informant interviews using purposeful sampling, identifying potential participants based on their role in the transition team (leadership, administrative, financial, or human resources) and willingness to consent to the study. We aimed for equal representation from USA-based, I-TECH headquarters staff and Zimbabwe-based, Zim-TTECH staff involved in the transition team. Data were analyzed in Atlas.Ti using deductive and inductive methods, followed by a thematic analysis guided by several frameworks for program transition and organizational change. RESULTS: Findings suggest five themes to guide transition: 1) Develop a vision and empower leadership for change by delegating clear roles and supporting local ownership; 2) Plan and strategize for transition in a manner that accounts for historical context; 3) Communicate with and inform stakeholders to understand transition perceptions, understand barriers to transition, and enable open communications related to risks and benefits; 4) Engage and mobilize staff by constructing necessary infrastructure and providing technical assistance as needed; and 5) Define short-term and long-term success. CONCLUSION: Transition processes were challenged by the local country context, compressed transition timelines, and all-or-nothing measures of transition success. Facilitators included strong staff capacity and a synergistic partnership model between Zim-TTECH and I-TECH. Global funders and international organizations should support local LMIC partners in their pathway to independence by removing restrictions on funding awards, including transitioning ownership mid-stream, and positioning leadership of international awards for in-country entities.

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.

Urethrocutaneous fistula following VMMC: a case series from March 2013 to October 2019 in ZAZIC's voluntary medical male circumcision program in Zimbabwe.

BACKGROUND: Urethrocutaneous fistula (subsequently, fistula) is a rare adverse event (AE) in voluntary medical male circumcision (VMMC) programs. Global fistula rates of 0.19 and 0.28 per 100,000 VMMCs were reported. Management of fistula can be complex and requires expert skills. We describe seven cases of fistula in our large-scale VMMC program in Zimbabwe. We present fistula rates; provide an overview of initial management, surgical interventions, and patient outcomes; discuss causes; and suggest future prevention efforts. RESULTS: Case details are presented on fistulas identified between March 2013 and October 2019. Among the seven fistula clients, ages ranged from 10 to 22 years; 6 cases were among boys under 15 years of age. All clients received surgical VMMC by trained providers in an outreach setting. Clients presented with fistulae 2-42 days after VMMC. Secondary infection was identified in 6 of 7 cases. Six cases were managed through surgical repair. The number of repair attempts ranged from 1 to 10. One case healed spontaneously with conservative management. Fistula rates are presented as cases/100,000 VMMCs. CONCLUSION: Fistula is an uncommon but severe AE that requires clinical expertise for successful management and repair. High-quality AE surveillance should identify fistula promptly and include consultation with experienced urologists. Strengthening provider surgical skills and establishment of standard protocols for fistula management would aid future prevention efforts in VMMC programs.

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.

Cost-effectiveness analysis of two-way texting for post-operative follow-up in Zimbabwe's voluntary medical male circumcision program.

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. RESULTS: 2wT increased the costs due to text messaging by $4.42 but reduced clinic visit costs by $2.92 and outreach costs by $3.61 -a net savings of $2.10. 2wT also increased AE ascertainment by 50% (92% AE yield in 2wT compared to 42% AE yield in SoC). Therefore, 2wT dominated SoC in the incremental analysis: 2wT was less costly and more effective. Results were generally robust to univariate and probabilistic sensitivity analysis. CONCLUSIONS: 2wT is cost-effective for post-VMMC follow-up in Zimbabwe. Countries in which VMMC is a high-priority HIV prevention intervention should consider this mHealth intervention to reduce overall cost per VMMC, increasing the likelihood of current and future VMMC program sustainability.

Usability and acceptability of a two-way texting intervention for post-operative follow-up for voluntary medical male circumcision in Zimbabwe.

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 engage in their healing, and closed gaps in MC service quality. For scale, providers reinforced good post-operative counseling on AEs and texting instructions. Wage and age did not influence text response rates or potential AE texts. CONCLUSION: Results strongly suggest that 2wT is highly usable and acceptable for providers and patients. Men with concerns solicited provider guidance and reassurance offered via text. Providers noted that men engaged proactively in their healing. 2wT between providers and patients should be expanded for MC and considered for other short-term care contexts. The trial is registered on ClinicalTrials.gov, trial NCT03119337, and was activated on April 18, 2017. https://clinicaltrials.gov/ct2/show/NCT03119337.

Reducing Provider Workload While Preserving Patient Safety: A Randomized Control Trial Using 2-Way Texting for Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program.

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.

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.

Incorporating Voluntary Medical Male Circumcision Into Traditional Circumcision Contexts: Experiences of a Local Consortium in Zimbabwe Collaborating With an Ethnic Group.

Employing voluntary medical male circumcision (VMMC) within traditional settings may increase patient safety and help scale up male circumcision efforts in sub-Saharan Africa. In Zimbabwe, the VaRemba are among the few ethnic groups that practice traditional male circumcision, often in suboptimal hygienic environments. ZAZIC, a local consortium, and the Zimbabwe Ministry of Health and Child Care (MoHCC) established a successful, culturally sensitive partnership with the VaRemba to provide safe, standardized male circumcision procedures and reduce adverse events (AEs) during traditional male circumcision initiation camps. The foundation for the VaRemba Camp Collaborative (VCC) was established over a 4-year period, between 2013 and 2017, with support from a wide group of stakeholders. Initially, ZAZIC supported VaRemba traditional male circumcisions by providing key commodities and transport to help ensure patient safety. Subsequently, 2 male VaRemba nurses were trained in VMMC according to national MoHCC guidelines to enable medical male circumcision within the camp. To increase awareness and uptake of VMMC at the upcoming August-September 2017 camp, ZAZIC then worked closely with a trained team of circumcised VaRemba men to create demand for VMMC. Non-VaRemba ZAZIC doctors were granted permission by VaRemba leaders to provide oversight of VMMC procedures and postoperative treatment for all moderate and severe AEs within the camp setting. Of 672 male camp residents ages 10 and older, 657 (98%) chose VMMC. Only 3 (0.5%) moderate infections occurred among VMMC clients; all were promptly treated and healed well. Although the successful collaboration required many years of investment to build trust with community leaders and members, it ultimately resulted in a successful model that paired traditional circumcision practices with modern VMMC, suggesting potential for replicability in other similar sub-Saharan African communities.

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.

Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe.

METHODS: We aimed to determine if the adverse event (AE) rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision. RESULTS: Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46); 79.5% in WHO stage 2; median CD4 was 336.5c/µl (IQR: 232, 459); 337 (85%) on anti-retroviral therapy. Among 385 (96%) observed completely healed, median days to complete healing was 42 (IQR: 35-49). There was no association between time to healing and CD4 (p = 0.66). Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5). This was non-inferior to 2% AEs (p = 0.0003). All AEs were device displacements resulting in surgical MC and, subsequently, complete healing. CONCLUSION: Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.

Adverse event profile of a mature voluntary medical male circumcision programme performing PrePex and surgical procedures in Zimbabwe.

INTRODUCTION: The frequency of adverse events (AEs) is a widely used indicator of voluntary medical male circumcision (VMMC) programme quality. Though over 11.7 million male circumcisions (MCs) have been performed, little published data exists on the profile of AEs from mature, large-scale programmes. No published data exists on routine implementation of PrePex, a device-based MC method. METHODS: The ZAZIC Consortium began implementing VMMC in Zimbabwe in 2013, supporting services at 36 facilities. Aggregate data on VMMC outputs are collected monthly from each facility. Detailed forms are completed describing the profile of each moderate and severe AE. Bivariate and multivariable analyses were conducted using log-binomial regression models. RESULTS: From October 2014 through September 2015, 44,868 clients were circumcised with 156 clients experiencing a moderate or severe AE. 96.2% of clients had a follow-up visit within 14 days of their procedure. AEs were uncommon, with 0.3% (116/41,416) of surgical and 1.2% (40/3,452) of PrePex clients experiencing a moderate or severe AE. After adjusting for VMMC site, we found that PrePex was associated with a 3.29-fold (95% CI: 1.78-6.06) increased risk of experiencing an AE compared to surgical procedures. Device displacements, when the PrePex device is intentionally or accidentally dislodged during the 7-day placement period, accounted for 70% of PrePex AEs. The majority of device displacements were intentional self-removals. Overall, infection was the most common AE among VMMC clients. Compared to clients aged 20 and above, clients aged 10-14 were 3.07-fold (95% CI: 1.36-6.91) more likely to experience an infection and clients aged 15-19 were 1.80-fold (95% CI: 0.82-3.92) more likely to experience an infection, adjusted for site. CONCLUSION: This exploratory analysis found that clients receiving PrePex were more likely to experience an AE than surgical circumcision clients. This is largely attributable to the occurrence of device displacements, which require prompt access to corrective surgical MC procedures as part of their clinical management. Most device displacements were self-removals which are preventable if client behaviour could be modified through counselling interventions. We also found that infection after MC is more common among younger clients, who may benefit from additional counselling or increased parental involvement.

Is it all about the money? A qualitative exploration of the effects of performance-based financial incentives on Zimbabwe's voluntary male medical circumcision program.

BACKGROUND: In 2013, Zimbabwe's voluntary medical male circumcision (VMMC) program adopted performance-based financing (PBF) to speed progress towards ambitious VMMC targets. The $25 USD PBF intended to encourage low-paid healthcare workers to remain in the public sector and to strengthen the public healthcare system. The majority of the incentive supports healthcare workers (HCWs) who perform VMMC alongside other routine services; a small portion supports province, district, and facility levels. METHODS: This qualitative study assessed the effect of the PBF on HCW motivation, satisfaction, and professional relationships. The study objectives were to: 1) Gain understanding of the advantages and disadvantages of PBF at the HCW level; 2) Gain understanding of the advantages and disadvantages of PBF at the site level; and 3) Inform scale up, modification, or discontinuation of PBF for the national VMMC program. Sixteen focus groups were conducted: eight with HCWs who received PBF for VMMC and eight with HCWs in the same clinics who did not work in VMMC and, therefore, did not receive PBF. Fourteen key informant interviews ascertained administrator opinion. RESULTS: Findings suggest that PBF appreciably increased motivation among VMMC teams and helped improve facilities where VMMC services are provided. However, PBF appears to contribute to antagonism at the workplace, creating divisiveness that may reach beyond VMMC. PBF may also cause distortion in the healthcare system: HCWs prioritized incentivized VMMC services over other routine duties. To reduce workplace tension and improve the VMMC program, participants suggested increasing HCW training in VMMC to expand PBF beneficiaries and strengthening integration of VMMC services into routine care. CONCLUSION: In the low-resource, short-staffed context of Zimbabwe, PBF enabled rapid VMMC scale up and achievement of ambitious targets; however, side effects make PBF less advantageous and sustainable than envisioned. Careful consideration is warranted in choosing whether, and how, to implement PBF to prioritize a public health program.