Applying mathematical modelling to estimate the impact of COVID-19-related VMMC service disruptions on new HIV infections in Zimbabwe.

BACKGROUND: The COVID-19 pandemic has overwhelmed health systems with knock on effects on diagnosis, treatment, and care. To mitigate the impact, the government of Zimbabwe enforced a strict lockdown beginning 30 March 2020 which ran intermittently until early 2021. In this period, the Ministry of Health and Childcare strategically prioritized delivery of services leading to partial and full suspension of services considered non-essential, including HIV prevention. As a result, Voluntary Medical Male Circumcision (VMMC) services were disrupted leading to an 80% decline in circumcisions conducted in 2020. Given the efficacy of VMMC, we quantified the potential effects of VMMC service disruption on new HIV infections in Zimbabwe. METHODS: We applied the GOALS model to evaluate the impact of COVID-19-related disruptions on reducing new HIV infections over 30-years. GOALS is an HIV simulation model that estimates number of new HIV infections based on sexual behaviours of population groups. The model is parameterized based on national surveys and HIV program data. We hypothesized three coverage scenarios by 2030: scenario I - pre-COVID trajectory: 80% VMMC coverage; Scenario II - marginal COVID-19 impact: 60% VMMC coverage, and scenario III - severe COVID-19 impact: 45% VMMC coverage. VMMC coverage between 2020 and 2030 was linearly interpolated to attain the estimated coverage and then held constant from 2030 to 2050, and discounted outcomes at 3%. RESULTS: Compared to the baseline scenario I, in scenario II, we estimated that the disruption of VMMC services would generate an average of 200 (176-224) additional new infections per year and 7,200 new HIV infections over the next 30 years. For scenario III, we estimated an average of 413 (389-437) additional new HIV infections per year and 15,000 new HIV infections over the next 30 years. The disruption of VMMC services could generate additional future HIV treatment costs ranging from $27 million to $55 million dollars across scenarios II and III, respectively. CONCLUSION: COVID-19 disruptions destabilized delivery of VMMC services which could contribute to an additional 7,200 new infections over the next 30 years. Unless mitigated, these disruptions could derail the national goals of reducing new infections by 2030.

HIV Incidence by Male Circumcision Status From the Population-Based HIV Impact Assessment Surveys-Eight Sub-Saharan African Countries, 2015-2017.

BACKGROUND: Male circumcision (MC) offers men lifelong partial protection from heterosexually acquired HIV infection. The impact of MC on HIV incidence has not been quantified in nationally representative samples. Data from the population-based HIV impact assessments were used to compare HIV incidence by MC status in countries implementing voluntary medical MC (VMMC) programs. METHODS: Data were pooled from population-based HIV impact assessments conducted in Eswatini, Lesotho, Malawi, Namibia, Tanzania, Uganda, Zambia, and Zimbabwe from 2015 to 2017. Incidence was measured using a recent infection testing algorithm and analyzed by self-reported MC status distinguishing between medical and nonmedical MC. Country, marital status, urban setting, sexual risk behaviors, and mean population HIV viral load among women as an indicator of treatment scale-up were included in a random-effects logistic regression model using pooled survey weights. Analyses were age stratified (15-34 and 35-59 years). Annualized incidence rates and 95% confidence intervals (CIs) and incidence differences were calculated between medically circumcised and uncircumcised men. RESULTS: Men 15-34 years reporting medical MC had lower HIV incidence than uncircumcised men [0.04% (95% CI: 0.00% to 0.10%) versus 0.34% (95% CI: 0.10% to 0.57%), respectively; P value = 0.01]; whereas among men 35-59 years, there was no significant incidence difference [1.36% (95% CI: 0.32% to 2.39%) versus 0.55% (95% CI: 0.14% to 0.67%), respectively; P value = 0.14]. DISCUSSION: Medical MC was associated with lower HIV incidence in men aged 15-34 years in nationally representative surveys in Africa. These findings are consistent with the expected ongoing VMMC program impact and highlight the importance of VMMC for the HIV response in Africa.

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.

Does peer education go beyond giving reproductive health information? Cohort study in Bulawayo and Mount Darwin, Zimbabwe.

OBJECTIVE: Peer education is an intervention within the voluntary medical male circumcision (VMMC)-adolescent sexual reproductive health (ASRH) linkages project in Bulawayo and Mount Darwin, Zimbabwe since 2016. Little is known if results extend beyond increasing knowledge. We therefore assessed the extent of and factors affecting referral by peer educators and receipt of HIV testing services (HTS), contraception, management of sexually transmitted infections (STIs) and VMMC services by young people (10-24 years) counselled. DESIGN: A cohort study involving all young people counselled by 95 peer educators during October-December 2018, through secondary analysis of routinely collected data. SETTING: All ASRH and VMMC sites in Mt Darwin and Bulawayo. PARTICIPANTS: All young people counselled by 95 peer educators. OUTCOME MEASURES: Censor date for assessing receipt of services was 31 January 2019. Factors (clients' age, gender, marital and schooling status, counselling type, location, and peer educators' age and gender) affecting non-referral and non-receipt of services (dependent variables) were assessed by log-binomial regression. Adjusted relative risks (aRRs) were calculated. RESULTS: Of the 3370 counselled (66% men), 65% were referred for at least one service. 58% of men were referred for VMMC. Other services had 5%-13% referrals. Non-referral for HTS decreased with clients' age (aRR: ~0.9) but was higher among group-counselled (aRR: 1.16). Counselling by men (aRR: 0.77) and rural location (aRR: 0.61) reduced risks of non-referral for VMMC, while age increased it (aRR ≥1.59). Receipt of services was high (64%-80%) except for STI referrals (39%). Group counselling and rural location (aRR: ~0.52) and male peer educators (aRR: 0.76) reduced the risk of non-receipt of VMMC. Rural location increased the risk of non-receipt of contraception (aRR: 3.18) while marriage reduced it (aRR: 0.20). CONCLUSION: We found varying levels of referral ranging from 5.1% (STIs) to 58.3% (VMMC) but high levels of receipt of services. Type of counselling, peer educators' gender and location affected receipt of services. We recommend qualitative approaches to further understand reasons for non-referrals and non-receipt of services.

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.

The emerging health impact of voluntary medical male circumcision in Zimbabwe: An evaluation using three epidemiological models.

BACKGROUND: Zimbabwe adopted voluntary medical male circumcision (VMMC) as a priority HIV prevention strategy in 2007 and began implementation in 2009. We evaluated the costs and impact of this VMMC program to date and in future. METHODS: Three mathematical models describing Zimbabwe's HIV epidemic and program evolution were calibrated to household survey data on prevalence and risk behaviors, with circumcision coverage calibrated to program-reported VMMCs. We compared trends in new infections and costs to a counterfactual without VMMC. Input assumptions were agreed in workshops with national stakeholders in 2015 and 2017. RESULTS: The VMMC program averted 2,600-12,200 infections (among men and women combined) by the end of 2016. This impact will grow as circumcised men are protected lifelong, and onward dynamic transmission effects, which protect women via reduced incidence and prevalence in their male partners, increase over time. If other prevention interventions remain at 2016 coverages, the VMMCs already performed will avert 24,400-69,800 infections (2.3-5% of all new infections) through 2030. If coverage targets are achieved by 2021 and maintained, the program will avert 108,000-171,000 infections (10-13% of all new infections) by 2030, costing $2,100-3,250 per infection averted relative to no VMMC. Annual savings from averted treatment needs will outweigh VMMC maintenance costs once coverage targets are reached. If Zimbabwe also achieves ambitious UNAIDS targets for scaling up treatment and prevention efforts, VMMC will reduce the HIV incidence remaining at 2030 by one-third, critically contributing to the UNAIDS goal of 90% incidence reduction. CONCLUSIONS: VMMC can substantially impact Zimbabwe's HIV epidemic in the coming years; this investment will save costs in the longer term.

Scale-Up of Voluntary Medical Male Circumcision Services for HIV Prevention - 12 Countries in Southern and Eastern Africa, 2013-2016.

Countries in Southern and Eastern Africa have the highest prevalence of human immunodeficiency virus (HIV) infection in the world; in 2015, 52% (approximately 19 million) of all persons living with HIV infection resided in these two regions.* Voluntary medical male circumcision (VMMC) reduces the risk for heterosexually acquired HIV infection among males by approximately 60% (1). As such, it is an essential component of the Joint United Nations Programme on HIV/AIDS (UNAIDS) strategy for ending acquired immunodeficiency syndrome (AIDS) by 2030 (2). Substantial progress toward achieving VMMC targets has been made in the 10 years since the World Health Organization (WHO) and UNAIDS recommended scale-up of VMMC for HIV prevention in 14 Southern and Eastern African countries with generalized HIV epidemics and low male circumcision prevalence (3).† This has been enabled in part by nearly $2 billion in cumulative funding through the President's Emergency Plan for AIDS Relief (PEPFAR), administered through multiple U.S. governmental agencies, including CDC, which has supported nearly half of all PEPFAR-supported VMMCs to date. Approximately 14.5 million VMMCs were performed globally during 2008-2016, which represented 70% of the original target of 20.8 million VMMCs in males aged 15-49 years through 2016 (4). Despite falling short of the target, these VMMCs are projected to avert 500,000 HIV infections by the end of 2030 (4). However, UNAIDS has estimated an additional 27 million VMMCs need to be performed by 2021 to meet the Fast Track targets (2). This report updates a previous report covering the period 2010-2012, when VMMC implementing partners supported by CDC performed approximately 1 million VMMCs in nine countries (5). During 2013-2016, these implementing partners performed nearly 5 million VMMCs in 12 countries. Meeting the global target will require redoubling current efforts and introducing novel strategies that increase demand among subgroups of males who have historically been reluctant to undergo VMMC.

A systems-based assessment of the PrePex device adverse events active surveillance system in Zimbabwe.

BACKGROUND: Voluntary Medical Male Circumcision (VMMC) is an effective method for HIV prevention and the World Health Organization (WHO) has recommended its expansion in 14 African countries with a high prevalence of HIV and low prevalence of male circumcision. The WHO has recently pre-qualified the PrePex device, a non-surgical male circumcision device, which reduces procedure time, can increase acceptability of VMMC, and can expand the set of potential provider cadres. The PrePex device was introduced in Zimbabwe as a way to scale-up VMMC services in the country. With the rapid scale-up of the PrePex device, as well as other similar devices, a strong surveillance system to detect adverse events (AE) is needed to monitor the safety profile of these devices. We performed a systems-based evaluation of the PrePex device AE active surveillance system in Zimbabwe. METHODS: The evaluation was based on the Centers for Disease Control and Prevention's Updated Guidelines for Evaluating Public Health Surveillance Systems. We adapted these guidelines to fit our local context. The evaluation incorporated the review of the standard operating procedures and surveillance system documents. Additionally, structured, in-person interviews were performed with key stakeholders who were users of the surveillance system at various levels. These key stakeholders were from the Ministry of Health, implementing partners, and health facilities in Harare. RESULTS: Clients were requested to return to the facility for follow-up on days 7, 14 and 49 after placement of the device. In the event of a severe AE, a standard report was generated by the health facility and relayed to the Ministry of Health Child and Care and donor agencies through predefined channels within 24 hours of diagnosis. Clinic staff reported difficulties with the amount of documentation required to follow up with clients and to report AEs. The surveillance system's acceptability among users interviewed was high, and users were motivated to identify all possible AEs related to this device. The surveillance system was purely paper-based and both duplicate and discrepant reporting forms between sites were identified. CONCLUSION: The PrePex AE active surveillance system was well accepted among participants in the health system. However, the amount of documentation which was required to follow-up with patients was a major barrier within the system, and might lead to decreased timeliness and quality of reporting. A passive surveillance system supported by electronic reporting would improve acceptance of the program.

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.

Correction: Modeling Impact and Cost-Effectiveness of Increased Efforts to Attract Voluntary Medical Male Circumcision Clients Ages 20-29 in Zimbabwe.

[This corrects the article DOI: 10.1371/journal.pone.0164144.].

Correction: Modeling Costs and Impacts of Introducing Early Infant Male Circumcision for Long-Term Sustainability of the Voluntary Medical Male Circumcision Program.

[This corrects the article DOI: 10.1371/journal.pone.0159167.].

Modeling Impact and Cost-Effectiveness of Increased Efforts to Attract Voluntary Medical Male Circumcision Clients Ages 20-29 in Zimbabwe.

BACKGROUND: Zimbabwe aims to increase circumcision coverage to 80% among 13- to 29-year-olds. However, implementation data suggest that high coverage among men ages 20 and older may not be achievable without efforts specifically targeted to these men, incurring additional costs per circumcision. Scale-up scenarios were created based on trends in implementation data in Zimbabwe, and the cost-effectiveness of increasing efforts to recruit clients ages 20-29 was examined. METHODS: Zimbabwe voluntary medical male circumcision (VMMC) program data were used to project trends in male circumcision coverage by age into the future. The projection informed a base scenario in which, by 2018, the country achieves 80% circumcision coverage among males ages 10-19 and lower levels of coverage among men above age 20. The Zimbabwe DMPPT 2.0 model was used to project costs and impacts, assuming a US$109 VMMC unit cost in the base scenario and a 3% discount rate. Two other scenarios assumed that the program could increase coverage among clients ages 20-29 with a corresponding increase in unit cost for these age groups. RESULTS: When circumcision coverage among men ages 20-29 is increased compared with a base scenario reflecting current implementation trends, fewer VMMCs are required to avert one infection. If more than 50% additional effort (reflected as multiplying the unit cost by >1.5) is required to double the increase in coverage among this age group compared with the base scenario, the cost per HIV infection averted is higher than in the base scenario. CONCLUSIONS: Although increased investment in recruiting VMMC clients ages 20-29 may lead to greater overall impact if recruitment efforts are successful, it may also lead to lower cost-effectiveness, depending on the cost of increasing recruitment. Programs should measure the relationship between increased effort and increased ability to attract this age group.

Modeling Costs and Impacts of Introducing Early Infant Male Circumcision for Long-Term Sustainability of the Voluntary Medical Male Circumcision Program.

Voluntary medical male circumcision (VMMC) has been shown to be an effective prevention strategy against HIV infection in males [1-3]. Since 2007, the President's Emergency Plan for AIDS Relief (PEPFAR) has supported VMMC programs in 14 priority countries in Africa. Today several of these countries are preparing to transition their VMMC programs from a scale-up and expansion phase to a maintenance phase. As they do so, they must consider the best approaches to sustain high levels of male circumcision in the population. The two alternatives under consideration are circumcising adolescents 10-14 years old over the long term or integrating early infant male circumcision (EIMC) into maternal and child health programs. The paper presents an analysis, using the Decision Makers Program Planning Tool, Version 2.0 (DMPPT 2.0), of the estimated cost and impact of introducing EIMC into existing VMMC programs in several countries in eastern and southern Africa. Limited cost data exist for the implementation of EIMC, but preliminary studies, such as the one detailed in Mangenah, et al. [4-5], suggest that the cost of EIMC may be less than that of adolescent and adult male circumcision. If this is the case, then adding EIMC to the VMMC program will increase the number of circumcisions that need to be performed but will not increase the total cost of the program over the long term. In addition, we found that a delayed or slow start-up of EIMC would not substantially reduce the impact of adding it to the program or increase cumulative long-term costs, which should make introduction of EIMC more feasible and attractive to countries contemplating such a program innovation.

Evaluating Opportunities for Achieving Cost Efficiencies Through the Introduction of PrePex Device Male Circumcision in Adult VMMC Programs in Zambia and Zimbabwe.

BACKGROUND: Results from recent costing studies have put into question potential Voluntary Medical Male Circumcision (VMMC) cost savings with the introduction of the PrePex device. METHODS: We evaluated the cost drivers and the overall unit cost of VMMC for a variety of service delivery models providing either surgical VMMC or both PrePex and surgery using current program data in Zimbabwe and Zambia. In Zimbabwe, 3 hypothetical PrePex only models were also included. For all models, clients aged 18 years and older were assumed to be medically eligible for PrePex and uptake was based on current program data from sites providing both methods. Direct costs included costs for consumables, including surgical VMMC kits for the forceps-guided method, device (US $12), human resources, demand creation, supply chain, waste management, training, and transport. RESULTS: Results for both countries suggest limited potential for PrePex to generate cost savings when adding the device to current surgical service delivery models. However, results for the hypothetical rural Integrated PrePex model in Zimbabwe suggest the potential for material unit cost savings (US $35 per VMMC vs. US $65-69 for existing surgical models). CONCLUSIONS: This analysis illustrates that models designed to leverage PrePex's advantages, namely the potential for integrating services in rural clinics and less stringent infrastructure requirements, may present opportunities for improved cost efficiency and service integration. Countries seeking to scale up VMMC in rural settings might consider integrating PrePex only MC services at the primary health care level to reduce costs while also increasing VMMC access and coverage.

Comparative Cost Analysis of Surgical and PrePex Device Male Circumcision in Zimbabwe and Mozambique.

BACKGROUND: The PrePex device has proven to be safe for voluntary medical male circumcision (VMMC) in adults in several African countries. Costing studies were conducted as part of a PrePex/Surgery comparison study in Zimbabwe and a pilot implementation study in Mozambique. METHODS: The studies calculated per male circumcision unit costs using a cost-analysis approach. Both direct costs (consumable and nonconsumable supplies, device, personnel, associated staff training) and selected indirect costs (capital and support personnel costs) were calculated. RESULTS: The cost comparison in Zimbabwe showed a unit cost per VMMC of $45.50 for PrePex and $53.08 for surgery. The unit cost difference was based on higher personnel and consumable supplies costs for the surgical procedure, which used disposable instrument kits. In Mozambique, the costing analysis estimated a higher unit cost for PrePex circumcision ($40.66) than for surgery ($20.85) because of higher consumable costs, particularly the PrePex device and lower consumable supplies costs for the surgical procedure using reusable instruments. Supplies and direct staff costs contributed 87.2% for PrePex and 65.8% for surgical unit costs in Mozambique. DISCUSSION: PrePex device male circumcision could potentially be cheaper than surgery in Zimbabwe, especially in settings that lack the infrastructure and personnel required for surgical VMMC, and this might result in programmatic cost savings. In Mozambique, the surgical procedure seems to be less costly compared with PrePex mainly because of higher consumable supplies costs. With reduced device unit costs, PrePex VMMC could become more cost-efficient and considered as complementary for Mozambique's VMMC scale-up program.

A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe.

BACKGROUND: The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, procedure time, and cost) of the PrePex device compared to forceps-guided surgical circumcision. METHODS AND FINDINGS: This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the procedures. The PrePex device procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total procedure time for the PrePex device was approximately one-third of the total surgical procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025-4.53%), which were resolved with simple intervention. The AEs were device related, including 1 case of pain leading to device removal and 1 case of removal of the device. CONCLUSIONS: The trial supports previous studies' conclusions that the PrePex procedure is safe, quick, easy to apply, and effective in terms of procedure time as an alternative to traditional surgical circumcision. The PrePex device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe. TRIAL REGISTRATION: ClinicalTrials.gov NCT01956370.

A Reevaluation of the Voluntary Medical Male Circumcision Scale-Up Plan in Zimbabwe.

BACKGROUND: The voluntary medical male circumcision (VMMC) program in Zimbabwe aims to circumcise 80% of males aged 13-29 by 2017. We assessed the impact of actual VMMC scale-up to date and evaluated the impact of potential alterations to the program to enhance program efficiency, through prioritization of subpopulations. METHODS AND FINDINGS: We implemented a recently developed analytical approach: the age-structured mathematical (ASM) model and accompanying three-level conceptual framework to assess the impact of VMMC as an intervention. By September 2014, 364,185 males were circumcised, an initiative that is estimated to avert 40,301 HIV infections by 2025. Through age-group prioritization, the number of VMMCs needed to avert one infection (effectiveness) ranged between ten (20-24 age-group) and 53 (45-49 age-group). The cost per infection averted ranged between $811 (20-24 age-group) and $5,518 (45-49 age-group). By 2025, the largest reductions in HIV incidence rate (up to 27%) were achieved by prioritizing 10-14, 15-19, or 20-24 year old. The greatest program efficiency was achieved by prioritizing 15-24, 15-29, or 15-34 year old. Prioritizing males 13-29 year old was programmatically efficient, but slightly inferior to the 15-24, 15-29, or 15-34 age groups. Through geographic prioritization, effectiveness varied from 9-12 VMMCs per infection averted across provinces. Through risk-group prioritization, effectiveness ranged from one (highest sexual risk-group) to 60 (lowest sexual risk-group) VMMCs per infection averted. CONCLUSION: The current VMMC program plan in Zimbabwe is targeting an efficient and impactful age bracket (13-29 year old), but program efficiency can be improved by prioritizing a subset of males for demand creation and service availability. The greatest program efficiency can be attained by prioritizing young sexually active males and males whose sexual behavior puts them at higher risk for acquiring HIV.

Cost analysis of integrating the PrePex medical device into a voluntary medical male circumcision program in Zimbabwe.

BACKGROUND: Fourteen African countries are scaling up voluntary medical male circumcision (VMMC) for HIV prevention. Several devices that might offer alternatives to the three WHO-approved surgical VMMC procedures have been evaluated for use in adults. One such device is PrePex, which was prequalified by the WHO in May 2013. We utilized data from one of the PrePex field studies undertaken in Zimbabwe to identify cost considerations for introducing PrePex into the existing surgical circumcision program. METHODS AND FINDINGS: We evaluated the cost drivers and overall unit cost of VMMC at a site providing surgical VMMC as a routine service ("routine surgery site") and at a site that had added PrePex VMMC procedures to routine surgical VMMC as part of a research study ("mixed study site"). We examined the main cost drivers and modeled hypothetical scenarios with varying ratios of surgical to PrePex circumcisions, different levels of site utilization, and a range of device prices. The unit costs per VMMC for the routine surgery and mixed study sites were $56 and $61, respectively. The two greatest contributors to unit price at both sites were consumables and staff. In the hypothetical scenarios, the unit cost increased as site utilization decreased, as the ratio of PrePex to surgical VMMC increased, and as device price increased. CONCLUSIONS: VMMC unit costs for routine surgery and mixed study sites were similar. Low service utilization was projected to result in the greatest increases in unit price. Countries that wish to incorporate PrePex into their circumcision programs should plan to maximize staff utilization and ensure that sites function at maximum capacity to achieve the lowest unit cost. Further costing studies will be necessary once routine implementation of PrePex-based circumcision is established.