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Implementation Science

Adverse Event Trends Within a Large-Scale, Routine, Voluntary Medical Male Circumcision Program in Zimbabwe, 2014–2019

Victor, Omollo MPH, MBchBa; Phiona, Marongwe MPHb; Vernon, Murenje MBchBb; Thoko, Madoda BSNc; Paidamoyo, Gonouya MBchBb; Farai, Gwenzi MSc, MBAb; Joseph, Hove MBchBd; Munyaradzi, Tinashe MBchBc; Olbarn, Rutsito MBchB, McomBAd; Pesanai, Chatikobo MAc; Mufuta, Tshimanga PhDc; Vuyelwa, Sidile-Chitimbire MSc, MBAd; Sinokuthemba, Xaba MSc, RNe; Batsirai, Makunike-Chikwinya MBchB, MPHb; Marrianne, Holec MSf; Scott, Barnhart MD, MPHa,f,g; Feldacker, Caryl PhD, MPHa,f

Author Information
JAIDS Journal of Acquired Immune Deficiency Syndromes: October 1, 2021 - Volume 88 - Issue 2 - p 173-180
doi: 10.1097/QAI.0000000000002751
  • Open

Abstract

INTRODUCTION

Male circumcision (MC) is one the most common surgical procedures, globally; an estimated one-third of all males undergo MC.1 MC reduces risk of HIV acquisition in heterosexual men by 60% and, therefore, is a core component of the Joint United Nations Programme on HIV and AIDS strategy for eliminating AIDS by 2030.2–5 A recent meta-analysis of the association between MC and sexually transmitted infections among men who have sex with men found a 42% reduced odds of HIV infection among men who have sex with men in low-income and middle-income countries.6,7 Between 2008 and 2020, support from the US President's Emergency Plan for AIDS Relief (PEPFAR) helped fund more than 22.6 million MCs among men aged 10 years and above in 15 priority countries of East and Southern Africa, including South Sudan from 2018 onward.8

MC is safe when performed by trained qualified medical personnel. Reported adverse event (AE) rates in large, sub-Saharan African MC programs operating at scale are low, ranging from 0.1% to 8%.9–18 AE rates from passive surveillance, without patient tracing, report 0.8% AEs (range: 0.4–4.2),10,19–22 whereas AE rates with active surveillance (proactive patient follow-up) report higher AE rates, varying from 5% to 18%.16,23–25 Across programs, AE rates seem similar across the method and largely remain below the commonly accepted safety standard of 2% combined moderate and severe AEs (SAE).26–28 Among device-based MCs, such as PrePex, reported AEs are commonly due to device displacement, pain, and swelling.29–31 Surgical AEs are most commonly infection, swelling, pain, and bleeding.10,32 Moderate AEs from any method typically resolve swiftly with minimal clinical intervention.14,18,23 Although rare,33–36 SAEs from surgical MC, like fistulas, tetanus, or glans injuries, may result in permanent impairment.

Collecting, analyzing, and disseminating information on AE identification, management, and prevention is critical to inform global policies and update MC guidelines in support of safe MC practices. Recent changes highlight the need for routine, high-quality data from MC program operating at scale. In 2014, the global policy change recommended against the forceps-guided surgical procedure among men aged 10–14 because of higher risk of glans injuries, instead promoting the safer, but slower, dorsal slit procedure for both younger and older clients.37 Following reports of rare but fatal tetanus infections after PrePex-based MC, PrePex was discontinued.38,39 Additional longitudinal AE data from a large MC program operating at scale will contribute to local, regional, and global MC quality improvement efforts.

The ZAZIC consortium was formed in 2013 and named for its partner organizations: Zimbabwe Association of Church-Related Hospitals, Zimbabwe Community Health Intervention Research Project, and the International Training and Education Center for Health. ZAZIC implements an integrated approach to MC in partnership with the Zimbabwe Ministry of Health and Child Care (MoHCC).40 As of December 2019, ZAZIC performed over 480,000 medical MCs, about 30% of total MCs in Zimbabwe. ZAZIC's combined moderate or SAE rates were reported at 0.3% for surgical MCs and 1.2% for PrePex MCs.10 ZAZIC continuous quality improvement efforts consistently focus on improving AE identification, documentation, and reporting over time.11,24

This current article adds to the AE literature by describing the characteristics of AEs over 5 years of MC program operation at scale, from April, 2014 to December, 2019. We describe both the characteristics of patients with AEs and factors associated with experiencing a severe or moderate AE. Using a subset of available data (2017–2019), we also identify trends in AE rates by the MC method. Among the 15 MC priority countries with program data from 2008 to 2020, there is little comprehensive data on AEs from large, routine MC programs. Therefore, this article contributes to further understanding of AE patterns to ensure client safety and quality MC programming at scale.

METHODS

Population and Setting

Men aged 10 years and above who underwent voluntary medical male circumcisions between April 2014 and December 2019 are included. MCs were performed in 51 locations (33 outreach and 18 facilities) within 22 districts. In the routine ZAZIC program, 298,482 MCs were performed in outreach settings (eg, rural health centers, workplaces, mobile caravans, and tent-based clinics), whereas 182,940 were performed in static facilities, most commonly district hospitals. MCs are performed by trained MoHCC staff (medical doctors and nurses) from both static and rural health centers or by ZAZIC-specific clinical teams who augment MoHCC teams when demand is high.

MC Procedures

All ZAZIC MC practices and policies follow Zimbabwe MoHCC guidelines and respond swiftly to changes in recommendations based on MoHCC guidance. Three MC techniques were approved for use during the study period: Surgical dorsal slit (the recommended surgical method) was approved for all clients aged 10 years and above, surgical forceps–guided MC was approved only for clients aged 15 years and above, and PrePex device–based MC was approved for clients aged 18 years and above but discontinued in December 2016. Cumulatively, 462,165 MCs were performed using either the dorsal slit method or the forceps-guided method and 19,127 using PrePex. Adult clients were circumcised by the MC method of their choice, surgical or device-based, depending on eligibility and availability of devices. Clients were given the option of PrePex and surgical MC. For those who chose the surgical method, it was the clinician who determined his/her preferred method between forceps-guided and dorsal slit method. Most MCs were performed by nurses. Regardless of the method, clients were counseled to return for in-person, postoperative reviews for early AE detection on days 2 and 7 as well as a visit on day 42 to confirm healing. Attendance of at least 1 follow-up visit within 14 days of procedure is reported at over 95%. In line with MoHCC policy and global guidance, ZAZIC routine monthly and quarterly reports include the number of MCs, by age and method, and two indicators of quality care: number of clients with at least 1 follow-up visit within 14 days and AEs by MC method, AE type and AE severity.41

Data Collection and Definitions

Postoperative or postdevice placement follow-up visits are scheduled on days 2, 7, and 42 for surgical and days 7, 14, and 49 for PrePex, in accordance with Zimbabwe MoHCC guidelines. Details on AE type, day of AE identification, and severity were recorded in routine MoHCC MC and AE registers and client intake forms. Only moderate and SAEs are reported. Additional details are reported on the MoHCC AE report, a form with detailed client history, examination findings, management, and clinical outcomes. Moderate AEs are those that required clinical intervention (medication and pressure bandage), whereas SAEs are those that required hospitalization or surgical re-exploration.28

Data Analysis

Age was categorized according to PEPFAR reporting categories: 10–14, 15–19, and 20 years of age and older. The time to AE was calculated using the number of days between surgery or PrePex placement (day 0) and the day the client was identified with an AE at the clinic. The time to AE identification was categorized as occurring ≤2 days, 3–7 days, 8–14 days, and 15+ days as used previously,11 AE severity, and type adhered to standard PEPFAR definitions.28

We used χ2 tests to descriptively compare the characteristics of patients identified with AEs between April 2014 and December 2019 by the MC method. Univariate and multivariable analyses used log-binomial regression models with robust standard errors. Multivariable analyses used clustering by site. The rate of AEs was calculated by dividing the total number of AEs by the total number of MCs performed per year and per age group, expressing rates as AEs per 10,000 MCs. A Cochran-Armitage Trend Test using R version 3.6.1 (www.r-project.org)42 evaluated AE rate trends across years and age group for MCs between January 2015 and December 2019. Owing to data availability, AE rate trends by the MC method were available only for MCs between January 2017 and December 2019. Other analyses used Stata software (StataCorp. 2017. Stata Statistical Software: Release 15. College Station, TX: StataCorp LLC).43

Ethical Considerations

The information included in this report are routinely collected programmatic data and do not constitute human subject research. The University of Washington's Internal Review Board provided nonresearch determination for this routine program implementation analysis.

RESULTS

Characterization of Adverse Events

From April 2014 to December 2019, 469,000 men aged ≥10 years were circumcised in the ZAZIC MC program. Of the total MCs conducted, 38% (177,897/469,000) were conducted among individuals aged 10–14 years, 27% (126,026/469,000) among individuals aged 15–19 years, and 35% (164,987/469,000) among individuals ≥20 years. MC productivity increased over the study period with 134,589 MCs in 2019, alone. Across all years, ZAZIC reported 632 combined moderate or SAEs (0.13%). Of the 632 AEs, 621 (98.2%) had AE management information (Table 1): 365 (59%) moderate and 256 (41%) severe. Among all MCs, 0.08% and 0.05% resulted in moderate or SAEs, respectively. Of the 256 SAEs, 39% occurred among individuals aged ≥20, 37% were reported between days 3 and 7, 56% occurred after nurse-led MC, and 36% were due to device displacement among PrePex procedures. Of the 621 AEs, 594 (94%) had information on the MC method (dorsal slit method, forceps-guided method, or PrePex) (Table 2). Of the 594, 78% resulted from the surgical method: 345 (58%) from dorsal slit method and 117 (20%) from forceps-guided. The remaining 132 (22%) resulted from PrePex. Among the 345 dorsal slit AEs, 68% were moderate, 81% occurred among boys aged 10–14 years, 45% were reported between days 3 and 7, and 73% were infections. Among the 117 forceps-guided AEs, 68% were moderate, 54% occurred among those aged 15–19 years, 49% were reported between days 3 and 7, and 56% were infections. For the 132 PrePex AEs, 77% were severe, 66% were among men aged ≥20 years, and 45% were reported between days 3 and 7.

TABLE 1. - Characterization of AEs by Severity (n = 621)
Total % (n), N = 621 Moderate % (n), N = 365 Severe % (n), N = 256 P
Age category in yr <0.001
 10–14 49 (303) 58 (211) 36 (92)
 15–19 24 (152) 24 (88) 25 (64)
 20+ 27 (166) 18 (66) 39 (100)
Days to adverse event <0.001
 ≤Day 2 22 (138) 15 (56) 32 (82)
 Days 3–7 47 (289) 53 (195) 37 (94)
 Days 8–14 20 (126) 23 (84) 16 (42)
 Day 15+ 11 (68) 8 (30) 15 (38)
Facility site type <0.001
 Outreach 56 (345) 61 (223) 48 (122)
 Static 44 (276) 39 (142) 52 (134)
Method 0.004
 Forceps-guided 19 (117) 22 (79) 15 (38)
 Dorsal slit 56 (345) 64 (233) 44 (112)
 PrePex 21 (132) 8 (30) 40 (102)
 Missing 4 (27) 6 (23) 2 (4)
Cadre 0.006
 Nurse 65 (403) 59 (217) 56 (65)
 Doctor 31 (190) 34 (125) 44 (51)
 Missing 5 (28) 6 (23) 2 (5)
AE category <0.001
 BL 16 (101) 18 (67) 13 (34)
 DD 15 (94) 1 (2) 36 (92)
 IN 58 (361) 77 (281) 31 (80)
 OA 11 (65) 4 (15) 20 (50)
BL, bleeding; DD, device displacement; IN, infection; OA, other AEs (most typically swelling, but also includes problems with anesthesia, occupational exposure, and scarring/disfigurement/poor cosmetic result; insufficient skin removal; excess skin removal; penile torsion; injury to glans or shaft of penis; sexual dysfunction/undesirable sensory changes; hematoma; and difficulty in urinating).

Table 2. - Characterization of AEs by the Circumcision Method (n = 594)
Total Percent (n), N = 594 Dorsal Slit Percent (n), N = 345 Forceps-Guided Percent (n), N = 117 PrePex Percent (n), N = 132 P
Age category in years <0.001
 10–14 49% (292) 81% (280) 10% (12) 0% (0)
 15–19 24% (142) 10% (34) 54% (63) 34% (45)
 20+ 27% (160) 9% (31) 36% (42) 66% (87)
Days to AE <0.001
 ≤Day 2 22% (133) 16% (56) 26% (31) 35% (46)
 Days 3–7 46% (271) 45% (155) 49% (57) 45% (59)
 Days 8–14 21% (124) 25% (86) 19% (22) 12% (16)
 Day 15+ 11% (66) 14% (48) 6% (7) 8% (11)
Facility site type 0.072
 Outreach 55% (345) 61% (211) 64% (75) 30% (40)
 Static 45% (276) 39% (134) 36% (42) 70% (92)
Severity of AE <0.001
 Moderate 58% (342) 68% (233) 68% (79) 23% (30)
 Severe 42% (252) 32% (112) 32% (38) 77% (102)
Cadre <0.001
 Nurse 68% (401) 68% (234) 56% (65) 77% (102)
 Doctor 31% (182) 31% (108) 44% (51) 17% (23)
 Missing 2% (11) 1% (3) 1% (1) 5% (7)
AE type <0.001
 BL 16% (96) 16% (56) 30% (35) 4% (5)
 DD 16% (94) 0% (0) 0% (0) 71% (94)
 IN 57% (340) 73% (251) 56% (66) 17% (23)
 OA 11% (64) 11% (38) 14% (16) 8% (10)
BL, bleeding; DD, device displacement; IN, infection; OA, other AEs (most typically swelling, but also includes problems with anesthesia, occupational exposure, scarring/disfigurement/poor cosmetic result; insufficient skin removal; excess skin removal; penile torsion; injury to glans or shaft of penis; sexual dysfunction/undesirable sensory changes; hematoma; and difficulty in urinating).

Factors Associated With Experiencing Severe or Moderate AEs

Among clients with an AE, we explored factors associated with AE severity, moderate or severe (Table 3). In the adjusted model, younger clients aged 15–19 years {odds ratio (OR) 0.22 [95% confidence interval (CI): 0.13 to 0.36]} or 10–14 years [OR 0.37 (95% CI: 0.21 to 0.64)] had lower risk of a SAEs than older clients. Clients with AEs identified after day 2 had lower odds of a severe AE as compared to AEs identified earlier. Clients with PrePex were far more likely to have a severe versus moderate AE [OR 8.76 (95% CI: 5.07 to 15.13] as compared with clients of other MC methods. Although infections were the most common type of AE, clients with infections were less likely to have a SAE [OR 0.07 (CI: 0.05 to 0.13)]. There were no significant associations between individual characteristics and severity of infection.

Table 3. - Characteristics Associated With Experiencing a SAE
Unadjusted OR (95% CI) Adjusted OR (95% CI)*
Age category in year (n = 621)
 10–14 0.29 (0.19 to 0.43) 0.37 (0.21 to 0.64)
 15–19 0.48 (0.31 to 0.75) 0.22 (0.13 to 0.36)
 20+ Reference Reference
Time to AE (n = 621)
 ≤Day 2 Reference Reference
 Days 3–7 0.32 (0.22 to 0.50) 0.31 (0.19 to 0.51)
 Days 8–14 0.34 (0.21 to 0.56) 0.24 (0.26 to 0.44)
 Day 15+ 0.87 (0.48 to 1.56) 0.86 (0.44 to 1.69)
Type of medical MC (n = 594)
 Surgical Reference Reference
 PrePex 7.40 (4.72 to 11.59) 8.76 (5.07 to 15.13)
Facility site type (n = 621)
 Outreach Reference Reference
 Static 0.71 (0.69 to 1.33) 0.62 (0.38 to 1.00)
Type of AE (n = 621)
 Other Reference Reference
 Infection 0.13 (0.09 to 019) 0.07 (0.05 to 0.13)
*Adjusted for site and allowing for clustering.
For 27 AEs, the method of male MC was not recorded.
Others = bleeding, device displacement, swelling, problems with anesthesia, occupational exposure, and scarring/disfigurement/poor cosmetic result; insufficient skin removal; excess skin removal; penile torsion; injury to glans or shaft of penis; sexual dysfunction/undesirable sensory changes; hematoma; and difficulty in urinating.

Five-Year AE Trends by Year and Age

From 2015 to 2019, the total AE (moderate and severe) rate declined significantly from 34.24/10,000 (95% CI: 29.09 to 40.04) to 5.28/10,000 (95% CI: 4.12 to 6.65), respectively (Table 4). Over the same period, AEs rates were lower among men aged ≥20 {9.03/10,000 [95% CI: (7.60 to 10.65)] compared with clients aged 10–14 [18.00/10,000 (95% CI: 15.99 to 20.19)] and aged 15–19 years [12.51/10,000 (95% CI: 10.49 to 14.80)]}.

Table 4. - Five-year trends in AE and SAE rates per 10,000 MCs performed between 2015 and 2019
Total MC Total AE Rates per 10,000 (95% CI)* P* Total SAE Rates per 10,000 (95% CI)* P*
By year <0.001 <0.001
 2015 45,561 156 34.24 (29.09 to 40.04) 55 12.07 (9.10 to 15.71)
 2016 65,530 189 28.84 (24.88 to 33.25) 72 10.99 (8.60 to 13.84)
 2017 96,418 101 10.48 (8.53 to 12.73) 44 4.56 (3.32 to 6.13)
 2018 83,098 49 5.90 (4.36 to 7.80) 27 3.25 (2.14 to 4.73)
 2019 134,589 71 5.28 (4.12 to 6.65) 30 2.23 (1.50 to 3.18)
By age <0.001 0.682
 10–14 161,129 290 18.00 (15.99 to 20.19) 86 5.34 (4.27 to 6.59)
 15–19 107,955 135 12.51 (10.49 to 14.80) 63 5.83 (4.48 to 7.47)
 20+ 156,112 141 9.03 (7.60 to 10.65) 78 5.00 (3.95 to 6.24)
*P-value from the χ2 test for trend.
AE, adverse event (moderate and severe); MC, male circumcision.

Three-Year SAE Trends by Year, Age, and MC Method

SAE were rare across the study period. SAE rates declined significantly (P-value <0.001) from 12.07/10,000 in 2015 (95% CI: 9.10 to 15.71) to 2.23/10,000 in 2019 (95% CI: 1.50 to 3.18) (Table 5). SAE rates by the dorsal slit method declined significantly by year (P-value 0.001) and by age, with younger clients aged 10–14 having higher SAE rates {5.88 (95% CI: 4.55 to 7.48) than older clients ≥20 [1.12 (95% CI: 0.58 to 1.96)]} (P-value <0.001). SAE rates by the forceps-guided method did not decline significantly over the 3-year period (P-value 0.889). There was one SAE among the 51 younger clients aged 10–14 who underwent forceps-guided MC, for an AE rate of [196.1 (95% CI: 4.96 to 1044.75)]; this was higher (P-value 0.026) than the AE rate among older clients ≥20 [2.64 (95% CI: 0.97 to 5.74)].

Table 5. - Three-year trends in AE and SAE rates per 10,000 MCs performed between 2017 and 2019
Total MC Total AE Rates per 10,000 (95% CI)* P* Total SAE Rates per 10,000 (95% CI)* P*
By method 0.229 0.583
 Dorsal slit 280,529 194 6.92 (5.98, 7.96) 88 3.87 (2.06, 6.62)
 Forceps-guided 33,576 30 8.94 (6.03, 12.75) 13 3.14 (2.52, 3.87)
 Method: dorsal slit
By year <0.001 0.001
 2017 70,893 75 10.57 (8.32, 13.33) 32 4.51 (3.09, 6.37)
 2018 75,327 52 6.90 (5.16, 9.05) 29 3.85 (2.58, 5.53)
 2019 134,309 67 4.98 (3.87, 6.33) 27 2.01 (1.32, 2.93)
By age <0.001 <0.001
 10–14 115,357 139 0.0012 (0.0010, 0.0014) 66 5.88 (4.55, 7.48)
 15–19 58,384 26 0.0004 (0.0003, 0.0007) 10 1.71 (0.82, 3.15)
 20+ 106,788 29 0.0003 (0.0002, 0.0004) 12 1.12 (0.58, 1.96)
Method: forceps-guided
By year 0.07 0.889
 2017 25,520 28 10.97 (7.29, 15.85) 11 4.31 (2.15, 7.71)
 2018 7771 1 1.29 (0.03, 7.17) 1 1.29 (0.03, 7.17)
 2019 280 1 9.89 (0.9, 197.37) 1 35.71 (0.90, 197.37)
By age 0.2051 0.026
 10–14 51 1 0.02 (0.001, 0.104) 1 196.1 (4.96,1044.75)
 15–19 10,788 11 0.001 (0.001, 0.002) 6 5.56 (2.04, 12.10)
 20+ 22,737 18 0.001 (0.001, 0.001) 6 2.64 (0.97, 5.74)
*P-value from the χ2 test for trend.
Total MC data by the surgical method only available from 2017.
AE, adverse event (moderate and severe); MC, male circumcision; SAE, severe adverse event.

DISCUSSION

From April 2014 to December 2019, ZAZIC conducted 469,000 MCs across Zimbabwe with an overall AE rate of 0.13% (0.08% moderate AEs and 0.05 severe AEs). Between 2015 and 2019, the overall AE rates dropped significantly from 34.2/10,000 to 5.3/10,000. Between 2017 and 2019, SAE rates declined significantly across age groups for both the dorsal slit and forceps-guided MCs; the SAE decline over time was significant for dorsal slit MCs. Our findings are consistent with other large scale MC programs operating in the region,14 with similar AE rates and below the commonly accepted combined moderate and SAE rate of 2%, regarded as the global safety standard.44 Several findings warrant further consideration.

First, more than 75% AEs (102/130) among PrePex method MCs were severe. The high proportion of severe AEs among PrePex clients is because 71% (91/132) of all PrePex AEs were attributed to device displacement. According to PEPFAR AE guidance, device displacement is categorized as severe because management typically requires subsequent surgical circumcision.

Second, age was a factor in AE patterns. Although a ZAZIC study using 2014–2015 data found that younger clients aged 10–14 were not a greater risk of having an AE, they are at a greater risk of infection.10 Subsequent studies also confirmed that younger boys are most at risk of AEs,9,14,45,46 predominantly infections, and that these younger clients were most likely to suffer rare SAEs, including glans amputations34,35 or fistulas.47 To help minimize the risk of glans injuries of the youngest clients, revised guidance from the World Health Organization because of safety concerns and questions on young boys' maturity to independently consent to VMMC with its AE risks, in 2017, recommended dorsal slit procedure for younger boys aged 10–14.48 Subsequent 2019 guidance from PEPFAR guided by safety concerns in younger boys who had higher rates of AEs including fistula and glans amputation because of immature penile anatomy, restricted MC to 15 years of age and above,49 focusing on clients aged 15–29 whose anatomy and maturity made the MC procedure safer.

Third, decreasing AE rates may reflect increased client and guardian capacity for correct and consistent postoperative wound care. With widespread MC services, and near saturation in MC coverage across several districts,49 clients and caregivers may seek informal wound care advice from others who previously underwent MC in their communities, receiving help to improve wound care. Adolescents and their care givers may also be caring for wounds better because of ZAZIC's heightened attention to postoperative counseling and a tailored MC education approach specifically for adolescents, successfully used elsewhere in the region.50 ZAZIC's wound care materials targeting young boys and their caregivers include clear image-based instructions on wound management, increasing the likelihood of proper postoperative care. Among adults, men may prefer to heal at home, without routine follow-up, seeking health care advice for wound care without needing a clinical review. A recent study of SMS-based, postoperative follow-up instead of routine in-person reviews in Zimbabwe found that adult men were able to manage wounds and identify complications that required clinical review, leaving most men to heal without observation or complication.51 These interventions highlight early AE identification and proper wound care by both clients and caregivers which may have likely everted progression in severity.

This study has a number of limitations that should be considered when interpreting the results. First, complete data on total MC performed by method were unavailable for 2014–2016. Therefore, analysis of AEs rates by the MC method is restricted to 2017–2019, reducing our ability to determine the impact of MC policy change on MC method–specific AE rates. Second, AEs may be underreported because of poor documentation or clients seeking care outside of ZAZIC sites, attenuating overall AE rates. In addition, our analysis does not include AE reports from 9 of the 51 sites, a potential bias if experiences at these sites differed. Moreover, errors in AE severity classification could influence results in either direction as severe AEs are more likely to be reported, but severe AEs may also be documented as moderate to avoid additional reporting burden. The time of AE identification could be misclassified if clients noted complications but delayed care seeking. Finally, low rates of AEs may reflect underreporting of AEs because of the AE reporting burden, fear of repercussions, and provider confidence in managing AEs on their own.24,52 As ZAZIC continues to train more circumcisers, including more locum nurses, to expand MC service delivery, attention is needed to ensure new nurses are well trained in AE identification, documentation, and reporting.52 Despite these limitations, we believe the strengths of the findings warrant attention to inform MC programs and policies.

In conclusion, over the 5-year period, overall AE rates from the ZAZIC program remained lower than the World Health Organization acceptable minimum and showed a downward trend of AE rates over time. In addition to safety gains from increasing provider and program experience over time, we also attribute these consistent improvements to several ZAZIC quality assurance activities. First, ZAZIC's tandem reviews between expert clinicians and less-experienced site-based circumcisers provides one-on-one, on-the-job mentorship from MC procedures through client follow-up, helping encourage guideline adherence, accurate AE identification, and timely reporting.24 Furthermore, ZAZIC's MC training and refresher trainings are continuously updated and supported by mentoring visits, ensuring that providers are aware of new guidance and confident in applying new skills. ZAZIC's Quality Improvement Task Force conducts spot audits, data quality exercises, and tandem reviews focused on client follow-ups and AE ascertainment, helping improve AE reporting over time.53 Finally, the MoHCC created a VMMC mentorship program in 2018 to complement training efforts by teaming a group of urologists and general surgeons to VMMC providers in each province, providing accessible consult for severe or complex AE management. These quality assurance efforts, combined with consistent MoHCC partnership in quality service delivery, enabled ZAZIC to continually improve client safety standards while providing quality MC services at scale.

ACKNOWLEDGMENTS

The authors thank the Zimbabwe Ministry of Health and Child Care and the MC teams from its districts for their dedication to MC program quality and client safety.

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Keywords:

male circumcision; adverse events; HIV prevention; quality of care; program evaluation

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.