Implementation and Operational Research: A Randomized Noninferiority Trial of AccuCirc Device Versus Mogen Clamp for Early Infant Male Circumcision in Zimbabwe.

BACKGROUND: Early infant male circumcision (EIMC) is a potential key HIV prevention intervention, providing it can be safely and efficiently implemented in sub-Saharan Africa. Here, we present results of a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe. METHODS: Between January and June 2013, eligible infants were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor, using a 2:1 allocation ratio. Participants were followed for 14 days post-EIMC. Primary outcomes for the trial were EIMC safety and acceptability. RESULTS: One hundred fifty male infants were enrolled in the trial and circumcised between 6 and 54 days postpartum (n = 100 AccuCirc; n = 50 Mogen clamp). Twenty-six infants (17%) were born to HIV-infected mothers. We observed 2 moderate adverse events (AEs) [2%, 95% confidence interval (CI): 0.2 to 7.0] in the AccuCirc arm and none (95% CI: 0.0 to 7.1) in the Mogen clamp arm. The cumulative incident risk of AEs was 2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 to 4.7). As the 95% CI excludes the predefined noninferiority margin of 6%, the result provides evidence of noninferiority of AccuCirc compared with the Mogen clamp. Nearly all mothers (99.5%) reported great satisfaction with the outcome. All mothers, regardless of arm said they would recommend EIMC to other parents, and would circumcise their next son. CONCLUSIONS: This first randomized trial of AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices is safe and acceptable to parents. There was no difference in the rate of AEs by device

Safety, Acceptability, and Feasibility of Early Infant Male Circumcision Conducted by Nurse-Midwives Using the AccuCirc Device: Results of a Field Study in Zimbabwe.

BACKGROUND: For prevention of HIV, early infant male circumcision (EIMC) needs to be scaled up in countries with high HIV prevalence. Routine EIMC will maintain the HIV prevention gains anticipated from current adult male circumcision initiatives. We present here the results of a field study of EIMC conducted in Zimbabwe. METHODS: The study was observational and based on the World Health Organization (WHO) framework for clinical evaluation of male circumcision devices. We recruited parents of newborn male infants between August 2013 and July 2014 from 2 clinics. Nurse-midwives used the AccuCirc device to circumcise eligible infants. We followed participants for 14 days after EIMC. Outcome measures were EIMC safety, acceptability, and feasibility. RESULTS: We enrolled 500 male infants in the field study (uptake 11%). The infants were circumcised between 6 and 60 days postpartum. The procedure took a median of 17 minutes (interquartile range of 5 to 18 minutes). Mothers' knowledge of male circumcision was extensive. Of the 498 mothers who completed the study questionnaire, 91% knew that male circumcision decreases the risk of HIV acquisition, and 83% correctly stated that this prevention is partial. Asked about their community's perception of EIMC, 40% felt that EIMC will likely be viewed positively in their community; 13% said negatively; and 47% said the perception could be both ways. We observed 7 moderate or severe adverse events (1.4%; 95% confidence interval, 0.4% to 2.4%). All resolved without lasting effects. Nearly all mothers (99%) reported great satisfaction with the outcome, would recommend EIMC to other parents, and would circumcise their next sons. CONCLUSION: This first field study in sub-Saharan Africa of the AccuCirc device for EIMC demonstrated that EIMC conducted by nurse-midwives with this device is safe, feasible, and acceptable to parents

Lessons learned during establishment of the college of health sciences of the University of Zimbabwe 1995-2001

Background: The five year training of medical doctors has been conducted through the Faculty of Medicine of the University of Zimbabwe since 1963 in two physical sites in Harare; Mount Pleasant Campus for Basic Sciences and Mazowe Street Campus for Clinical Sciences. Annual student enrolment has gradually increased from less than 30 in the early stages to 200 currently. The continuing brain drain of doctors from the country necessitated the Government to instruct the Faculty of Medicine to double its student intake by enrolling a new student intake within three months to address this shortage. Methods: This descriptive longitudinal study is largely complemented by desk review and reflections from the authors who oversaw the evolution of the Faculty into the College. Authors experienced the transition of the institution over most of the study period and shared first-hand information. Results: Instruction from Government was used as an opportunity to develop. The Faculty of Medicine developed and began implementation of its inaugural five year strategic plan 1995-2001. The key tenets of the plan were to be a semi-autonomous institution (in relation to the University of Zimbabwe) comprising five Faculties with a designated teaching hospital under joint administration with Government where academicians were to receive similar emoluments. Clinicians were entitled to additional remuneration from Government for the clinical work delivered. The infrastructure was expanded to accommodate 200 medical students annually at the two sites. A government loan secured from the Spanish Protocol was used to purpose build the Health Sciences Building and equipment to accommodate and equip the five faculties. Discussion: The directive by Government to double medical student intake in order to address the doctor shortages was used as opportunity to address some of the Faculty of Medicine’s academic needs, including infrastructure, professional development and additional academic provisions in line with international trends. The realization of some of the outcomes is on course with the exception of ownership of a teaching hospital, autonomy of the College from the University and additional emoluments for clinicians from government, which are work in progress

Surgical efficiencies and quality in the performance of voluntary medical male circumcision (VMMC) procedures in Kenya, South Africa, Tanzania, and Zimbabwe.

This analysis explores the association between elements of surgical efficiency in voluntary medical male circumcision (VMMC), quality of surgical technique, and the amount of time required to conduct VMMC procedures in actual field settings. Efficiency outcomes are defined in terms of the primary provider's time with the client (PPTC) and total elapsed operating time (TEOT).Two serial cross-sectional surveys of VMMC sites were conducted in Kenya, Republic of South Africa, Tanzania and Zimbabwe in 2011 and 2012. Trained clinicians observed quality of surgical technique and timed 9 steps in the VMMC procedure. Four elements of efficiency (task-shifting, task-sharing [of suturing], rotation among multiple surgical beds, and use of electrocautery) and quality of surgical technique were assessed as explanatory variables. Mann Whitney and Kruskal Wallis tests were used in the bivariate analysis and linear regression models for the multivariate analyses to test the relationship between these five explanatory variables and two outcomes: PPTC and TEOT. The VMMC procedure TEOT and PPTC averaged 23-25 minutes and 6-15 minutes, respectively, across the four countries and two years. The data showed time savings from task-sharing in suturing and use of electrocautery in South Africa and Zimbabwe (where task-shifting is not authorized). After adjusting for confounders, results demonstrated that having a secondary provider complete suturing and use of electrocautery reduced PPTC. Factors related to TEOT varied by country and year, but task-sharing of suturing and/or electrocautery were significant in two countries. Quality of surgical technique was not significantly related to PPTC or TEOT, except for South Africa in 2012 where higher quality was associated with lower TEOT.SYMMACS data confirm the efficiency benefits of task-sharing of suturing and use of electrocautery for decreasing TEOT. Reduced TEOT and PPTC in high volume setting did not result in decreased quality of surgical care

Median TEOT and PPTC (in minutes:seconds) for the VMMC procedure, by elements of interest and by country<b>.</b>

<p>* = p-value under 0.10 significance;</p><p>** = p-value under 0.05 significance; τ = cells with less than five observations were excluded from this analysis.</p

Descriptive statistics on four surgical efficiency elements and the quality score for VMMC procedures, by year and by country<b>.</b>

<p>Descriptive statistics on four surgical efficiency elements and the quality score for VMMC procedures, by year and by country<b>.</b></p

Regressions by year and by country, to predict primary provider time with client (PPTC) in seconds.

<p>* = p<0.10;</p><p>** = p<0.05; τ = cells with less than five observations were excluded from this analysis.</p

Regressions by year and by country to predict total elapsed operating time (TEOP) in seconds.

<p>* = p-value under 0.10 significance;</p><p>** = p-value under 0.05 significance; τ = cells with less than five observations were excluded from this analysis.</p

Item-Level Quality of VMMC Surgical Care from Initial Year (2011) to Expansion Year (2012).

[A]<p>Includes only percent of surgical observations with total score ( = 1 point). Items receiving a partial score ( = 0.5 point) during observation were not counted as correctly done.</p>*<p>Differences from T₀ to T₁ reported at p<0.05 statistical significance.</p