Understanding Ethical, Legal and Societal Issues (ELSIs) in Human Biobanking and Genomics for Research and Healthcare in Zimbabwe: The Genomics Inheritance Law Ethics and Society (GILES) initiative.

Biobanks and human genomics applications are key for understanding health, disease and heredity in Africa and globally. Growing interest in these technologies calls for strengthening relevant legal, ethical and policy systems to address knowledge disparities and ensure protection of society, while supporting advancement of science. In Zimbabwe there is limited understanding of ethical, legal, and societal issues (ELSI) for biobanking and genomics. The Genomics Inheritance Law Ethics and Society (GILES) initiative was established in 2015 to explore the current status and gaps in the ethical and legal frameworks, knowledge among various stakeholders, and to establish capacity for addressing ELSI of biobanking and genomics as applied in biomedical and population research, and healthcare. A multi-methods approach was applied including document reviews, focus group discussions and in-depth interviews among health and research professionals, and community members in six provinces comprising urban, peri-urban and rural areas. Emerging findings indicates a need for updating guidelines and policies for addressing ELSI in biobanking and genomics research in Zimbabwe. Emerging terminologies such as biobanking and genomics lack clarity suggesting a need for increased awareness and educational tools for health professionals, research scientists and community members. Common concerns relating to consent processes, sample and data use and sharing, particularly where there is trans-national flow of biospecimens and data, call for nationally tailored ELSI frameworks aligned to regional and international initiatives. This paper describes the strategy undertaken for the development and implementation of the GILES project and discusses the importance of such an initiative for characterisation of ELSI of human biobanking and genomics in Zimbabwe and Africa. Conducting this explorative study among a wide range of stakeholders over a countrywide geographical regions, established one of the most comprehensive studies for ELSI of human biobanking and genomics in Africa.

The Brain Drain Myth: Retention of Specialist Surgical Graduates in East, Central and Southern Africa, 1974-2013.

BACKGROUND: This study assesses the retention of specialist surgical graduates from training programmes across eight countries in East, Central and Southern Africa from 1974 to 2013. It addresses the gap in existing data by analysing retention rates of surgical graduates by comparing graduating institution to current location. Data were assessed by country, region, specialty and gender with a view to informing national and regional healthcare and education strategies. METHODS: Twenty-five institutions train surgeons in the ten countries covered by the College of Surgeons of East, Central and Southern Africa (COSECSA)-24 Universities and the College itself. These institutions were requested in November 2014 to supply details of graduates from their postgraduate surgical training programmes. Complete graduate lists were returned by the College and 14 universities by March 2016. These surgical graduates were compared against the database of current practising surgeons in the region held by COSECSA. Data were cross-checked against medical council registers, surgical society records, and with members and fellows of COSECSA. RESULTS: Data were incomplete for 126 surgical graduates. Of the remaining 1038 surgical graduates, 85.1% were retained in the country they trained in, while 88.3% were retained within the COSECSA region. Ninety-three per cent (93.4%) were retained within Africa. Of the eight countries, Malawi had the highest retention rate with 100% of surgical graduates remaining in country, while Zimbabwe had the lowest rate with 65.5% remaining. CONCLUSION: High surgical graduate retention rates across the region indicate that the expansion of national surgical training initiatives is an effective solution to addressing the surgical workforce shortage in East, Central and Southern Africa and counters long-held arguments regarding brain drain in this region.

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.

Safety Profile of PrePex Male Circumcision Device and Client Satisfaction With Adolescent Males Aged 13-17 Years in Zimbabwe.

BACKGROUND: The safety and efficacy of the PrePex device for voluntary medical male circumcision (VMMC) has been demonstrated in studies in Rwanda, Uganda, and Zimbabwe, leading to the conditional prequalification of the device for use in adults. Because the majority of VMMC clients in the 14 priority countries are adolescents under 18 years, research to establish the safety and efficacy of the device for males <18 years is required. METHODS: One-arm, prospective study included 402 adolescents, aged 13-17 years, using PrePex device between August 2013 and January 2014 at a VMMC centre in Harare. Endpoints are number and grade of adverse events associated with device circumcision, time to complete wound healing, client satisfaction with the procedure, and outcome. RESULTS: The rate of medical ineligibility among adolescent males was high; 237/402 (35.9%) of study participants had to be excluded based on medical reasons. The severe/moderate adverse event rate was low at 2/402 (0.5%). No device displacements/self-removals were observed. Time to complete wound healing was shorter than in adults; 367/398 (92.2%) adolescents had completed wound healing by day 35, whereas 90% of adults had completed wound healing by day 56 as demonstrated in previous studies. Overall, adolescents were highly satisfied with the results of their circumcision. CONCLUSIONS: The study demonstrates that the PrePex device can be safely used in adolescents aged 13-17 years. The significant proportion of males opting for surgical circumcision and the high medical ineligibility suggest that surgical circumcision needs to be provided alongside PrePex services in programs targeting young age groups.

Safety and Acceptability of the PrePex Device When Used in Routine Male Circumcision Service Delivery During Active Surveillance in Zimbabwe.

BACKGROUND: Male circumcision devices have the potential to accelerate voluntary medical male circumcision roll-out, with PrePex being one promising device. Here, we present findings on safety and acceptability from active surveillance of the implementation of PrePex among 1000 males circumcised in Zimbabwe. METHODS: The first 1000 men consecutively circumcised using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for postcircumcision visits, and adverse events (AEs). A survey was conducted among 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. RESULTS: A total of 2156 men aged 18 years or older were circumcised across the 6 PrePex active surveillance sites. Of these, 1000 (46.4%) were circumcised using PrePex. Among them, 4 (0.4%) self-removals that required surgery (severe AEs) were observed. Six (0.6%) removals by providers (moderate AEs) did not require surgery. A further 280 (28%) AEs were mild or moderate pain during device removal. There were also 12 (1.2%) moderate AEs unrelated to pain. All AEs resolved without sequelae. There was high adherence to follow-up appointments, with 97.7% of clients attending the scheduled day 7 visit. Acceptability of PrePex was high among survey participants, 93% indicated willingness to recommend the device to peers. Of note, 95.8% of respondents reported experiencing pain when the device was being removed. Additionally, 85.2% reported experiencing odor while wearing the device or during removal. CONCLUSIONS: Active surveillance of the first 1000 men circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery.

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.

Quality of voluntary medical male circumcision services during scale-up: a comparative process evaluation in Kenya, South Africa, Tanzania and Zimbabwe.

BACKGROUND: The rapid expansion of voluntary medical male circumcision (VMMC) has raised concerns whether health systems can deliver and sustain VMMC according to minimum quality criteria. METHODS AND FINDINGS: A comparative process evaluation was used to examine data from SYMMACS, the Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-Up, among health facilities providing VMMC across two years of program scale-up. Site-level assessments examined the availability of guidelines, supplies and equipment, infection control, and continuity of care services. Direct observation of VMMC surgeries were used to assess care quality. Two sample tests of proportions and t-tests were used to examine differences in the percent of facilities meeting requisite preparedness standards and the mean number of directly-observed surgical tasks performed correctly. Results showed that safe, high quality VMMC can be implemented and sustained at-scale, although substantial variability was observed over time. In some settings, facility preparedness and VMMC service quality improved as the number of VMMC facilities increased. Yet, lapses in high performance and expansion of considerably deficient services were also observed. Surgical tasks had the highest quality scores, with lower performance levels in infection control, pre-operative examinations, and post-operative patient monitoring and counseling. The range of scale-up models used across countries additionally underscored the complexity of delivering high quality VMMC. CONCLUSIONS: Greater efforts are needed to integrate VMMC scale-up and quality improvement processes in sub-Saharan African settings. Monitoring of service quality, not just adverse events reporting, will be essential in realizing the full health impact of VMMC for HIV prevention.

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

INTRODUCTION: 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). METHODS: 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. CONCLUSIONS: 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.

Guidelines for surgeons on establishing projects in low-income countries.

BACKGROUND: There is increasing interest by surgeons in high-income countries to support colleagues in low-income countries to improve the provision of surgical care, particularly in rural areas. Such interest may be demonstrated by single individuals, short-term surgical missions, or establishment of partnerships. Such altruistic efforts may cause problems unless properly planned and carried out. METHODS: We reviewed the available literature and consulted widely to establish consensus guidelines for any surgeon considering participating in an initiative to improve surgical care in low-income countries. RESULTS: A series of recommendations is presented. These include ensuring that projects are appropriate, that there is an emphasis on training local healthcare providers in all aspects of perioperative care, that outcomes are monitored, and that initiatives work with local and regional training programs. CONCLUSIONS: With adherence to these recommendations, we hope that future partnerships and missions can maximize their effectiveness and minimize the risks of potential harm done.

Challenges in training the ideal Doctor for Africa: lessons learned from Zimbabwe.

BACKGROUND: Limited competencies among doctors and reduced numbers from medical migration in Africa could be corrected through innovative curricula and retention of trained manpower. The University of Zimbabwe Medical School simultaneously decided to increase the quality and quantity of doctors to address shortages. AIMS: To evaluate the outcome of innovative medical education at the University of Zimbabwe Medical School. METHOD: A structured questionnaire was administered to a broad group of staff and student representatives. In addition, a desk review of academic documents and policies and procedures was carried out. RESULTS: Early patient contact and community attachment which were introduced to the traditional curriculum remained but other teaching methodologies were not sustained with traditional didactic training still taking centre stage with limited staff development and retention. Whilst the annual student enrolment increased from less than 80 to 200 per year the vacancy rate of academic staff increased to 50%. CONCLUSION: Innovative curricula were partially implemented. The annual student intake increased but the staff complement declined. There is an urgent need to monitor and evaluate outcomes of medical education in Africa to arrest further decline in the quality of health care services.