The development of task sharing policy and guidelines in Kenya.

BACKGROUND: The global critical shortage of health workers prevents expansion of healthcare services and universal health coverage. Like most countries in sub-Saharan Africa, Kenya's healthcare workforce density of 13.8 health workers per 10,000 population falls below the World Health Organization (WHO) recommendation of at least 44.5 doctors, nurses, and midwives per 10,000 population. In response to the health worker shortage, the WHO recommends task sharing, a strategy that can increase access to quality health services. To improve the utilization of human and financial health resources in Kenya for HIV and other essential health services, the Kenya Ministry of Health (MOH) in collaboration with various institutions developed national task sharing policy and guidelines (TSP). To advance task sharing, this article describes the process of developing, adopting, and implementing the Kenya TSP. CASE PRESENTATION: The development and approval of Kenya's TSP occurred from February 2015 to May 2017. The U.S. Centers for Disease Control and Prevention (CDC) allocated funding to Emory University through the United States President's Emergency Plan for AIDS Relief (PEPFAR) Advancing Children's Treatment initiative. After obtaining support from leadership in Kenya's MOH and health professional institutions, the TSP team conducted a desk review of policies, guidelines, scopes of practice, task analyses, grey literature, and peer-reviewed research. Subsequently, a Policy Advisory Committee was established to guide the process and worked collaboratively to form technical working groups that arrived at consensus and drafted the policy. The collaborative, multidisciplinary process led to the identification of gaps in service delivery resulting from health workforce shortages. This facilitated the development of the Kenya TSP, which provides a general orientation of task sharing in Kenya. The guidelines list priority tasks for sharing by various cadres as informed by evidence, such as HIV testing and counseling tasks. The TSP documents were disseminated to all county healthcare facilities in Kenya, yet implementation was stopped by order of the judiciary in 2019 after a legal challenge from an association of medical laboratorians. CONCLUSIONS: Task sharing may increase access to healthcare services in resource-limited settings. To advance task sharing, TSP and clinical practice could be harmonized, and necessary adjustments made to other policies that regulate practice (e.g., scopes of practice). Revisions to pre-service training curricula could be conducted to ensure health professionals have the requisite competencies to perform shared tasks. Monitoring and evaluation can help ensure that task sharing is implemented appropriately to ensure quality outcomes.

Legal and institutional foundations for universal health coverage, Kenya.

Kenya's Constitution of 2010 triggered a cascade of reforms across all sectors to align with new constitutional standards, including devolution and a comprehensive bill of rights. The constitution acts as a platform to advance health rights and to restructure policy, legal, institutional and regulatory frameworks towards reversing chronic gaps and improving health outcomes. These constitutionally mandated health reforms are complex. All parts of the health system are transforming concurrently, with several new laws enacted and public health bodies established. Implementing such complex change was hampered by inadequate tools and approaches. To gain a picture of the extent of the health reforms over the first 10 years of the constitution, we developed an adapted health-system framework, guided by World Health Organization concepts and definitions. We applied the framework to document the health laws and public bodies already enacted and currently in progress, and compared the extent of transformation before and after the 2010 Constitution. Our analysis revealed multiple structures (laws and implementing public bodies) formed across the health system, with many new stewardship structures aligned to devolution, but with fragmentation within the regulation sub-function. By deconstructing normative health-system functions, the framework enabled an all-inclusive mapping of various health-system attributes (functions, laws and implementing bodies). We believe our framework is a useful tool for countries who wish to develop and implement a conducive legal foundation for universal health coverage. Constitutional reform is a mobilizing force for large leaps in health institutional change, boosting two aspects of feasibility for change: stakeholder acceptance and authority to proceed.

Adoptée en 2010, la Constitution du Kenya a entraîné une série de réformes dans tous les secteurs afin de les adapter aux nouvelles normes constitutionnelles, notamment à la décentralisation et à une charte détaillée des droits. La Constitution sert de tremplin pour faire progresser les droits en matière de santé et restructurer les cadres politiques, juridiques, institutionnels et réglementaires en vue de réduire les disparités chroniques et d'améliorer les résultats cliniques. Toutefois, ces réformes de santé prévues dans la Constitution sont complexes. Toutes les composantes du système de santé évoluent en même temps, de nombreuses lois inédites sont promulguées et des organismes de santé publique sont créés. L'emploi d'approches et d'outils inadaptés a entravé la mise en œuvre de ces changements si complexes. Pour mieux appréhender l'étendue des réformes de santé entreprises au cours des 10 premières années de la Constitution, nous avons développé un cadre sanitaire sur mesure, inspiré des concepts et définitions de l'Organisation mondiale de la Santé. Nous avons appliqué ce cadre afin de récolter des données sur les organismes publics et les lois relatives à la santé qui ont d'ores et déjà été édictées ou sont en cours d'élaboration, et avons comparé l'ampleur des transformations avant et après la Constitution de 2010. Notre analyse a révélé de multiples structures (lois et organes publics de mise en œuvre) réparties dans l'ensemble du système de santé, avec plusieurs nouvelles structures de gestion conformes à la décentralisation mais une fragmentation au niveau de la sous-fonction de régulation. En décomposant les fonctions normatives du système de santé, le cadre a permis d'établir une cartographie globale des différentes caractéristiques de ce système (fonctions, lois et organes de mise en œuvre). Nous sommes convaincus que notre cadre représente un outil utile pour les pays qui souhaitent développer et instaurer des bases juridiques propices à la création d'une couverture maladie universelle. La réforme constitutionnelle possède un pouvoir de mobilisation capable de faire progresser le changement institutionnel dans le domaine de la santé. Et ce, en renforçant deux aspects qui favorisent sa réalisation: l'acceptation de la part des intervenants, et l'autorité nécessaire pour agir.

La Constitución de Kenia de 2010 generó una serie de reformas en todos los sectores para ajustarse a los nuevos estándares constitucionales, incluida la transmisión y una amplia carta de derechos. La constitución representa una plataforma para promover los derechos sobre la salud y reestructurar los marcos jurídicos, institucionales y normativos con el fin de revertir las deficiencias crónicas y mejorar los resultados de la salud. Estas reformas de la salud, establecidas por mandato constitucional, son complejas. Asimismo, todas las áreas del sistema de salud se están transformando de manera simultánea, ya que se han promulgado varias leyes nuevas y se han establecido organismos de salud pública. Sin embargo, la falta de herramientas y métodos adecuados limitó la implementación de estos cambios tan complejos. Se elaboró un marco adaptado del sistema sanitario, que se guía por los conceptos y las definiciones de la Organización Mundial de la Salud, para tener una idea del alcance de las reformas sanitarias en los primeros 10 años de la constitución. En este contexto, se aplicó el marco para documentar las leyes sanitarias y los organismos públicos ya promulgados y en curso, en el que se comparó el grado de transformación antes y después de la Constitución de 2010. El análisis realizado reveló que se habían formado múltiples estructuras (leyes y organismos públicos de ejecución) en todo el sistema sanitario, que tenían muchas estructuras de gestión nuevas alineadas con la transmisión, pero que estaban fragmentadas dentro de la subfunción de reglamentación. Al desestructurar las funciones normativas del sistema sanitario, el marco permitió realizar un mapeo completo de los diversos atributos del sistema sanitario (funciones, leyes y organismos de ejecución). Se considera que el marco que se propone aquí es un instrumento útil para los países que quieren elaborar e implementar un fundamento jurídico propicio para la cobertura sanitaria universal. La reforma constitucional es una fuerza de movilización que permite obtener importantes avances en el cambio institucional del sector sanitario, lo que fomenta dos aspectos de la viabilidad del cambio: la aceptación de las partes interesadas y la autoridad para proceder.

Systems, supplies, and staff: a mixed-methods study of health care workers' experiences and health facility preparedness during a large national cholera outbreak, Kenya 2015.

BACKGROUND: From December 2014 to September 2016, a cholera outbreak in Kenya, the largest since 2010, caused 16,840 reported cases and 256 deaths. The outbreak affected 30 of Kenya's 47 counties and occurred shortly after the decentralization of many healthcare services to the county level. This mixed-methods study, conducted June-July 2015, assessed cholera preparedness in Homa Bay, Nairobi, and Mombasa counties and explored clinic- and community-based health care workers' (HCW) experiences during outbreak response. METHODS: Counties were selected based on cumulative cholera burden and geographic characteristics. We conducted 44 health facility cholera preparedness checklists (according to national guidelines) and 8 focus group discussions (FGDs). Frequencies from preparedness checklists were generated. To determine key themes from FGDs, inductive and deductive codes were applied; MAX software for qualitative data analysis (MAXQDA) was used to identify patterns. RESULTS: Some facilities lacked key materials for treating cholera patients, diagnosing cases, and maintaining infection control. Overall, 82% (36/44) of health facilities had oral rehydration salts, 65% (28/43) had IV fluids, 27% (12/44) had rectal swabs, 11% (5/44) had Cary-Blair transport media, and 86% (38/44) had gloves. A considerable number of facilities lacked disease reporting forms (34%, 14/41) and cholera treatment guidelines (37%, 16/43). In FDGs, HCWs described confusion regarding roles and reporting during the outbreak, which highlighted issues in coordination and management structures within the health system. Similar to checklist findings, FGD participants described supply challenges affecting laboratory preparedness and infection prevention and control. Perceived successes included community engagement, health education, strong collaboration between clinic and community HCWs, and HCWs' personal passion to help others. CONCLUSIONS: The confusion over roles, reporting, and management found in this evaluation highlights a need to adapt, implement, and communicate health strategies at the county level, in order to inform and train HCWs during health system transformations. International, national, and county stakeholders could strengthen preparedness and response for cholera and other public health emergencies in Kenya, and thereby strengthen global health security, through further investment in the existing Integrated Disease Surveillance and Response structure and national cholera prevention and control plan, and the adoption of county-specific cholera control plans.

Notes from the Field: Ongoing Cholera Outbreak - Kenya, 2014-2016.

On January 6, 2015, a man aged 40 years was admitted to Kenyatta National Hospital in Nairobi, Kenya, with acute watery diarrhea. The patient was found to be infected with toxigenic Vibrio cholerae serogroup O1, serotype Inaba. A subsequent review of surveillance reports identified four patients in Nairobi County during the preceding month who met either of the Kenya Ministry of Health suspected cholera case definitions: 1) severe dehydration or death from acute watery diarrhea (more than four episodes in 12 hours) in a patient aged ≥5 years, or 2) acute watery diarrhea in a patient aged ≥2 years in an area where there was an outbreak of cholera. An outbreak investigation was immediately initiated. A confirmed cholera case was defined as isolation of V. cholerae O1 or O139 from the stool of a patient with suspected cholera or a suspected cholera case that was epidemiologically linked to a confirmed case. By January 15, 2016, a total of 11,033 suspected or confirmed cases had been reported from 22 of Kenya's 47 counties (Table). The outbreak is ongoing.

The movement of multidrug-resistant tuberculosis across borders in East Africa needs a regional and global solution.

Kevin Cain and colleagues reflect on the cross border movement of people from Somalia with MDR-TB and the implications for MDR-TB programs in East Africa.

A protracted cholera outbreak among residents in an urban setting, Nairobi county, Kenya, 2015.

INTRODUCTION: in 2015, a cholera outbreak was confirmed in Nairobi county, Kenya, which we investigated to identify risk factors for infection and recommend control measures. METHODS: we analyzed national cholera surveillance data to describe epidemiological patterns and carried out a case-control study to find reasons for the Nairobi county outbreak. Suspected cholera cases were Nairobi residents aged >2 years with acute watery diarrhea (>4 stools/≤12 hours) and illness onset 1-14 May 2015. Confirmed cases had Vibrio cholerae isolated from stool. Case-patients were frequency-matched to persons without diarrhea (1:2 by age group, residence), interviewed using standardized questionaires. Logistic regression identified factors associated with case status. Household water was analyzed for fecal coliforms and Escherichia coli. RESULTS: during December 2014-June 2015, 4,218 cholera cases including 282 (6.7%) confirmed cases and 79 deaths (case-fatality rate [CFR] 1.9%) were reported from 14 of 47 Kenyan counties. Nairobi county reported 781 (19.0 %) cases (attack rate, 18/100,000 persons), including 607 (78%) hospitalisations, 20 deaths (CFR 2.6%) and 55 laboratory-confirmed cases (7.0%). Seven (70%) of 10 water samples from communal water points had coliforms; one had Escherichia coli. Factors associated with cholera in Nairobi were drinking untreated water (adjusted odds ratio [aOR] 6.5, 95% confidence interval [CI] 2.3-18.8), lacking health education (aOR 2.4, CI 1.1-7.9) and eating food outside home (aOR 2.4, 95% CI 1.2-5.7). CONCLUSION: we recommend safe water, health education, avoiding eating foods prepared outside home and improved sanitation in Nairobi county. Adherence to these practices could have prevented this protacted cholera outbreak.

Environmental Assessment and Blood Lead Levels of Children in Owino Uhuru and Bangladesh Settlements in Kenya.

BACKGROUND: Lead exposure is linked to intellectual disability and anemia in children. The United States Centers for Disease Control and Prevention (CDC) recommends biomonitoring of blood lead levels (BLLs) in children with BLL ≥5 µg/dL and chelation therapy for those with BLL ≥45 µg/dL. OBJECTIVES: This study aimed to determine blood and environmental lead levels and risk factors associated with elevated BLL among children from Owino Uhuru and Bangladesh settlements in Mombasa County, Kenya. METHODS: The present study is a population-based, cross-sectional study of children aged 12-59 months randomly selected from households in two neighboring settlements, Owino Uhuru, which has a lead smelter, and Bangladesh settlement (no smelter). Structured questionnaires were administered to parents and 1-3 ml venous blood drawn from each child was tested for lead using a LeadCare ® II portable analyzer. Environmental samples collected from half of the sampled households were tested for lead using graphite furnace atomic absorption spectroscopy. RESULTS: We enrolled 130 children, 65 from each settlement. Fifty-nine (45%) were males and the median age was 39 months (interquartile range (IQR): 30-52 months). BLLs ranged from 1 µg/dL to 31 µg/dL, with 45 (69%) children from Owino Uhuru and 18 (28%) children from Bangladesh settlement with BLLs >5 µg/dL. For Owino Uhuru, the geometric mean BLL in children was 7.4 µg/dL (geometric standard deviation (GSD); 1.9) compared to 3.7 µg/dL (GSD: 1.9) in Bangladesh settlement (p<0.05). The geometric mean lead concentration of soil samples from Owino Uhuru was 146.5 mg/Kg (GSD: 5.2) and 11.5 mg/Kg (GSD: 3.9) (p<0.001) in Bangladesh settlement. Children who resided <200 m from the lead smelter were more likely to have a BLL ≥5 µg/dL than children residing ≥200 m from the lead smelter (adjusted odds ratio (aOR): 33.6 (95% confidence interval (CI): 7.4-153.3). Males were also more likely than females to have a BLL ≥5 µg/dL (39, 62%) compared to a BLL<5 µg/dL [aOR: 2.4 (95% CI: 1.0-5.5)]. CONCLUSIONS: Children in Owino Uhuru had significantly higher BLLs compared with children in Bangladesh settlement. Interventions to diminish continued exposure to lead in the settlement should be undertaken. Continued monitoring of levels in children with detectable levels can evaluate whether interventions to reduce exposure are effective. PARTICIPANT CONSENT: Obtained. ETHICS APPROVAL: Scientific approval for the study was obtained from the Ministry of Health, lead poisoning technical working group. Since this investigation was considered a public health response of immediate concern, expedited ethical approval was obtained from the Kenya Medical Research Institute and further approval from the Mombasa County Department of Health Services. The investigation was considered a non-research public health response activity by the CDC. COMPETING INTERESTS: The authors declare no competing financial interests.

Factors associated with cholera in Kenya, 2008-2013.

INTRODUCTION: Kenya experienced widespread cholera outbreaks in 1997-1999 and 2007-2010. The re-emergence of cholera in Kenya in 2015 indicates that cholera remains a public health threat. Understanding past outbreaks is important for preventing future outbreaks. This study investigated the relationship between cholera occurrence in Kenya and various environmental and demographic factors related to water, sanitation, socio-economic status, education, urbanization and availability of health facilities during the time period 2008-2013. METHODS: The primary outcome analyzed was the number of cholera cases at the district level, obtained from the Kenya Ministry of Health's national cholera surveillance records. Values of independent variables were obtained from the 2009 Kenya Population and Housing Census and other national surveys. The data were analyzed using a zero-inflated negative binomial regression model. RESULTS: Multivariate analysis indicated that the risk of cholera was associated with open defecation, use of unimproved water sources, poverty headcount ratio and the number of health facilities per 100,000 population (p < 0.05). No statistically significant association was found between cholera occurrence and education, percentage of population living in urban areas or population density. CONCLUSION: The Sustainable Development Goals and Kenya's blueprint for development, Kenya Vision 2030, call for access to sanitation facilities and clean water for all by 2030. Kenya has made important economic strides in recent years but continues to be affected by diseases like cholera that are associated with low socio-economic status. Further expansion of access to sanitation facilities and clean water is necessary for preventing cholera in Kenya.

Strengthening health systems in Africa: a case study of the Kenya field epidemiology training program for local frontline health workers.

The logistical and operational challenges to improve public health practice capacity across Africa are well documented. This report describes Kenya's Field Epidemiology and Laboratory Training Program's (KFELTP) experience in implementing frontline public health worker training to transfer knowledge and practical skills that help strengthen their abilities to detect, document, respond to, and report unusual health events. Between May 2014 and May 2015, KFELTP hosted five training courses across the country to address practice gaps among local public health workers. Participants completed a 10-week process: two 1-week didactic courses, a 7-week field project, and a final 1-week course to present and defend the findings of their field project. The first year was a pilot period to determine whether the program could fit into the existing 2-year KFELTP model and whether this frontline-level training would have an impact on local practice. At the end of the first year, KFELTP certified 167 frontline health workers in field epidemiology and data management. This paper concludes that local, national, and international partnerships are critical for improving local public health response capacity and workforce development training in an African setting.

Catalysts for implementation of One Health in Kenya.

The recent Zika outbreak in the Americas, Ebola epidemic in West Africa and the increased frequency and impact of emerging and re-emerging infections of animal origin have increased the calls for greater preparedness in early detection and responses to public health events. One-Health approaches that emphasize collaborations between human health, animal health and environmental health sectors for the prevention, early detection and response to disease outbreaks have been hailed as a key strategy. Here we highlight three main efforts that have progressed the implementation of One Health in Kenya.

Did the call for boycott by the Catholic bishops affect the polio vaccination coverage in Kenya in 2015? A cross-sectional study.

INTRODUCTION: Polio eradication is now feasible after removal of Nigeria from the list of endemic countries and global reduction of cases of wild polio virus in 2015 by more than 80%. However, all countries must remain focused to achieve eradication. In August 2015, the Catholic bishops in Kenya called for boycott of a polio vaccination campaign citing safety concerns with the polio vaccine. We conducted a survey to establish if the coverage was affected by the boycott. METHODS: A cross sectional survey was conducted in all the 32 counties that participated in the campaign. A total of 90,157 children and 37,732 parents/guardians were sampled to determine the vaccination coverage and reasons for missed vaccination. RESULTS: The national vaccination coverage was 93% compared to 94% in the November 2014 campaign. The proportion of parents/guardians that belonged to Catholic Church was 31% compared to 7% of the children who were missed. Reasons for missed vaccination included house not being visited (44%), children not being at home at time of visit (38%), refusal by parents (12%), children being as leep (1%), and various other reasons (5%). Compared to the November 2014 campaign, the proportion of children who were not vaccinated due to parent's refusal significantly increased from 6% to 12% in August 2015. CONCLUSION: The call for boycott did not affect the campaign significantly. However, if the call for boycott is repeated in future it could have some significant negative implication to polio eradication. It is therefore important to ensure that any vaccine safety issues are addressed accordingly.

Implementation and Operational Research: Effects of Antenatal Care and HIV Treatment Integration on Elements of the PMTCT Cascade: Results From the SHAIP Cluster-Randomized Controlled Trial in Kenya.

BACKGROUND: Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. This study aimed to determine whether integration of HIV services into ANC settings improves PMTCT service utilization outcomes. METHODS: ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or nonintegrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. RESULTS: HIV care enrollment was higher in intervention compared with control clinics [69% versus 36%; odds ratio = 3.94, 95% confidence interval (CI): 1.14 to 13.63]. Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, hazard ratio = 2.20, 95% CI: 1.62 to 3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%; odds ratio = 3.22, 95% CI: 1.81 to 5.72). Infant testing was more common in the intervention arm (25% versus 18%), however, not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. CONCLUSIONS: Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions.

Integration of HIV Care with Primary Health Care Services: Effect on Patient Satisfaction and Stigma in Rural Kenya.

HIV departments within Kenyan health facilities are usually better staffed and equipped than departments offering non-HIV services. Integration of HIV services into primary care may address this issue of skewed resource allocation. Between 2008 and 2010, we piloted a system of integrating HIV services into primary care in rural Kenya. Before integration, we conducted a survey among returning adults ≥18-year old attending the HIV clinic. We then integrated HIV and primary care services. Three and twelve months after integration, we administered the same questionnaires to a sample of returning adults attending the integrated clinic. Changes in patient responses were assessed using truncated linear regression and logistic regression. At 12 months after integration, respondents were more likely to be satisfied with reception services (adjusted odds ratio, aOR 2.71, 95% CI 1.32-5.56), HIV education (aOR 3.28, 95% CI 1.92-6.83), and wait time (aOR 1.97 95% CI 1.03-3.76). Men's comfort with receiving care at an integrated clinic did not change (aOR = 0.46 95% CI 0.06-3.86). Women were more likely to express discomfort after integration (aOR 3.37 95% CI 1.33-8.52). Integration of HIV services into primary care services was associated with significant increases in patient satisfaction in certain domains, with no negative effect on satisfaction.

Factors influencing the performance of community health workers in Kisumu West, Kenya.

BACKGROUND: Community Health Workers (CHWs) play a key role in the functioning of Primary Health Care. However, little research on the performance of CHWs has been conducted in Kenya. This study aims to describe their performance and to determine which factors most impacted the performance of CHWs in Kenya. METHODS: A total of 750 CHWs were identified as potential subjects. However, appropriate data were submitted by 172 CHWs because of rejection and loss of their reporting status. Data on CHWs were collected through questionnaires, and information about their performance was gathered from their supervisors. RESULTS: Approximately 60% of the CHWs were active. CHWs over 40 years of age were likely to display good performance in their job (P < 0.001). In addition, the performance of CHWs was influenced by training partners (P < 0.03). CONCLUSION: Older CHWs were likely to perform well. Furthermore, their performance was influenced by their training partners.

Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment.

OBJECTIVES: To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers. METHODS: Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal. RESULTS: Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8-14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was "very easy" compared with the forceps-guided procedure. CONCLUSION: The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.