Meaningful Engagement of People Living With Noncommunicable Diseases: Challenges and Opportunities.

Meaningful engagement of people living with health conditions means actively incorporating them in all stages of health decision-making. Despite efforts by global health agencies and governments towards meaningful engagement of people living with noncommunicable diseases (PLWNCDs), many opportunities for participation are tokenistic. PLWNCDs often report feeling excluded from technical discussions and outnumbered by other stakeholders. Participation in decision-making is a human right, and PLWNCDs must continue advocating for a "nothing about us without us" approach. They should be respected as decision-makers with voice, agency, voting power, rights, and duties. This article highlights four key themes: (1) both tokenistic participation and exclusion of PLWNCDs from technical discussions are still common; (2) the "patient" label implies passivity and can perpetuate limited participation, whereas the identifier of PLWNCDs connotes valuable knowledge associated with lived experience; (3) meaningful participation of PLWNCDs in health decision-making processes should be considered a human right; (4) PLWNCD should be empowered to continue to advocate for inclusion and be respected as decision-makers.

ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial.

BACKGROUND: Use of medical devices represents a unique opportunity to facilitate scale-up of early infant male circumcision (EIMC) across sub-Saharan Africa. The ShangRing, a circumcision device prequalified by WHO, is approved for use in adults and adolescents and requires topical anaesthesia only. We aimed to investigate the safety and efficacy of the ShangRing versus the Mogen clamp for EIMC in infants across eastern sub-Saharan Africa. METHODS: In this multicentre, non-inferiority, open-label, randomised controlled trial, we enrolled healthy male infants (aged <60 days), with a gestational age of at least 37 weeks and a birthweight of at least 2·5 kg, from 11 community and referral centres in Kenya, Tanzania, and Uganda. Infants were randomly assigned (1:1) by a computer-generated text message service to undergo EIMC by either the ShangRing or the Mogen clamp. The primary endpoint was safety, defined as the number and severity of adverse events (AEs), analysed in the intention-to-treat population (all infants who underwent an EIMC procedure) with a non-inferiority margin of 2% for the difference in moderate and severe AEs. This trial is registered with Clinical. TRIALS: gov, NCT03338699, and is complete. FINDINGS: Between Sept 17, 2018, and Dec 20, 2019, a total of 1420 infants were assessed for eligibility, of whom 1378 (97·0%) were enrolled. 689 (50·0%) infants were randomly assigned to undergo EIMC by ShangRing and 689 (50·0%) by Mogen clamp. 43 (6·2%) adverse events were observed in the ShangRing group and 61 (8·9%) in the Mogen clamp group (p=0·078). The most common treatment-related AE was intraoperative pain (Neonatal Infant Pain Scale score ≥5), with 19 (2·8%) events in the ShangRing and 23 (3·3%) in the Mogel clamp group. Rates of moderate and severe AEs were similar between both groups (29 [4·2%] in the ShangRing group vs 30 [4·4%] in the Mogen clamp group; difference -0·1%; one-sided 95% CI upper limit of 1·7%; p=0·89). No treatment-related deaths were reported. INTERPRETATION: Use of the ShangRing device for EIMC showed safety, achieved high caregiver satisfaction, and did not differ from the Mogen clamp in other key measures. The ShangRing could be used by health systems and international organisations to further scale up EIMC across sub-Saharan Africa. FUNDING: Bill & Melinda Gates Foundation.

Oral Health Knowledge and Habits of People With Type 1 and Type 2 Diabetes.

OBJECTIVES: This study aimed to collect information about oral health knowledge and the habits of people living with diabetes (PwD), primarily type 1 diabetes, using the newly developed World Health Organisation Oral Health Questionnaire for Adults (Annex 7). MATERIALS AND METHODS: Comparable and reliable questionnaires, comprising 23 questions for PwD, were sent to diabetes social media groups, mailing lists, and associations. The survey explored the relationships amongst demographic factors, age, dental education, eating habits, and other factors. RESULTS: The 23-question survey was answered by 307 individuals from 60 different countries. Alcohol and tobacco use, dental anxiety, and bad habits were often reported. Of the participants, 61.2% (n = 188) had at least 1 drink during the past 30 days. Of the participants, 22.8% (n = 70) were smokers. In total, 80.8% (n = 248) of the participants consumed biscuits, 76.2% (n = 234) consumed sweets, and 63.2% (n = 194) consumed soft drinks regularly. A total of 26.4% (n = 81) of the participants reported being afraid of dental treatment. Of the participants, 48.5% (n = 149) reported dry mouth and other oral complications. The frequency of visits to the dentist was satisfactory. A total of 71.3% (n = 219) of the participants reported visiting a dentist during the past 12 months. CONCLUSIONS: There is a need for proper oral health education for PwD. Trained diabetes advocates could be core messengers. However, interdisciplinary cooperation is mandatory for both education and the clinical aspect of diabetes care. For example, diabetes nurses need to be educated with the help of dentists or oral hygienists.

COVID-19 associated with diabetes and other noncommunicable diseases led to a global health crisis.

COVID-19 has gravely threatened high-risk populations, such as people with diabetes and other noncommunicable diseases, leading to disproportionate hospitalizations and deaths worldwide. It is well documented from previous outbreaks that diabetes increases the risk for poor outcomes due to SARS infection. In the present review, we bring evidence that the country and global level health crisis caused by COVID-19 could have been avoided or extremely minimized if measures to protect high-risk populations were implemented timely. In addition to general lockdowns, testing, tracing, isolation and hygiene measures, other specific interventions for diabetes and comorbidities management were shown crucial to allow the continuation of care services during the pandemic. These interventions included: teleconsultation, digital remote education andmonitoring, e-prescriptions, medicine delivery options, mobile clinics, and home point-of-care tests. In conclusion, we recommend prompt actions to protect the most vulnerable groups, valuing knowledge and experiences from previous outbreaks and lessons learned during the COVID-19 pandemic, in order to shield communities, health systems and the global economy.

Sleep-wake cycle impairment adding on the risk for COVID-19 severity in people with diabetes.

In the present article, we explore the risks of circadian disruptions and impact on the sleep-wake cycle of individuals with diabetes during COVID-19 pandemic. The association between the duration and quality of sleep and the stability of glucose levels is well-established. Therefore, during the pandemic with changes and limitations in the exposure to cyclic cues that entrain the circadian rhythms, such as light-dark and social interactions, we hypothesize that the power and stability of circadian rhythms decrease if measures are not taken to intentionally create a routine that includes zeitgebers. Knowing that sleep-wake cycle disruptions impair melatonin production, immune system response and glucose metabolism, and that individuals with diabetes are at higher risk for poor prognosis when infected by SARS-CoV-2 (especially if their blood glucose is out of target), we recommend monitoring and advising these individuals towards strategies to maintain adequate sleep quality and duration as part of their preventive and protective measures during the new pandemic routine.

Decentralized COVID-19 measures in Brazil were ineffective to protect people with diabetes.

BACKGROUND AND AIMS: COVID-19 severity and mortality are elevated in individuals with diabetes. During the pandemic, interventions recommended globally for people with diabetes were to keep blood glucose on target whilst staying at home to curb the spread of the virus. In Brazil, similar measures were proposed. The aim of our observational study was to assess whether these measures achieved their objectives. METHODS: An anonymous and untraceable survey was shared from April 22nd to May 4th. States with more than 30 respondents were included in the analysis and Fisher's exact test was performed to identify associations, with p < 0.05 considered significant. RESULTS: Type 1 diabetes and female participants were prevalent, 60.76% and 76.12% respectively. 10 out of 26 states were included, in addition to the Federal District (1562 responses). Only in three states (Bahia, Goiás and Pernambuco) less than 50% of the respondents experienced higher glycemia or higher variability during the pandemic. Goiás state, where almost half of the respondents (49.12%) have private insurance, presented the highest percentage of individuals receiving medicines for three months (35.48%) and one of the lowest percentages of blood glucose deterioration (47.17%). In the large states of Minas Gerais, Rio de Janeiro and São Paulo, consultations and/or lab exams were postponed by 37.14%, 34.33% and 40.88%, respectively. CONCLUSIONS: The decentralized measures implemented by states in Brazil left most people with diabetes unprotected. Many were forced to venture outside to collect or to purchase their medical supplies monthly and reported increased glycemic levels and/or variability.

COVID-19 impact on people with diabetes in South and Central America (SACA region).

AIMS: The present observational study aims to describe political actions in place to combat COVID-19 in the South and Central America region (SACA) while protecting individuals with diabetes. METHODS: A survey with 12 questions was shared with all IDF-SACA member organizations, in 18 countries. A descriptive analysis was performed and a multivariate cluster analysis technique pam (partitioning around medoids) was applied. RESULTS: Two groups of countries were identified. The first group, mostly countries with stricter measures to contain the spread of the virus, reported more difficulties (limitations in accessing basic or health needs) and fears (concerns regarding the impact of the pandemic); whereas most of the second group consisted of countries with less restrictive measures, and reported fewer difficulties. Only 37% responded that a policy was put into place to protect individuals with diabetes, either delivering their medicines and supplies at home (16%) or providing them at once enough for 2-3 months (21%). All respondents reported that one of the main fear was to "be infected and not to receive adequate treatment" and/or "getting infected if going to the hospital or medical appointments". CONCLUSION: Most of the SACA countries failed to implement timely measures to protect individuals with diabetes, which may severely impact individuals, health systems and economies.

The impact of COVID-19 on people with diabetes in Brazil.

The present study aims at identifying main barriers faced by people living with diabetes in Brazil during the COVID-19 pandemic. METHODS: In a convenience sampling study, data were collected from 1701 individuals, aged 18 or above; 75.54% female participants; 60.73% T1D and 30.75% T2D, between April 22nd and May 4th, using an anonymous and untraceable survey containing 20 multiple choice questions (socio-demographic; health status and habits of life during COVID-19 pandemic). Relationship between variables was established using the multiple correspondence analysis technique. RESULTS: 95.1% of respondents reduced their frequency of going outside of their homes; among those who monitored blood glucose at home during the pandemic (91.5%), the majority (59.4%) experienced an increase, a decrease or a higher variability in glucose levels; 38.4% postponed their medical appointments and/or routine examinations; and 59.5% reduced their physical activity. T1D, the youngest group, was more susceptible to presenting COVID-19 symptoms despite not being testing; whilst the T2D group had higher frequency of comorbidities that are additional risk factors for COVID-19 severity. CONCLUSIONS: This study provides a first hand revelation of the severity of COVID-19 on individuals with diabetes in Brazil. Their habits were altered, which impacted their glycemia, potentially increasing the risk of poor outcomes and mortality if infected by SARS-CoV-2, and of acute and chronic diabetes complications.

Community-based interventions for detection and management of diabetes and hypertension in underserved communities: a mixed-methods evaluation in Brazil, India, South Africa and the USA.

INTRODUCTION: As non-communicable disease (NCD) burden rises worldwide, community-based programmes are a promising strategy to bridge gaps in NCD care. The HealthRise programme sought to improve hypertension and diabetes management for underserved communities in nine sites across Brazil, India, South Africa and the USA between 2016 and 2018. This study presents findings from the programme's endline evaluation. METHODS: The evaluation utilises a mixed-methods quasi-experimental design. Process indicators assess programme implementation; quantitative data examine patients' biometric measures and qualitative data characterise programme successes and challenges. Programme impact was assessed using the percentage of patients meeting blood pressure and A1c treatment targets and tracking changes in these measures over time. RESULTS: Almost 60 000 screenings, most of them in India, resulted in 1464 new hypertension and 295 new diabetes cases across sites. In Brazil, patients exhibited statistically significant reductions in blood pressure and A1c. In Shimla, India, and in South Africa, country with the shortest implementation period, there were no differences between patients served by facilities in HealthRise areas relative to comparison areas. Among participating patients with diabetes in Hennepin and Ramsey counties and hypertension patients in Hennepin County, the percentage of HealthRise patients meeting treatment targets at endline was significantly higher relative to comparison group patients. Qualitative analysis identified linking different providers, services, communities and information systems as positive HealthRise attributes. Gaps in health system capacities and sociodemographic factors, including poverty, low levels of health education and limited access to nutritious food, are remaining challenges. CONCLUSIONS: Findings from Brazil and the USA indicate that the HealthRise model has the potential to improve patient outcomes. Short implementation periods and strong emphasis on screening may have contributed to the lack of detectable differences in other sites. Community-based care cannot deliver its full potential if sociodemographic and health system barriers are not addressed in tandem.

No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya.

BACKGROUND: Attention has recently turned toward the use of device-assisted male circumcision to help scale up male circumcision services in sub-Saharan Africa, with increasing emphasis on younger age groups. We assessed the use of the ShangRing for circumcising the subset of boys aged 10 to 12 years who were enrolled in two randomized clinical trials in Kenya. METHODS: We performed a sub-analysis of outcomes in 197 boys aged 10 to 12 years; a subset who were enrolled in two randomized clinical trials to assess the use of the no-flip ShangRing circumcision technique in men and boys. One trial assessed spontaneous detachment vs. planned removal of the ShangRing 7 days post-circumcision. The second trial compared the use of topical vs. injectable anesthesia with ShangRing circumcision. Aside from baseline characteristics, data was collected and analyzed for each trial separately. RESULTS: All participants were successfully circumcised. Duration of circumcision, participants requiring a dorsal slit, rate of adverse events, time to complete wound healing, and participant satisfaction were similar between the two groups in each trial. Mean time required for spontaneous ShangRing detachment was 14.82±3.76 days. Topical anesthesia showed a significantly lower mean pain score at the time of application (0.64±1.71 vs. 1.55± 2.21, p = 0.03) as well as postoperatively (0.54±0.88 vs. 1.72±1.56, p<0.0001). Median dwell time of the topical anesthetic was 43 (IQR: 35.5-60) minutes, while the median time it took the injectable anesthetic to take effect was 2.04 (IQR: 1.72-3.09) minutes. CONCLUSION: No-flip ShangRing circumcision had a positive safety profile among young adolescent boys, specifically ages 10-12 years. The use of spontaneous device detachment and topical anesthesia with the procedure have shown promising outcomes in this age group. This may have the potential to further increase the acceptability of ShangRing circumcision, and therefore accelerate the scle up of male circumcision services in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov registration # NCT02390310.

Cost-Effectiveness of Point-of-Care A1C Tests in a Primary Care Setting.

Objective: We evaluated the cost-effectiveness of the point-of-care A1c (POC-A1c) test device vs. the traditional laboratory dosage in a primary care setting for people living with type 2 diabetes. Materials and Methods: The Markov model with a 10-year time horizon was based on data from the HealthRise project, in which a group of interventions was implemented to improve diabetes and hypertension control in the primary care network of the urban area of a Brazilian municipality. A POC-A1c device was provided to be used directly in a primary care unit, and for a period of 18 months, 288 patients were included in the point-of-care group, and 1,102 were included in the comparison group. Sensitivity analysis was performed via Monte Carlo simulation and tornado diagram. Results: The results indicated that the POC-A1c device used in the primary care unit was a cost-effective alternative, which improved access to A1c tests and resulted in an increased rate of early control of blood glucose. In the 10-year period, POC-A1c group presented a mean cost of US$10,503.48 per patient and an effectiveness of 0.35 vs. US$9,992.35 and 0.09 for the traditional laboratory test, respectively. The incremental cost was US$511.13 and the incremental effectiveness was 0.26, resulting in an incremental cost-effectiveness ratio of 1,947.10. In Monte Carlo simulation, costs and effectiveness ranged between $9,663.20-$10,683.53 and 0.33-0.37 for POC-A1c test group, and $9,288.28-$10,413.99 and 0.08-0.10 for traditional laboratory test group, at 2.5 and 97.5 percentiles. The costs for nephropathy, retinopathy, and cardiovascular disease and the probability of being hospitalized due to diabetes presented the greatest impact on the model's result. Conclusion: This study showed that using POC-A1c devices in primary care settings is a cost-effective alternative for monitoring glycated hemoglobin A1c as a marker of blood glucose control in people living with type 2 diabetes. According to our model, the use of POC-A1c device in a healthcare unit increased the early control of type 2 diabetes and, consequently, reduced the costs of diabetes-related outcomes, in comparison with a centralized laboratory test.

Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial.

BACKGROUND: The ShangRing is a disposable, collar clamp circumcision device pre-qualified for use in men and boys 13 years and above. It has been shown to be faster than conventional circumcision with comparable adverse event (AE) rates and high client satisfaction. Voluntary medical male circumcision (VMMC) has been shown to dramatically reduce the risk of HIV acquisition in males. However, the fear of pain during circumcision is an important barrier to uptake. Use of topical anesthesia thus presents an opportunity to address this. OBJECTIVES: We sought to evaluate the safety, effectiveness and acceptability of the use of topical anaesthesia with ShangRing circumcision of men and boys 10 years of age and above. METHODS: Participants were randomised 2:1 to receive topical or injectable anaesthesia. All participants underwent no-flip ShangRing circumcision. The primary outcome measure was pain. Secondary outcomes included ease of use of topical versus injectable anaesthesia, AEs and participant satisfaction. RESULTS: Compared to the topical group, participants in the injectable group reported significantly more pain on administration of the anesthesia and at approximately 20 minutes after the procedure. In the topical group, sufficient anaesthesia with topical cream was not achieved in 21 (9.3%) cases before the start of the procedure; in another 6 (2.6%), supplementary injectable anaesthesia was required as the circumcision was being carried out. The AE rate was significantly lower (p<0.01) in the topical (0%) vs. the injectable group (4.2%). The most common AE was pain during the post-operative period. All AEs were managed conservatively and resolved without sequeale. 96.7% of participants were satisfied with the appearance of the healed penis and 100% would recommend the ShangRing to others. All seven male circumcision providers involved in the study preferred topical to injectable anaesthesia. CONCLUSIONS: Our results demonstrate the safety, improved clinical experience, effectiveness, and acceptability of the use of topical anaesthesia in ShangRing circumcision using the no-flip technique. Topical anaesthesia effectively eliminates needlestick pain from the clients' VMMC experience and thus has the potential to increase demand for the service. TRIAL REGISTRATION: ClinicalTrials.gov NCT02390310.

Simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment.

To assess safety of the no-flip ShangRing male circumcision technique and to determine clinical course and safety of spontaneous detachment (i.e., allowing the device to fall off), we conducted a case series of no-flip ShangRing circumcision combined with a randomized controlled trial of removal 7 days postcircumcision versus spontaneous detachment at two health facilities in Kenya. The primary outcome was the safety of the no-flip technique based on moderate and severe adverse events (AEs) during the procedure and through 42-day follow-up. A main secondary outcome was clinical course and safety of spontaneous detachment. Two hundred and thirty males 10 years and older underwent no-flip circumcision; 114 randomized to 7-day removal and 116 to spontaneous detachment. All circumcisions were successfully completed. Overall 5.3% (6/114) of participants in the 7-day group and 1.7% (2/116) in the spontaneous group had an AE; with no differences when compared to the 3% AE rate in historical data from African studies using the original flip technique (P = 0.07 and P = 0.79, respectively). Overall 72.4% (84/116) of participants in the spontaneous group wore the ShangRing until it detached. Among the remaining (27.6%; 32/116), the ring was removed, primarily at the participants' request, due to pain or discomfort. There was no difference in AE rates (P = 0.169), visit day declared healed (P = 0.324), or satisfaction (P = 0.371) between randomization groups. The median time to detachment was 14.0 (IQR: 7-21, range: 5-35) days. The no-flip technique and spontaneous detachment are safe, effective, and acceptable to boys and men 10 years and older. Phimosis and penile adhesions do not limit successful ShangRing circumcision with the no-flip technique.

Peripheral body temperature impairment in individuals with type 1 diabetes mellitus.

OBJECTIVE: The aim of the present study was to evaluate the peripheral temperature rhythmicity and control in individuals with type 1 diabetes mellitus. METHODS: Twelve non-obese adults (20-40 years old) with type 1 diabetes mellitus (T1D) and eight control individuals, matched for age and BMI, wore a wrist temperature recorder for 10 consecutive days. Recorded data were aggregated to calculate M10 (ten hours of highest temperature) and L5 (five hours of lowest temperature) of wrist temperature values for both groups. RESULTS: Mean wrist temperature and M10 were not different when comparing the groups. The wrist temperature amplitude was reduced in the T1D group (p=0.039), due to a higher L5 (p=0.038). DISCUSSION: While the higher L5 observed in T1D could be explained by less efficient heat dissipation, the amplitude flattening coincides with that observed in elderly.

Safety of Tubal Occlusion by Minilaparotomy Provided by Trained Clinical Officers Versus Assistant Medical Officers in Tanzania: A Randomized, Controlled, Noninferiority Trial.

BACKGROUND: Tubal occlusion by minilaparotomy is a safe, highly effective, and permanent way to limit childbearing. We aimed to establish whether the safety of the procedure provided by trained clinical officers (COs) was not inferior to the safety when provided by trained assistant medical officers (AMOs), as measured by major adverse event (AE) rates. METHODS: In this randomized, controlled, open-label noninferiority trial, we enrolled participants at 7 health facilities in Arusha region, Tanzania, as well as during outreach activities conducted in Arusha and neighboring regions. Consenting, eligible participants were randomly allocated by a research assistant at each site to minilaparotomy performed by a trained CO or by a trained AMO, in a 1:1 ratio. We asked participants to return at 3, 7, and 42 days postsurgery. The primary outcome was the rate of major AEs following minilaparotomy performed by COs versus AMOs, during the procedure and through 42 days follow-up. The noninferiority margin was 2%. The trial is registered with ClinicalTrials.gov, Identifier NCT02944149. RESULTS: We randomly allocated 1,970 participants between December 2016 and June 2017, 984 to the CO group and 986 to the AMO group. Most (87%) minilaparotomies were conducted during outreach services. In the intent-to-treat analysis, 0 of 978 participants had a major AE in the CO group compared with 1 (0.1%) of 984 in the AMO group (risk difference: -0.1% [95% confidence interval: -0.3% to 0.1%]), meeting the criteria for noninferiority. We saw no evidence of differences in measures of procedure performance, participant satisfaction, or provider self-efficacy between the groups. CONCLUSIONS: Tubal occlusion by minilaparotomy performed by trained COs is safe, effective, and acceptable to women, and the procedure can be safely and effectively provided in outreach settings. Our results provide evidence to support policy change in resource-limited settings to allow task shifting of minilaparotomy to properly trained and supported COs, increasing access to female sterilization and helping to meet the rising demand for the procedure among women wanting to avoid pregnancy. They also suggest high demand for these services in Tanzania, given the large number of women recruited in a relatively short time period.

Safety of tubal ligation by minilaparotomy provided by clinical officers versus assistant medical officers: study protocol for a noninferiority randomized controlled trial in Tanzanian women.

BACKGROUND: Female sterilization by tubal ligation is a safe, extremely effective, and permanent way to limit childbearing. It is the most popular modern contraceptive method worldwide. The simplest way to provide tubal ligation is by a procedure called minilaparotomy, generally performed with the client under local anesthesia with systemic sedation and analgesia. In Tanzania, unmet need for family planning is high and has declined little in the past decade. Access to tubal ligation is limited throughout the country, in large part because of a lack of trained providers. Clinical officers (COs) are midlevel health workers who provide diagnosis, treatment, and minor surgeries. They are more prevalent than physicians in poorer and rural communities. Task shifting-the delegation of some tasks to less-specialized health workers, including task shifting of surgical procedures to midlevel cadres-has improved access to lifesaving interventions in resource-limited settings. It is a cost-effective way to address shortages of physicians, increasing access to services. The primary objective of this trial is to establish whether the safety of tubal ligation by minilaparotomy provided by COs is noninferior to the safety of tubal ligation by minilaparotomy provided by physicians (assistant medical officers [AMOs]), as measured by rates of major adverse events (AEs) during the procedure and through 42 days of follow-up. METHODS/DESIGN: In this facility-based, multicenter, noninferiority randomized controlled trial, we are comparing the safety of tubal ligation by minilaparotomy performed by trained COs versus by trained AMOs. The primary outcome is safety, defined by the overall rate of major AEs occurring during the minilaparotomy procedure and through 42 days of follow-up. The trial will be conducted among 1970 women 18 years of age or older presenting for tubal ligation at 7 study sites in northern Tanzania. DISCUSSION: If no major safety issues are identified, the data from this trial may facilitate changes in the Tanzanian government's regulations, allowing appropriately trained COs to provide tubal ligation by minilaparotomy. Positive findings may have broader implications. Task shifting to provide long-acting contraceptives, if proven safe, may be an effective approach to increasing contraceptive access in low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02944149 . Registered on 14 October 2016.

Use of the ShangRing circumcision device in boys below 18 years old in Kenya: results from a pilot study.

INTRODUCTION: Male circumcision is a proven prevention strategy against the spread of HIV. The World Health Organization's new 2016-2021 strategic framework on voluntary medical male circumcision (VMMC) targets 90% of males aged 10-29 years to receive circumcision by 2021 in 14 priority sub-Saharan countries while anticipating an increase in the demand for infant circumcision. It also states that the use of circumcision devices is a safe and efficient innovation to accelerate attainment of these goals. The primary objective of this pilot study was to evaluate the safety and acceptability of the ShangRing, a novel circumcision device, in boys below 18 years of age. METHODS: A total of 80 boys, 3 months to 17 years old, were circumcised using the no-flip ShangRing technique. All rings were removed 5-7 days later. Participants were evaluated weekly until the wound was completely healed. Data on procedure times, adverse events (AEs), time to clinical wound healing and satisfaction were recorded and analysed. RESULTS: Nearly all (79/80, 98.8%) circumcisions were successfully completed using the no-flip ShangRing technique without complications. In one (1.2%) case, the outer ring slipped off after the foreskin was removed and the procedure was completed by stitching. The mean circumcision and ring removal times were 7.4 ± 3.2 and 4.4 ± 4.2 min, respectively. There were four (5%) moderate AEs, which were managed conservatively. No severe AEs occurred. The mean time to complete clinical healing was 29.8 ± 7.3 days. Participants or their parents liked ShangRing circumcision because it improved hygiene, was quick and possessed an excellent cosmetic appearance. Most (72/80, 94.7%) were very satisfied with the appearance of the circumcised penis, and all (100%) said they would recommend circumcision to others. CONCLUSIONS: Our results suggest that no-flip ShangRing VMMC is safe and acceptable in boys below 18 years of age. Our results are to be compared those seen following ShangRing VMMC in African men. Further study with larger sample sizes are needed to explore the scalability of the ShangRing in larger paediatric cohorts in Africa. We believe that the ShangRing has great potential for use in all age groups from neonates to adults, which would simplify device implementation.

Surgical Outcomes of Newly Trained ShangRing Circumcision Providers.

BACKGROUND: Devices can potentially accelerate scale-up of voluntary medical male circumcision in sub-Saharan Africa. Studies have demonstrated advantages of the ShangRing device over conventional circumcision. With the need to train providers rapidly for scale-up, concerns arise about the transferability of techniques and the expertise of new trainees. METHODS: We compared outcomes of ShangRing circumcisions conducted in Kenya by experienced providers (experience with more than 100 ShangRing circumcisions) and newly trained providers (trained in Kenya by the experienced providers before the study began). During training, trainees performed at least 7 ShangRing circumcisions and 3 removals. Newly trained providers received intermittent clinical mentoring initially during the study but otherwise conducted circumcisions on their own. RESULTS: Four hundred six and 115 ShangRing procedures were performed by the new trainees and the experienced providers, respectively. The mean duration of circumcisions was 6.2 minutes for both trained and experienced provider groups (P = 0.45), whereas the mean pain score (on an 11-point scale) was 2.5 and 3.2, respectively (P = 0.65). There was no difference in the proportion of participants healed by the day 42 visit (P = 0.13) nor in the incidence of moderate and severe adverse events observed (P = 0.16). Participants in both groups were equally satisfied with final wound cosmesis. DISCUSSION: Results demonstrate that the ShangRing circumcision technique is easy to learn and master. Newly trained providers can safely conduct ShangRing circumcisions in routine service settings. The ShangRing can facilitate rapid rollout of voluntary medical male circumcision for HIV prevention in sub-Saharan Africa.