Single-arm evaluation of the AccuCirc device for early infant male circumcision in Botswana.
Ontology highlight
ABSTRACT:
SUBMITTER: Plank RM
PROVIDER: S-EPMC4041082 | biostudies-literature | 2014 May
REPOSITORIES: biostudies-literature
Publications
Single-arm evaluation of the AccuCirc device for early infant male circumcision in Botswana.
Plank Rebeca M RM Wirth Kathleen E KE Ndubuka Nnamdi O NO Abdullahi Rasak R Nkgau Maggie M Lesetedi Chiapo C Powis Kathleen M KM Mmalane Mompati M Makhema Joseph J Shapiro Roger R Lockman Shahin S
Journal of acquired immune deficiency syndromes (1999) 20140501 1
: Existing devices for early infant male circumcision (EIMC) have inherent limitations. We evaluated the newly developed AccuCirc device by circumcising 151 clinically well, full-term male infants with birth weight ≥2.5 kg within the first 10 days of life from a convenience sample in 2 hospitals in Botswana. No major adverse events were observed. There was 1 local infection, 5 cases of minor bleeding, and 1 case of moderate bleeding. In 3 cases, the device made only partial incisions that were c ...[more]
Similar Datasets
Project description:As countries scale up adult voluntary medical male circumcision (VMMC) for HIV prevention, they are looking ahead to long term sustainable strategies, including introduction of early infant male circumcision (EIMC). Although a number of devices for EIMC are prequalified by the World Health Organization, evaluation of additional devices can provide policy-makers and clinicians the information required to make informed decisions. We undertook a field evaluation of the safety and acceptability of the AccuCirc device in Kisumu County, Kenya.Procedures were performed by four trained clinicians in two public facilities. Participants were recruited from surrounding public health facilities through informational talks at antenatal clinics, maternity wards, and maternal neonatal child health clinics. Healthy infants ages 0-60 days, with no penile abnormality, without a family history of bleeding disorder, with current weight-for-age within -2 Z-scores of WHO growth standards, and whose mother was at least 16 years of age were eligible for EIMC. The procedure was performed after administration of a penile dorsal nerve block using 2% lidocaine and administration of Vitamin K. The mother was given post-operative instructions on wound care and asked to remain in the clinic with the baby for an observational period of one hour, during which a face-to-face questionnaire was administered.Of 1259 babies screened, 704 were enrolled and circumcised. Median age of the infants was 16 days (IQR: 7-32.5) and of the mothers was 26 years (IQR: 22-30). Median time for the procedure was 19 minutes (IQR: 15-23). There were no serious adverse events (AE), and 20 (2.8%) moderate AEs, all of which were due to bleeding that required application of one to three sutures. There were 22 (3.8%) procedures in which the device did not fully incise the entire circumference of the foreskin and had to be completed using sterile scissors. 89.9% of mothers had knowledge of EIMC, but few (8.1%) had any knowledge of devices used for EIMC. Protection against HIV/AIDS was the most cited reason to circumcise a baby (65.3%), while the baby being ill (38.1%) and pain (34.4%) were the most cited barriers to uptake. 99% of mothers were "very satisfied" or "completely satisfied" with the procedure.This evaluation of the AccuCirc device is the largest to date and indicates that the device is safe and acceptable, achieving high levels of parental satisfaction. The AccuCirc device should be considered for WHO prequalification to increase options for safe and sustainable provision of EIMC.
| S-EPMC5812570 | biostudies-literature
Project description:Early infant (1-60 days of life) male circumcision is being trialed in Africa as a human immunodeficiency virus prevention strategy. Postcircumcision bleeding is particularly concerning where most infants are breastfed, and thus these infants are at increased risk of vitamin K deficiency bleeding.During a circumcision trial, one infant bled for 90 minutes postprocedure. After discovering he had not received standard prophylactic vitamin K, we gave 2 mg phytomenadione (vitamin K1) intramuscularly; bleeding stopped within 30 minutes.Vitamin K's extremely rapid action is not commonly appreciated. Neonatal vitamin K has been shown to be cost-effective. To increase availability and promote awareness of its importance, especially in low-resource settings where blood products and transfusions are limited, vitamin K should be included in the World Health Organization's Model List of Essential Medicines for Children.
| S-EPMC3773869 | biostudies-literature
Project description:Unprotected sexual intercourse after undergoing voluntary medical male circumcision but prior to complete wound healing can lead to major adverse events including HIV acquisition. To better understand perceptions related to early resumption of sex prior to wound healing, 27 focus group discussions were conducted among 238 adult men, women, and community leaders in Botswana. Median age among all participants was 31 years of whom 60% were male and 51% were either employed and receiving salary or self-employed. Only 12% reported being currently married. Pain, not risk of HIV acquisition, was perceived as the main adverse consequence of early resumption of sex. In fact, no participant mentioned that early resumption of sex could lead to an increase in HIV risk. Demonstrating masculinity and virility, fear of losing female partners, and misperception about post-operative wound healing also played key roles in the decision to resume sex prior to complete wound healing. Findings from this study highlight a potentially widespread lack of awareness of the increased risk of HIV acquisition during the wound healing period. Strengthening post-operative counseling and identifying strategies to discourage the early resumption of sex will be increasingly important as older men and HIV-positive men seek voluntary medical male circumcision services.
| S-EPMC5685600 | biostudies-literature
Project description:Voluntary Medical Male Circumcision (VMMC) is an effective strategy for HIV prevention in areas with high prevalence of, and risk for, HIV. More than 361,000 male neonates are born each year in Zambia, many of whom could be eligible for Early-Infant Medical Circumcision (EIMC). Building on successful implementation strategies utilized in our Spear & Shield program, this pilot study, "Like Father, Like Son" (LFLS), evaluated the feasibility and acceptability of offering combined EIMC and VMMC services and couple-level behavioral interventions. A total of N = 702 pregnant women and their male partners (n = 351 couples) were recruited and enrolled. Couples were assessed twice pre-birth, 2 weeks post birth, and 6 months post birth. Expectant mothers were an average of 15.05 weeks pregnant (SD = 8.83). Thirty-nine pregnancies did not result in a live birth (11%), 14 couples withdrew from the study or were lost to follow-up prior to delivery (4%), and 148 babies were born female (42%), leaving 150 couples with a male infant in the analytic sample (43%). The LFLS study achieved significantly higher EIMC rates (35%) in comparison with previously observed EIMC study rates in Zambia (11%), and significantly higher than hypothetical comparison rates up to 30%. Relative to baseline rates, odds of VMMC among couples' older sons increased by 31% at post-intervention and by 90% at two-weeks following birth. Overall, this pilot study found the LFLS intervention to be feasible, acceptable, and effective in doubling the rate of EIMC in comparison with a previous longitudinal study in Zambia. Future research should consider a family-centric approach to promotion of male circumcision for infants and adolescents. LFLS may be effective in promoting father-son "bonding" by MC status; a bond that may be a bridge to increase both EIMC and VMMC uptake in newborns and couples' older sons and is a novel leverage point for promotion of this HIV prevention strategy.
| S-EPMC10414584 | biostudies-literature
Project description:BackgroundMale circumcision is almost universal in North and West Africa, and practiced for various reasons. Yet there is little documentation on service delivery, clinical procedures, policies, and programmatic strategies. The United Nations Children's Fund (UNICEF) commissioned country program reviews in 2014 to shed light on the delivery of male circumcision services for infants in Cameroon and Senegal.MethodsWe conducted a policy desk review, key informant interviews, and focus group discussions at health centers and in communities. Between December 2014 and January 2015, we conducted 21 key informant interviews (13 with regional and district officers, 5 with national officers, and 3 with UNICEF officials) and 36 focus group discussions (6 with men, 6 with women, 12 with adolescent boys, and 12 with service providers). Some of the men and women were parents of the adolescents who participated in the focus group discussions. In the French-speaking areas, the focus group discussions were conducted in French through an accredited translator, audio recorded, and transcribed into English.ResultsAll of the facilities we visited in Cameroon and Senegal offer medical male circumcision, with 10 out of 12 performing early infant male circumcision (EIMC) routinely. Neither country has policies, guidelines, or strategies for EIMC. The procedure is done mainly by untrained service providers, with some providers using modern circumcision devices. There are no key messages on EIMC for families; the increasing demand for EIMC is led by the community.ConclusionDespite the absence of national policies and strategies, EIMC is routinely offered at all levels of the health care system in Cameroon and Senegal, mainly by untrained service providers. Improving circumcision services will require guidelines for EIMC and improvements in training, equipment, supply chains, recordkeeping, and demand creation.
| S-EPMC4944576 | biostudies-literature
Project description:The emerging science demonstrates various health benefits associated with infant male circumcision and adult male circumcision; yet rates are declining in the United States. The American Academy of Pediatrics and the Centers for Disease Control and Prevention recommend that healthcare providers present evidence-based risk and benefit information for infant male circumcision to parent(s) and guardian(s). The purpose of this study was to assess providers' level of infant male circumcision knowledge and to identify the associated characteristics.An online survey was administered to healthcare providers in the family medicine, obstetrics, and pediatrics medical specialties at an urban academic health center. To assess infant male circumcision knowledge, a 17 point summary score was constructed to identify level of provider knowledge within the survey.Ninety-two providers completed the survey. Providers scored high for the following knowledge items: adverse event rates, protects against phimosis and urinary tract infections, and does not prevent hypospadias. Providers scored lower for items related to more recent research: protection against cervical cancer, genital ulcer disease, bacterial vaginosis, and reduction in HIV acquisition. Two models were constructed looking at (1) overall knowledge about male circumcision, and (2) knowledge about male circumcision reduction in HIV acquisition. Pediatricians demonstrated greater overall infant male circumcision knowledge, while obstetricians exhibited significantly greater knowledge for the HIV acquisition item.Providers' knowledge levels regarding the risks and benefits of infant male circumcision are highly variable, indicating the need for system-based educational interventions.
| S-EPMC4312077 | biostudies-other
Project description:BackgroundMale circumcision can reduce the risk of heterosexually acquired HIV-1 infection in men. Neonatal male circumcision (NMC) has many potential advantages over circumcision at older ages, but little is known about its feasibility and safety in resource-limited settings.MethodsWe performed a randomized trial in southeastern Botswana of Mogen clamp and Plastibell, 2 commonly used devices for NMC. Follow-up visits occurred at 6 weeks and 4 months postpartum. Adverse events, parental satisfaction, and staff impressions were recorded.ResultsOf 302 male neonates randomized, 300 (99%) underwent circumcision, 153 (51%) with Mogen clamp, and 147 (49%) with Plastibell. There were no major adverse events in the Mogen clamp arm, but there were 2 major adverse events in the Plastibell arm (both were a proximally migrated ring that had to be removed by study staff). Minor adverse events were more common with the Mogen clamp compared with the Plastibell, specifically removal of too little skin and formation of skin bridges or adhesions (12 versus 1 and 11 versus 3, respectively, all P < 0.05). Five (3%) infants in the Mogen clamp arm and none in the Plastibell arm had minor bleeding (P = 0.03). More than 94% of mothers reported being highly or completely satisfied with the procedure.ConclusionsNMC can be performed in Botswana with a low rate of adverse events and high parental satisfaction. Although the risk of migration and retention of the Plastibell is small, the Mogen clamp may be safer for NMC in regions where immediate emergent medical attention is not available.
| S-EPMC3683122 | biostudies-literature
Project description:BACKGROUND:Partnerships in global health and development governance have been firmly established as a tool to achieve effective outcomes. Botswana implements Safe Male Circumcision (SMC) for HIV prevention through a North-South partnership comprising the local Ministry of Health, US Centers for Disease Control and Prevention (funded by PEPFAR) and Africa Comprehensive HIV/AIDS Partnership (funded by the Bill and Melinda Gates Foundation). The SMC partnership experienced significant antagony and the aim of this paper is to illuminate the actions and processes in the SMC program that contributed to that antagony. METHODS:Methods used to gather data include observation of the partners' planning and strategic meeting in 2012, in-depth interviews with lead officers at national level, focus group discussions with district officers and implementers, younger male officers and old community members as recipients of the service. RESULTS:The findings reveal that the partnership experienced antagony during operational processes and as the ultimate outcome. Target setting, financial power of the North, superficial ownership given to the South, ignoring local traditional realities results in antagony. Three roots of antagony have been identified: 1. therapeutic domination-medical expertise given with arrogance; 2.iatrogenic violence-good intentions that cause unintended harm; 3. the Trojan horse-Reckless acceptance of the gift as well as deceptive power positioned under the pretext of benevolence. CONCLUSION:The three roots of antagony; therapeutic domination, iatrogenic violence and the Trojan horse, constitute attitudes, hidden intentions and unintended consequences that influence program implementation and cause harm at different levels. Examples of therapeutic domination and the Trojan horse have highlighted the need for vigilance at the stage of establishing a partnership, to prevent more powerful partners from developing and applying hidden agendas and to strengthen accountability from the local partner. Iatrogenic violence has highlighted the need for partnership interventions to prevent good partner intentions accidentally producing bad outcomes.
| S-EPMC6147398 | biostudies-other
Project description:Randomized trials have shown that voluntary medical male circumcision (VMMC) significantly reduces the risk of HIV acquisition in men. However, the rate of complications associated with the surgical procedure varies from 0.7% to 37.4% in real-world settings. We assessed the frequency, type and severity of adverse events following VMMC among 427 adult men surgically circumcised in southeastern Botswana; 97% completed ?1 follow-up visit within seven days post-circumcision. Thirty moderate AEs were observed in 28 men resulting in an overall AE rate of 6.7%. Patient satisfaction was high: >95% were very or somewhat satisfied with the procedure and subsequent follow-up care.
| S-EPMC5675416 | biostudies-other
Project description:ObjectiveTo systematically evaluate evidence against male circumcision (MC).MethodsWe searched PubMed, Google Scholar, EMBASE and Cochrane databases.ResultsDatabase searches retrieved 297 publications for inclusion. Bibliographies of these yielded 101 more. After evaluation we found: Claims that MC carries high risk were contradicted by low frequency of adverse events that were virtually all minor and easily treated with complete resolution. Claims that MC causes psychological harm were contradicted by studies finding no such harm. Claims that MC impairs sexual function and pleasure were contradicted by high-quality studies finding no adverse effect. Claims disputing the medical benefits of MC were contradicted by a large body of high-quality evidence indicating protection against a wide range of infections, dermatological conditions, and genital cancers in males and the female sexual partners of men. Risk-benefit analyses reported that benefits exceed risks by 100-200 to 1. To maximize benefits and minimize risks, the evidence supported early infant MC rather than arguments that the procedure should be delayed until males are old enough to decide for themselves. Claims that MC of minors is unethical were contradicted by balanced evaluations of ethical issues supporting the rights of children to be provided with low-risk, high-benefit interventions such as MC for better health. Expert evaluations of case-law supported the legality of MC of minors. Other data demonstrated that early infant MC is cost-saving to health systems.ConclusionsArguments opposing MC are supported mostly by low-quality evidence and opinion, and are contradicted by strong scientific evidence.
| S-EPMC6899915 | biostudies-literature