Early Infant Male Circumcision Research Articles

Early Infant Male Circumcision Decisions in Zambia: Demographic and Familial Influences

Public health initiatives in Zambia encourage the uptake of early infant male circumcision (EIMC) as an HIV prevention strategy. This study assessed EIMC parental decision-making during perinatal care in Lusaka, Zambia, focusing on the influence of sociodemographic factors, family, and friends. A longitudinal pilot perinatal intervention, Like Father Like Son (LFLS), was implemented among 300 couples attending antenatal clinics in four urban community health centers. Participants were assessed postpartum regarding subsequent EIMC decisions. Partners, religion, and marital status were associated with the EIMC decision-making. Large scale EIMC promotion interventions that target both parents during perinatal care should be explored.

Comparison of the penile microbiome in infant male circumcision: Mogen clamp versus Shangring

BackgroundThis study aimed to characterise the infant penile (coronal sulcus) microbiome and the effects of early infant male circumcision (EIMC), following a standard surgical method (Mogen Clamp) and a non-surgical alternative (ShangRing). MethodsWe collected coronal sulcus swabs at baseline and on days 7 and 14 post-circumcision from infants assigned to receive EIMC by Mogen Clamp (n = 15) or ShangRing (n = 15), in a randomised trial in Rakai and Kakuuto, Uganda. We used 16S rRNA gene-based sequencing and broad-coverage qPCR to characterise the infant penile microbiome and assess the effects of EIMC in both study arms. FindingsPrior to EIMC, the infant penile microbiome had a mixture of facultative and strict anaerobes. In both study arms, EIMC caused penile microbiome proportional abundance changes characterised by decreases in penile anaerobes [ShangRing Prevotella: -15.0%, (SD=19.1); Mogen clamp Prevotella: -3.6% (11.2); ShangRing Veillonella: -11.3% (17.2); Mogen clamp Veillonella: -2.6% (11.8)] and increases in skin-associated facultative anaerobes [ShangRing Corynebacterium: 24.9%, (22.4); Mogen clamp Corynebacterium: 4.7% (21.3); ShangRing Staphylococcus: 21.1% (20.5); Mogen clamp Staphylococcus: 18.1% (20.1)]. Clostridium tetani was not detected during the study. InterpretationMogen Clamp and ShangRing EIMC both changed the composition of the infant penile microbiome by reducing the proportional abundances of anaerobes and uropathogens, which is consistent with medical male circumcision findings in adults. C. tetani was not increased by either EIMC method. FundingBill and Melinda Gates Foundation.

Increasing early infant male circumcision uptake in Zambia: Like father like son.

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.

Factors influencing neonatal male circumcision uptake among expecting couples in Zambia: formative findings

ABSTRACT Male circumcision is a protective HIV prevention strategy. However, uncircumcised Zambian men are reluctant to undergo voluntary medical male circumcision (VMMC). Tailored interventions are necessary to stimulate the uptake of early infant male circumcision (EIMC) and VMMC in Zambia. This feasibility study presents the formative process of utilising the PRECEDE framework in the development of a family-centred EIMC/VMMC intervention, Like Father Like Son, and its application in an existing VMMC intervention, Spear & Shield. We found that fear of the pain associated with EIMC procedures, foreskin disposal, beliefs in children’s autonomy and rights, and men’s dominance in health decision-making were factors affecting EIMC uptake. Perceived benefits for infants included improved hygiene, protection from HIV infection, and faster recovery. Reinforcing factors included female partners and fathers’ MC status. The availability and access to EIMC services and information, skill and experience of health workers, and engagement and belief in traditional circumcision practices were factors enabling EIMC uptake. These individual, interpersonal, and structural factors positively and negatively influencing EIMC uptake in the Zambian clinic context were integrated into the intervention for expecting parents. Feedback from community advisory boards suggested the process was effective in developing a culturally tailored and acceptable EIMC/VMMC promotion intervention.

Early infant male circumcision: Potential for changing adverse gender norms associated with traditional male circumcision among circumcising communities in Kenya

Introduction: Traditional male circumcision (TMC) inculcates masculine-dominance norms in young men. Early infant male circumcision (EIMC) and medical male circumcision (MMC) can potentially minimise these adverse gender norms. We explored the perceptions about EIMC and MMC among communities practising TMC in Kenya. Method: We conducted focus group discussions with men and women and councils of elders, and key informant interviews with traditional circumcisers. Data were analysed using NVivo 10. Results: Most participants described MC as a rite of passage into adulthood, with the preferred age for MC to occur at 10 to 15 years old. Interestingly, awareness of the advantages of EIMC, especially among younger men and women, was high. Participants acknowledged that TMC reinforces hegemonic masculinity that undermines gender equality. Except among traditional circumcisers and some members of councils of elders, MMC and female providers were largely deemed acceptable. Conclusion: EIMC and MMC are slowly gaining acceptance, providing important tools to challenge adverse gender norms associated with TMC.

MP49-08 SHANGRING VERSUS THE MOGEN CLAMP FOR EARLY INFANT MALE CIRCUMCISION (EIMC): A COST-COMPARATIVE ANALYSIS IN KENYA, TANZANIA AND UGANDA

You have accessJournal of UrologyCME1 Apr 2023MP49-08 SHANGRING VERSUS THE MOGEN CLAMP FOR EARLY INFANT MALE CIRCUMCISION (EIMC): A COST-COMPARATIVE ANALYSIS IN KENYA, TANZANIA AND UGANDA Mary O. Strasser, Lina Posada, Nahid Punjani, Spyridon Basourakos, Godfrey Kigozi, Quentin Awori, Alice Christensen, Mark Barone, Karla Ballman, Marc Goldstein, Alvin Mushlin, Philip Li, and Richard K. Lee Mary O. StrasserMary O. Strasser More articles by this author , Lina PosadaLina Posada More articles by this author , Nahid PunjaniNahid Punjani More articles by this author , Spyridon BasourakosSpyridon Basourakos More articles by this author , Godfrey KigoziGodfrey Kigozi More articles by this author , Quentin AworiQuentin Awori More articles by this author , Alice ChristensenAlice Christensen More articles by this author , Mark BaroneMark Barone More articles by this author , Karla BallmanKarla Ballman More articles by this author , Marc GoldsteinMarc Goldstein More articles by this author , Alvin MushlinAlvin Mushlin More articles by this author , Philip LiPhilip Li More articles by this author , and Richard K. LeeRichard K. Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003297.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The World Health Organization (WHO) has recommended voluntary medical male circumcision (VMMC) as a prevention strategy for countries with low rates of circumcision and high rates of the heterosexually-transmitted human immunodeficiency virus (HIV). Early infant male circumcision (EIMC) is being considered due to its simplicity, rapid wound healing, and similar or more long-term benefits to adolescents and adults. However, data regarding the safety, efficacy, and cost of EIMC are limited. Thus, we sought to perform a comprehensive cost assessment of the ShangRing (SR) versus the standard of care (Mogen Clamp, MoC) as the EIMC device for future scale-up and a cost-effective HIV prevention strategy in this patient population. METHODS: As a secondary endpoint to an EIMC randomized controlled trial (RCT) of infants aged 0-60 days in Kenya, Tanzania , and Uganda, receiving SR versus MoC, utilization and cost data were analyzed. This included baseline facility costs, direct costs such as equipment, supply, and personnel costs, as well as indirect costs such as facility maintenance and capital cost for equipment. The Decision Makers Program Planning Tool (DMPPT) v1.0, developed by the USAID Health Policy Initiative in collaboration with UNAIDS, was utilized to perform a direct cost comparison of these two devices. This analysis tool derives a single unit cost of a procedure based on the baseline facility share, direct and indirect costs. All expenses adn costs related to this RCT are are reported in USD. RESULTS: A total of 1378 infant males underwent EIMC, of which 689 had SR , and 689 had MoC. No significant complications required additional cost or intervention at either study site. The overall cost of a single EIMC in Kenya, Uganda , and Tanzania were $61.30, $47.14 and $64.59, respectively for the SR ; and $56.38, $50.43, and $58.57, respectively, for the MoC. For both EIMC devices, the costs were mainly driven by direct costs. CONCLUSIONS: SR is a safe and low-cost alternative for EIMC in VMMC in Sub-Saharan Africa. Moreover, with scale-up utilizing lower-level personnel, the SR cost may be further reduced. Therefore, the SR is an attractive alternative for future EIMC initiatives in sub-Saharan Africa to further reduce the HIV burden in these regions. Source of Funding: The Bill and Melinda Gates Foundation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e680 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mary O. Strasser More articles by this author Lina Posada More articles by this author Nahid Punjani More articles by this author Spyridon Basourakos More articles by this author Godfrey Kigozi More articles by this author Quentin Awori More articles by this author Alice Christensen More articles by this author Mark Barone More articles by this author Karla Ballman More articles by this author Marc Goldstein More articles by this author Alvin Mushlin More articles by this author Philip Li More articles by this author Richard K. Lee More articles by this author Expand All Advertisement PDF downloadLoading ...

Infectious Disease Modelling of HIV Prevention Interventions: A Systematic Review and Narrative Synthesis of Compartmental Models

The HIV epidemic remains a major public health problem. Critical to transmission control are HIV prevention strategies with new interventions continuing to be developed. Mathematical models are important for understanding the potential impact of these interventions and supporting policy decisions. This systematic review aims to answer the following question: when a new HIV prevention intervention is being considered or designed, what information regarding it is necessary to include in a compartmental model to provide useful insights to policy makers? The primary objective of this review is therefore to assess suitability of current compartmental HIV prevention models for informing policy development. Articles published in EMBASE, Medline, Econlit, and Global Health were screened. Included studies were identified using permutations of (i) HIV, (ii) pre-exposure prophylaxis (PrEP), circumcision (both voluntary male circumcision [VMMC] and early-infant male circumcision [EIMC]), and vaccination, and (iii) modelling. Data extraction focused on study design, model structure, and intervention incorporation into models. Article quality was assessed using the TRACE (TRAnsparent and Comprehensive Ecological modelling documentation) criteria for mathematical models. Of 837 articles screened, 48 articles were included in the review, with 32 unique mathematical models identified. The substantial majority of studies included PrEP (83%), whilst fewer modelled circumcision (54%), and only a few focussed on vaccination (10%). Data evaluation, implementation verification, and model output corroboration were identified as areas of poorer model quality. Parameters commonly included in the mathematical models were intervention uptake and effectiveness, with additional intervention-specific common parameters identified. We identified key modelling gaps; critically, models insufficiently incorporate multiple interventions acting simultaneously. Additionally, population subgroups were generally poorly represented-with future models requiring improved incorporation of ethnicity and sexual risk group stratification-and many models contained inappropriate data in parameterisation which will affect output accuracy. This review identified gaps in compartmental models to date and suggests areas of improvement for models focusing on new prevention interventions. Resolution of such gaps within future models will ensure greater robustness and transparency, and enable more accurate assessment of the impact that new interventions may have, thereby providing more meaningful guidance to policy makers.

Can the ShangRing bring us closer to endorsing early infant male circumcision in sub-Saharan Africa?

Can the ShangRing bring us closer to endorsing early infant male circumcision in sub-Saharan Africa?

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

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. 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. gov, NCT03338699, and is complete. 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. 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. Bill & Melinda Gates Foundation.

Evidence-based circumcision policy for Australia.

The aim was (1) to perform an up-to-date systematic review of the male circumcision (MC) literature and (2) to determine the number of adverse medical conditions prevented by early MC in Australia. Searches of PubMed using “circumcision” with 39 keywords and bibliography searches yielded 278 publications meeting our inclusion criteria. Early MC provides immediate and lifetime benefits, including protection against: urinary tract infections, phimosis, inflammatory skin conditions, inferior penile hygiene, candidiasis, various STIs, and penile and prostate cancer. In female partners MC reduces risk of STIs and cervical cancer. A risk-benefit analysis found benefits exceeded procedural risks, which are predominantly minor, by approximately 200 to 1. It was estimated that more than 1 in 2 uncircumcised males will experience an adverse foreskin-related medical condition over their lifetime. An increase in early MC in Australia to mid-1950s prevalence of 85% from the current level of 18.75% would avoid 77,000 cases of infections and other adverse medical conditions over the lifetime for each annual birth cohort. Survey data, physiological measurements, and the anatomical location of penile sensory receptors responsible for sexual sensation indicate that MC has no detrimental effect on sexual function, sensitivity or pleasure. US studies found that early infant MC is cost saving. Evidence-based reviews by the AAP and CDC support early MC as a desirable public health measure. Although MC can be performed at any age, early MC maximizes benefits and minimises procedural risks. Parents should routinely be provided with accurate, up-to-date evidence-based information in an unbiased manner early in a pregnancy so that they have time to weigh benefits and risks of early MC and make an informed decision should they have a son. Parental choice should be respected. A well-trained competent practitioner is essential and local anaesthesia should be routinely used. Third party coverage of costs is advocated.

MP67-06 RESULTS OF A RANDOMIZED CONTROLLED TRIAL OF SHANGRING VERSUS MOGEN CLAMP IN EARLY INFANT MALE CIRCUMCISION IN SUB-SAHARAN AFRICA

You have accessJournal of UrologyGlobal Health/Humanitarian (MP67)1 Sep 2021MP67-06 RESULTS OF A RANDOMIZED CONTROLLED TRIAL OF SHANGRING VERSUS MOGEN CLAMP IN EARLY INFANT MALE CIRCUMCISION IN SUB-SAHARAN AFRICA Quincy Nang, Spyridon Basourakos, Nahid Punjani, Omar All Hussein Al Awamlh, Kaylee Ho, Karla Ballman, Mark Barone, Quentin Awori, Daniel Ouma, Alice Christensen, Godfrey Kigozi, Marc Goldstein, Philip Li, and Richard Lee Quincy NangQuincy Nang More articles by this author , Spyridon BasourakosSpyridon Basourakos More articles by this author , Nahid PunjaniNahid Punjani More articles by this author , Omar All Hussein Al AwamlhOmar All Hussein Al Awamlh More articles by this author , Kaylee HoKaylee Ho More articles by this author , Karla BallmanKarla Ballman More articles by this author , Mark BaroneMark Barone More articles by this author , Quentin AworiQuentin Awori More articles by this author , Daniel OumaDaniel Ouma More articles by this author , Alice ChristensenAlice Christensen More articles by this author , Godfrey KigoziGodfrey Kigozi More articles by this author , Marc GoldsteinMarc Goldstein More articles by this author , Philip LiPhilip Li More articles by this author , and Richard LeeRichard Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002028.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Early infant male circumcision (EIMC) is expected to help reduce HIV incidence and transmission given the compelling evidence in adults and adolescents. The ShangRing (SR) is the only World Health Organization prequalified circumcision device for males over 10 years requiring only topical peri-procedural anesthesia. We conducted the first large-scale randomized controlled trial in three sub-Saharan African countries comparing the safety and efficacy of the SR to current standard of care, the Mogen clamp (MoC) in early infants. METHODS: Healthy male infants from 11 sites in Kenya, Tanzania, and Uganda were equally randomized to EIMC with SR vs. MoC. Patients with congenital genitourinary anomalies, bleeding diathesis, or allergy to local anesthetics were excluded. Patients were followed for 42 days or until completion of healing. The primary endpoint was safety as defined by rates of adverse events. Secondary endpoints included procedural duration, pain (neonatal infant pain scale, NIPS), wound healing time, and parental satisfaction. RESULTS: A total of 1378 infant males were enrolled (SR: n=689, MoC: n=689). Patient groups were similar between devices, and within each country. The rates of adverse events were similar between the two groups (6.0% vs. 8.6%, p=0.08). No glandular injury (partial or total transection), severe wound infection, or hemorrhage were recorded. Post-operative mean NIPS scores in the SR and MC groups were 0.3±0.8 vs. 0.3±0.7 (p=0.29) respectively. All participants reached complete healing by post-operative day 42. No statistically significant differences were observed in supplemental local anesthetic rates (2.9% vs. 3%, p=1), procedural duration (mean 12.3±8.0 vs. 12.6±9.1 minutes, p=0.58), parental satisfaction with postoperative cosmesis (99.1% vs. 99.5%, p=0.60), and willingness to recommend circumcision (99.1% vs. 99.7%, p=0.22). CONCLUSIONS: EIMC with the SR is safe and does not significantly differ from the current standard of care. SR represents a unique opportunity to scale up EIMC services by implementing as a single-use device across all age ranges. Broad use of the SR, especially when targeted to males in early life, may further increase rates of circumcision in sub-Saharan Africa and subsequently lead to reductions in HIV transmission. Source of Funding: BMGF © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e511-e511 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Quincy Nang More articles by this author Spyridon Basourakos More articles by this author Nahid Punjani More articles by this author Omar All Hussein Al Awamlh More articles by this author Kaylee Ho More articles by this author Karla Ballman More articles by this author Mark Barone More articles by this author Quentin Awori More articles by this author Daniel Ouma More articles by this author Alice Christensen More articles by this author Godfrey Kigozi More articles by this author Marc Goldstein More articles by this author Philip Li More articles by this author Richard Lee More articles by this author Expand All Advertisement Loading ...

MP67-07 TASK-SHIFTING CAN BE SAFELY CONDUCTED IN EARLY INFANT MALE CIRCUMCISION IN SUB-SAHARAN AFRICA: EXAMPLE FROM THE SHANGRING VERSUS MOGEN CLAMP RANDOMIZED CONTROLLED TRIAL

INTRODUCTION AND OBJECTIVE:Early infant male circumcision (EIMC) efforts can help reduce the global burden of Human Immunodeficiency Virus (HIV). However, a shortage of highly trained providers has...

P1084 - Listening to the parents as key to early infant male circumcision efforts in fight against HIV: Perspectives of a contemporary cohort of legal adult representatives of infants enrolled in the ShangRing vs. mogen clamp trial

P1084 - Listening to the parents as key to early infant male circumcision efforts in fight against HIV: Perspectives of a contemporary cohort of legal adult representatives of infants enrolled in the ShangRing vs. mogen clamp trial

Uptake and outcomes of early infant male circumcision services in four counties in Western Kenya

Background: Early Infant Male Circumcision (EIMC) is part of sustainable HIV prevention strategies in Kenya. The goals of the national EIMC program are to circumcise at least 40% of all newborn male infants delivered at hospitals offering the service and keep the rate of moderate and adverse events below 2%.&#x0D; Objectives: To determine the proportion of early male infants (age less than 60 days) born at hospitals in four counties of western Kenya who got circumcised and document the prevalence of adverse events (AEs) among those circumcised.&#x0D; Methods: A retrospective descriptive study involving all records for EIMC from 1st March 2014 through 31st March 2018 in four counties of western Kenya. Data analysis was done using EXEL to document proportion of facilities offering EIMC and compare EIMC uptake and outcomes in the four counties against the national goals for the program.&#x0D; Results: A mean of 4.3% of total health facilities offer EIMC in the region. Siaya had the highest proportion of facilities offering EIMC while Migori had the lowest proportion. Uptake of EIMC was low at 17.4% for all male infants born, far less than the anticipated target of 40%. Average adverse event rates were 0.3%.&#x0D; Conclusion: EIMC uptake remains low in this region of Kenya due to small number of health facilities offering the service. The proportion of circumcised early male infants born at the target health facilities is below the national target of 40% even though the rate of adverse events among those circumcised is acceptable.&#x0D; Keywords: Adverse event; circumcision; early male infant; uptake; western Kenya.

Uptake and outcomes of early infant male circumcision services in four counties in Western Kenya.

Early Infant Male Circumcision (EIMC) is part of sustainable HIV prevention strategies in Kenya. The goals of the national EIMC program are to circumcise at least 40% of all newborn male infants delivered at hospitals offering the service and keep the rate of moderate and adverse events below 2%. To determine the proportion of early male infants (age less than 60 days) born at hospitals in four counties of western Kenya who got circumcised and document the prevalence of adverse events (AEs) among those circumcised. A retrospective descriptive study involving all records for EIMC from 1st March 2014 through 31st March 2018 in four counties of western Kenya. Data analysis was done using EXEL to document proportion of facilities offering EIMC and compare EIMC uptake and outcomes in the four counties against the national goals for the program. A mean of 4.3% of total health facilities offer EIMC in the region. Siaya had the highest proportion of facilities offering EIMC while Migori had the lowest proportion. Uptake of EIMC was low at 17.4% for all male infants born, far less than the anticipated target of 40%. Average adverse event rates were 0.3%. EIMC uptake remains low in this region of Kenya due to small number of health facilities offering the service. The proportion of circumcised early male infants born at the target health facilities is below the national target of 40% even though the rate of adverse events among those circumcised is acceptable.

Field evaluation of the safety, acceptability, and feasibility of early infant male circumcision using the AccuCirc device.

BackgroundAs 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.MethodsProcedures 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.ResultsOf 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.ConclusionsThis 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.

Acceptability and feasibility of early infant male circumcision for HIV prevention in Malawi.

BackgroundVoluntary medical male circumcision (VMMC) has been successfully implemented in 14 countries as an additional HIV prevention intervention. As VMMC programs mature in most countries, the focus is now on how to sustain the HIV prevention gains realised from VMMC. As part of preparations for the sustainability phase, countries are either piloting or preparing to pilot early infant male circumcision (EIMC). This qualitative study explored the acceptability and feasibility of EIMC in Malawi in order to inform pilot implementation.MethodsIn 2016, 23 focus group discussions were held across Malawi with participants from several ethnicities and religions/faiths. Additionally, 21 key informant interviews were held with traditional and religious leaders, traditional circumcisers (ngalibas), policy-makers, programme managers and health-care workers. Audio recordings were transcribed, translated into English (where necessary), and thematically coded using NVivo 10.ResultsDiscussions highlighted the socio-cultural significance of MC in Malawi. Knowledge or experience of EIMC was poor although acceptability was high among most ethnic/religious groups and key informants. Participants identified EIMC's comparative HIV benefits although a few health-care workers expressed scepticism. All participants said EIMC should be offered within a clinical setting. In addition to fathers, maternal uncles and traditional leaders were deemed key decision-makers. Potential barriers to EIMC included concerns about procedure safety as well as cultural considerations. Key informants felt it was feasible to offer EIMC in Malawi. Participants' recommendations, including phased implementation, engagement of traditional leaders, use of external mobilisers and initially reaching out to influential parents, will be taken into account when designing a pilot EIMC program.ConclusionsEIMC is potentially an acceptable and feasible HIV prevention intervention for most ethnic/religious groups in Malawi if wide-ranging, culturally appropriate demand-creation activities are developed, piloted, evaluated and appropriately implemented.

What device would be best for early infant male circumcision in east and southern Africa? Provider experiences and opinions with three different devices in Kenya.

Voluntary medical male circumcision (VMMC) reduces risk of HIV acquisition in heterosexual men by approximately 60%. As some countries approach targets for proportions of adolescents and adults circumcised, some are considering early infant male circumcision (EIMC) as a means to achieve sustainability of VMMC for long term reduction of HIV incidence. Evaluations of specialized devices for EIMC are important to provide programs with information required to make informed decisions about how to design safe, effective EIMC programs. We provide assessments by 11 providers with experience in Kenya employing all three of the devices most likely to be considered by various EIMC programs in east and Southern Africa. There was no one device that was seen to be clearly superior to the others. Each had its own advantages and disadvantages. Provider preferences were situation-specific. Most preferred the Mogen Clamp if they themselves were performing the procedure. However, most were concerned that not everyone will have the skills necessary for optimal safety. If someone else were circumcising their son, most would opt for the AccuCirc because of the risk of severing the glans when using the Mogen. A minority preferred the PrePex, but only if the baby received local anesthesia, not EMLA cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%), as presently prescribed by the manufacturer. In the context of a national EIMC program, all participants agreed that AccuCirc would be the device they would recommend due to protection of the glans from laceration and to the provision of a pre-assembled sterile kit that overcomes the need for additional supplies or autoclaving. All agreed that scaling up EIMC, integrating it with existing maternal child health services, will face significant challenges, not least of which is persuading already over-burdened providers to take on additional workload. These results will be useful to programmers considering introduction of EIMC services in sub-Saharan African settings.

Prevalence and Predictors of Uncircumcised, Kenyan Men's Desire for Circumcision for Their Infant Sons.

Men are key decision makers for their son's circumcision, so understanding their beliefs is important for the uptake of early infant male circumcision in countries in sub-Saharan Africa that have high HIV prevalence. We analyzed men's preferences for circumcising their sons using data from a population-representative survey of 1501 uncircumcised men aged 25-49years in western Kenya. Most men (59%) reported they would "definitely" want their son circumcised if a son was born to them within the next year. However, only 25% intended to become circumcised themselves. In multivariable Poisson regression models to estimate prevalence ratios, key predictors of the desire to circumcise their sons included knowledge that circumcision reduces HIV acquisition, having a supportive partner, discussing circumcision with the partner, altruism, and intention to be circumcised himself. Focusing on partner dynamics may have the greatest capacity to increase demand since 55% had not talked to their partner about circumcision.

Unpacking early infant male circumcision decision-making using qualitative findings from Zimbabwe

BackgroundEarly infant male circumcision (EIMC) has been identified as a key HIV prevention intervention. Exploring the decision-making process for adoption of EIMC for HIV prevention among parents and other key stakeholders is critical for designing effective demand creation interventions to maximize uptake, roll out and impact in preventing HIV. This paper describes key players, decisions and actions involved in the EIMC decision-making process.MethodsTwo complementary qualitative studies explored hypothetical and actual acceptability of EIMC in Zimbabwe. The first study (conducted 2010) explored hypothetical acceptability of EIMC among parents and wider family through focus group discussions (FGDs, n = 24). The follow-up study (conducted 2013) explored actual acceptability of EIMC among parents through twelve in-depth interviews (IDIs), four FGDs and short telephone interviews with additional parents (n = 95). Short statements from the telephone interviews were handwritten. FGDs and IDIs were audio-recorded, transcribed and translated into English. All data were thematically coded.ResultsStudy findings suggested that EIMC decision-making involved a discussion between the infant’s parents. Male and female participants of all age groups acknowledged that the father had the final say. However, discussions around EIMC uptake suggested that the infant’s mother could sometimes covertly influence the father's decision in the direction she favoured. Discussions also suggested that fathers who had undergone voluntary medical male circumcision were more likely to adopt EIMC for their sons, compared to their uncircumcised counterparts. Mothers-in-law/grandparents were reported to have considerable influence. Based on study findings, we describe key EIMC decision makers and attempt to illustrate alternative outcomes of their key actions and decisions around EIMC within the Zimbabwean context.ConclusionsThese complementary studies identified critical players, decisions and actions involved in the EIMC decision-making process. Findings on who influences decisions regarding EIMC in the Zimbabwean context highlighted the need for EIMC demand generation interventions to target fathers, mothers, grandmothers, other family members and the wider community.