<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="research-article" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">Gates Open Res</journal-id>
            <journal-title-group>
                <journal-title>Gates Open Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2572-4754</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/gatesopenres.15971.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Research Article</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Estimating the unit cost of voluntary medical male circumcision using surgical and device methods in integrated health settings in Kenya</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: 2 approved with reservations]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Omondi</surname>
                        <given-names>Rodgers</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <uri content-type="orcid">https://orcid.org/0000-0003-0666-0272</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Kioko</surname>
                        <given-names>Urbanus</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-4612-1233</uri>
                    <xref ref-type="aff" rid="a3">3</xref>
                    <xref ref-type="aff" rid="a4">4</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Juma</surname>
                        <given-names>Ambrose</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Serrem</surname>
                        <given-names>Kennedy</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Korir</surname>
                        <given-names>Julius</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <xref ref-type="aff" rid="a4">4</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Rotich</surname>
                        <given-names>Wesley</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a4">4</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Bitange</surname>
                        <given-names>Deborah</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Bhattacharjee</surname>
                        <given-names>Parinita</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0003-3277-7693</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                    <xref ref-type="aff" rid="a5">5</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Moses</surname>
                        <given-names>Stephen</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a5">5</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Health, Partners for Health and Development in Africa,, Nairobi, Nairobi, 40100, Kenya</aff>
                <aff id="a2">
                    <label>2</label>Ministry of health, National AIDS and STI Control Programme, Nairobi, Nairobi, Kenya</aff>
                <aff id="a3">
                    <label>3</label>University of Nairobi Kenya, Department of Economics and Development Studies, Nairobi, Nairobi, Kenya</aff>
                <aff id="a4">
                    <label>4</label>Ministry of health, Center for Economic and Social Research, Nairobi, Nairobi, Kenya</aff>
                <aff id="a5">
                    <label>5</label>University of Manitoba, Institute for Global Public Health, University of Manitoba, Winnipeg, Canada</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:rodgermoshi@gmail.com">rodgermoshi@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>21</day>
                <month>1</month>
                <year>2025</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2025</year>
            </pub-date>
            <volume>9</volume>
            <elocation-id>2</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>2</day>
                    <month>12</month>
                    <year>2024</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Omondi R et al.</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://gatesopenresearch.org/articles/9-2/pdf"/>
            <abstract>
                <sec>
                    <title>Background</title>
                    <p>Successful voluntary medical male circumcision (VMMC) programmes need to integrate various programme elements into health service delivery to optimize resources. We estimated the unit cost for the delivery of VMMC services in integrated health settings designed to provide a package of services, including education, risk reduction counselling, condom promotion, HIV testing and information on the VMMC procedures, in Kenya.</p>
                </sec>
                <sec>
                    <title>Methods</title>
                    <p>An ingredient costing approach was used to estimate the unit cost in 5 health facilities, using surgical and device methods in Homabay and Kisumu counties, western Kenya. Data were collected retrospectively by reviewing financial and asset records in the health facilities located in rural and urban settings, for the period 2017&#x2013;2018.</p>
                </sec>
                <sec>
                    <title>Results</title>
                    <p>The unit cost of delivering non-complicated VMMC procedures to infants aged 0-60 days was $14.05 (by device), to boys aged 10&#x2013;14 years was USD $19.35 (range $13.99-$22.54) by surgery, and to adolescent and adults over 14 years was $19.34 (range $13.84-$22.85) by surgery and was $20.5 by device. The overall unit cost for delivering VMMC services with moderate and mild complications to infants was $17.88 and $18.78 respectively; to adolescents aged 10&#x2013;14 years across all the sites were $23.33 and $22.18, respectively and to adolescents and adults above 14 years across all the sites were $25.31 and $22.31 respectively for surgical method and were $23.32 and $23.25 respectively for device method. The highest cost heads were related to direct cost heads related to direct staff cost, consumable drugs and supplies and non consumable supplies.</p>
                </sec>
                <sec>
                    <title>Conclusions</title>
                    <p>The average cost per VMMC using an integrated service model was much lower compared to results from previous costing studies which used a stand-alone delivery model. The provision of VMMC services within an integrated setting can be cost-saving.</p>
                </sec>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>VMMC</kwd>
                <kwd>Kenya</kwd>
                <kwd>Integration</kwd>
                <kwd>routine health services</kwd>
            </kwd-group>
            <funding-group>
                <award-group id="fund-1">
                    <funding-source> Gates Foundation</funding-source>
                    <award-id>[OPP1131428]</award-id>
                </award-group>
                <funding-statement>This work was supported by the Gates Foundation [OPP1131428]</funding-statement>
                <funding-statement>
                    <italic>The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.</italic>
                </funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec sec-type="intro">
            <title>Introduction</title>
            <p>Voluntary medical male circumcision (VMMC) as a public health intervention has enormous health benefits, including but not limited to the protection of men from urinary tract infections, HIV infection, HPV infection, syphilis, chancroid, penile carcinoma, prostate cancer, phimosis, thrush, and inflammatory dermatoses
                <sup>
                    <xref ref-type="bibr" rid="ref-1">1</xref>
                </sup>. The available evidence suggests that VMMC has the potential to reduce a man&#x2019;s risk of contracting heterosexually acquired HIV by 50% or more
                <sup>
                    <xref ref-type="bibr" rid="ref-2">2</xref>
                </sup>. It has also been shown to provide substantial protection to women from cervical cancer and chlamydial infection
                <sup>
                    <xref ref-type="bibr" rid="ref-3">3</xref>
                </sup>. Remarkable progress has been made in the scale up of VMMC programmes for HIV prevention globally, and particularly in 15 priority countries of eastern and southern Africa, where male circumcision is generally not practiced traditionally
                <sup>
                    <xref ref-type="bibr" rid="ref-4">4</xref>
                </sup>. It is estimated that from 2008&#x2013;2018, 23 million adolescents and men were reached by VMMC programmes worldwide, and nearly 50% (11 million) of VMMC procedures in these programmes were performed in the 15 priority countries of eastern and southern Africa
                <sup>
                    <xref ref-type="bibr" rid="ref-2">2</xref>
                </sup>.</p>
            <p>According to the global AIDS monitoring report 2019, more than 1.8 million adolescent males and men received VMMC services in Kenya since 2009, and this greatly contributed to the reduction observed in new HIV infections in the country at the population level
                <sup>
                    <xref ref-type="bibr" rid="ref-5">5</xref>
                </sup>. VMMC is therefore considered a very important component of HIV prevention strategies in settings where there are high HIV infection rates and traditionally low circumcision rates
                <sup>
                    <xref ref-type="bibr" rid="ref-6">6</xref>
                </sup>. Furthermore, it is cost-effective if provided to both adolescent boys and adult men
                <sup>
                    <xref ref-type="bibr" rid="ref-7">7</xref>&#x2013;
                    <xref ref-type="bibr" rid="ref-10">10</xref>
                </sup>. In addition, modelling studies in several African countries have shown that providing VMMC services to adolescent boys can have a greater cost-saving per HIV infection averted compared to circumcising only adult males
                <sup>
                    <xref ref-type="bibr" rid="ref-11">11</xref>&#x2013;
                    <xref ref-type="bibr" rid="ref-13">13</xref>
                </sup>.</p>
            <p>In Kenya, the Ministry of Health (MOH) made VMMC part of its national HIV prevention strategy in 2008, and since then the programme has been implemented in phases. The first phase of the VMMC programme, through 2013, succeeded in circumcising nearly 730,000 males out of the targeted 860,000, translating into 85% of the target. The second phase was launched in 2014, guided by the second VMMC strategy and operational plan (2014/15-2018/19). In this phase, the aims were to maintain the gains made in the first phase, to ensure that VMMC services were integrated into the health system, and to increase VMMC coverage to 95% of the target by 2019
                <sup>
                    <xref ref-type="bibr" rid="ref-6">6</xref>
                </sup>. In 2018, Kenya also developed a guideline to provide guidance to programme partners to integrate VMMC services into routine health services
                <sup>
                    <xref ref-type="bibr" rid="ref-14">14</xref>
                </sup>.</p>
            <p>Costing is a critical activity in guiding the integration of services. Previous studies conducted in Kenya estimated the unit cost of VMMC services using stand-alone service delivery models, i.e. at public health facilities, and through outreach and mobile service delivery, and found that the cost per VMMC service ranged from US $38.62- $44.24
                <sup>
                    <xref ref-type="bibr" rid="ref-15">15</xref>
                </sup>. This compares favorably with the unit costs in similar settings in Africa, which range from US $35-$50
                <sup>
                    <xref ref-type="bibr" rid="ref-16">16</xref>,
                    <xref ref-type="bibr" rid="ref-17">17</xref>
                </sup>. However, in the national VMMC strategy launched in 2014, Kenya encouraged implementing partners to pilot the provision of VMMC services through integration into routine services. In the context of Kenya&#x2019;s plan to integrate VMMC services into routine health services
                <sup>
                    <xref ref-type="bibr" rid="ref-14">14</xref>
                </sup>, we conducted this costing study to estimate the unit cost of delivering VMMC services, both for surgical and device procedures, through integration into routine health services in western Kenya.</p>
        </sec>
        <sec sec-type="methods">
            <title>Methods</title>
            <sec>
                <title>Programme description</title>
                <p>The provision of VMMC services at the facilities in this study was supported by the United States Agency for International Development (USAID) under the PEPFAR programme
                    <sup>
                        <xref ref-type="bibr" rid="ref-18">18</xref>
                    </sup>. These services were provided in collaboration with the Ministry of Health at the national and county levels, in accordance with the National Strategy for Voluntary Male Medical Circumcision. The implementing partners identified Ministry of Health facilities where VMMC services were integrated into the routine primary health care services provided at these facilities. The integrated VMMC services were designed to provide a package of services, including education on the benefits of VMMC, risk reduction counselling, condom promotion, HIV testing services, and information on the VMMC procedures and follow- up. VMMC services were provided by staff comprising a clinical officer, a surgical assistant, a counsellor, and an infection prevention officer.</p>
            </sec>
            <sec>
                <title>Study design</title>
                <p>We conducted this study in 2019, using data collected from 2017&#x2013;2018. The study employed an ingredient costing approach to estimate the unit cost of providing VMMC to one client at each site. All of the inputs were listed and their contribution to the overall cost was then quantified. Unit costs were adjusted for costs associated with complications. Our analysis adopted the health provider perspective.</p>
            </sec>
            <sec>
                <title>Site selection and sample size</title>
                <p>Five facilities were purposively selected to participate in the costing study, representing urban and rural locations. Rachuonyo Health Centre and Kendu Health Centre were in Homabay county, and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH), Chemelil Sugar Health Centre and Mashambani Health Centre were in Kisumu county. The facilities included in the study consisted of 4 public health facilities and one private health facility: JOOTRH is a teaching and referral hospital located in an urban area; Mashambani Health Centre and Chemelil Sugar Health Centre are two rural health centres; and Rachuonyo Health Centre and Kendu Bay Health Centre are two sub-county hospitals located in urban settings. Chemelil Sugar Health Centre is the only private health facility, while the other four are public health facilities.</p>
            </sec>
            <sec>
                <title>Data collection procedures</title>
                <p>Data collection tools used in this study were adapted from other costing studies used to estimate VMMC costs in Kenya and Tanzania in 2010 and 2014
                    <sup>
                        <xref ref-type="bibr" rid="ref-19">19</xref>,
                        <xref ref-type="bibr" rid="ref-20">20</xref>
                    </sup>. These tools were then reviewed to suit the needs of the current study. Cost data from facilities were collected retrospectively to cover 12-months of steady resource utilisation by the project, from July 2017 to June 2018. Before the start of data collection, staff from the VMMC Technical Support Unit (TSU), which is embedded within NASCOP, sensitised the implementing partners and service providers in the selected study sites. Data collectors were then trained on the tools and data collection procedures. Semi-structured data collection tools (questionnaires) were used to collect cost data from health managers or representatives, and other personnel who were directly involved in performing surgical and device procedures at the health facilities. Staff costs and other relevant information were obtained from the personnel registers or staff rosters, where applicable. In addition, information on the time taken by each staff member on any VMMC-related activity was obtained by conducting individual interviews with the staff. Staff were categorised as either direct or indirect staff: direct staff included members of the surgical team, such as clinical officers, nurses, counsellors, laboratory technicians, nurse assistants and hygiene officers. Support staff were considered as indirect staff members. The cost and quantity of each type of medicine and consumable used were obtained from the health facility pharmacy. For price information which was not available at the facility, reference was made to the most recent Kenya Medical Supplies Agency (KEMSA) price list. Cost data on capital items such as furniture, computers and equipment were obtained by reviewing the facility inventory and asset registers for each department involved in VMMC programme-related activities. Costs for office supplies and utilities were collected by reviewing the facility accounting records. Data on general services utilisation were obtained from inpatient and outpatient registers. Data collected included the number of inpatient admissions, the number of outpatients, and the number of VMMC procedures delivered using surgical and device procedures.</p>
            </sec>
            <sec>
                <title>Data analysis</title>
                <p>Data from each site was entered into an MS Excel spreadsheet, cleaned, and underwent preliminary analysis. All entered data were checked and validated, and in cases where inconsistencies were detected, additional clarification was sought from the key informants. The cost items were categorised into capital and recurrent resource costs.  The total cost of programme implementation at each site was calculated by summing up the total cost of capital and recurrent cost items. The cost per VMMC procedure was determined by dividing the total cost by the number of VMMC clients per facility. The unit costs for VMMC procedures with and without complications were then estimated separately, using an Excel costing framework. The research team initially estimated the unit cost for normal VMMC procedures using both the surgical and device methods, and then adjusted them for the cost of procedures associated with mild and moderate complications. VMMC services were integrated into existing services in both public and private health facilities, at all sites, so the costs of infrastructure development were not included in our estimates. A step-down procedure was used to allocate costs to various cost centres. Overhead costs such as equipment repairs, utilities, transport, maintenance and support costs (e.g. management and field supervision) were allocated to different cost centres based on the ratio of VMMC outpatient visits (work load) to total facility outpatient visits. The contribution of staff to VMMC activities was estimated based on time that each staff member spent on VMMC-related work at the facility and programme level. The unit costs for procedures with mild and moderate complications were estimated separately for routine surgical procedures and device methods, for adolescents aged 10&#x2013;14 years, adolescents and adults above 14 years of age, and infants aged 0&#x2013;60 days, and for public and private health facilities.</p>
            </sec>
        </sec>
        <sec>
            <title>Ethical approval</title>
            <p>Ethical approval for secondary analysis of the study data was obtained from the AMREF &#x2013; Ethical and Scientific Review Committee (AMREF-ESRC P1631-2024) on April 19
                <sup>th</sup> 2024. The data for the study was extracted from routine project documents related to budgets and expenditure. The study did not include any patient data. The financial and asset records were accessed from the offices of implementing partners in the study sites after detailed orientation to the programme and finance team on the objectives of the study. The implementing partners identified a team member from their programme and finance team to work with the study data collectors. The data used in the study cannot be linked to any specific individual.</p>
        </sec>
        <sec sec-type="results">
            <title>Results</title>
            <sec>
                <title>Number of non-complicated VMMC procedures delivered using surgical and device methods</title>
                <p>
                    <xref ref-type="table" rid="T1">Table 1</xref> summarises the number of VMMC procedures performed by facility, procedure and age category, during the 2017&#x2013;2018 study period. A total of 5,385 VMMCs were performed at all five sites. Eighty-five percent of VMMCs were performed in public facilities, while 15% were performed in the one private facility included in the study. The majority of VMMC procedures (61%) were performed among adolescents aged 10&#x2013;14 years, all using the surgical forceps guided method. Twenty-nine percent of VMMCs were performed among adolescents and adults over 14 years, with 93% using the surgical method, and only 7% using a Mogen clamp device. JOOTRH delivered the highest number of VMMCs for those in the 10&#x2013;14-year age category, while Chemelil delivered the highest number for those over 14 years of age. JOOTRH was the only facility that provided infant circumcision, using the device method.</p>
                <table-wrap id="T1" orientation="portrait" position="anchor">
                    <label>Table 1. </label>
                    <caption>
                        <title>Number of VMMCs performed by study site, age and delivery method.</title>
                    </caption>
                    <table content-type="article-table" frame="hsides">
                        <thead>
                            <tr>
                                <th colspan="1" rowspan="1"/>
                                <th align="left" colspan="2" rowspan="1" valign="top">0&#x2013;60 days</th>
                                <th align="left" colspan="2" rowspan="1" valign="top">10&#x2013;14 Years</th>
                                <th align="left" colspan="2" rowspan="1" valign="top">Above 14 Years</th>
                                <th align="center" colspan="1" rowspan="1" valign="top"/>
                            </tr>
                            <tr>
                                <th align="left" colspan="1" rowspan="1" valign="top">Facility Name</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Surgical
                                    <break/>Method</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Device
                                    <break/>Method</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Surgical
                                    <break/>Method</th>
                                <th align="left" colspan="1" rowspan="1" valign="top"> Device
                                    <break/>Method</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Surgical
                                    <break/>Method</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Device
                                    <break/>Method</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Total</th>
                            </tr>
                        </thead>
                        <tbody>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Chemelil </td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">106</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">723</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">829</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">JOOTRH</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">412</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">1,766</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">341</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">116</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">2,635</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Kendu Bay </td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">685</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">206</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">891</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Mashambani</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">180</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">61</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">241</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Rachuonyo </td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">558</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">231</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">789</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Total</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"> </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">412</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">3,295</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"> </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">1,562 </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">116</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">5,385</td>
                            </tr>
                        </tbody>
                    </table>
                </table-wrap>
            </sec>
            <sec>
                <title>Unit cost for the delivery of non-complicated VMMC procedures</title>
                <p>
                    <xref ref-type="table" rid="T2">Table 2</xref> shows the unit cost for the delivery of non-complicated VMMC procedures by facility, procedure and age. Overall, the unit cost of delivering non-complicated VMMC procedures to infants aged 0&#x2013;60 days was $14.05 (by device), to boys aged 10&#x2013;14 years it was USD $19.35 (range $13.99-$22.54) by surgery, and to adolescents and adults over 14 years was $19.34 (range $13.84-$22.85) by surgery and was $20.5 by device. Devices were only used in JOOTRH because it has the capacity and the trained staff to use devices. There was no marked difference in the unit cost for the provision of procedures between boys aged 10&#x2013;14 years, and adolescents and adults aged 14 years and above through the surgery method.</p>
                <table-wrap id="T2" orientation="portrait" position="anchor">
                    <label>Table 2. </label>
                    <caption>
                        <title>Unit cost for the delivery of non- complicated VMMC by site, age and delivery method.</title>
                    </caption>
                    <table content-type="article-table" frame="hsides">
                        <thead>
                            <tr>
                                <th colspan="1" rowspan="1"/>
                                <th align="left" colspan="2" rowspan="1" valign="top">
                                    <italic toggle="yes">0&#x2013;60 days</italic>
                                </th>
                                <th align="left" colspan="2" rowspan="1" valign="top">
                                    <italic toggle="yes">10&#x2013;14 days</italic>
                                </th>
                                <th align="left" colspan="2" rowspan="1" valign="top">
                                    <italic toggle="yes">Above 14 Years</italic>
                                </th>
                            </tr>
                            <tr>
                                <th align="left" colspan="1" rowspan="1" valign="top">
                                    <italic toggle="yes">Facility Name</italic>
                                </th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Surgical</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Device</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Surgical</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Device</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Surgical</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Device</th>
                            </tr>
                        </thead>
                        <tbody>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Chemelil</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">22.38</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">21.36</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">&#x00a0;</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">JOOTRH</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">14.05</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">22.54</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">22.85</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">20.50</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Kendu Bay</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">21.31</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">22.02</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">&#x00a0;</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Mashambani</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">16.56</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">16.63</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">&#x00a0;</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Rachuonyo</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">13.99</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">13.84</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">&#x00a0;</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Overall unit cost</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">14.05</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">19.35</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">19.34</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">20.5</td>
                            </tr>
                        </tbody>
                    </table>
                </table-wrap>
                <p>The main cost drivers for delivering non-complicated VMMC to boys aged 10&#x2013;14 years, and to adolescents and adults aged over 14 years, across all study sites, were direct staff costs, medical and non-medical supplies, and utilities and overhead costs. Direct costs accounted for more than 60% of the total delivery costs per non-complicated VMMC, with the lowest cost at $6.75 in Rachuonyo and the highest cost at $15.5 in Chemelil health centre. There was no marked variation in the unit cost for delivering non-complicated VMMC between the 10&#x2013;14 year and over 14-year age categories (see Table 4 Extended data).</p>
                <p>For the delivery of VMMC services using the device method, the main cost drivers were consumable and drug supplies, utilities and overheads, and direct staff costs, with direct and indirect costs accounting for about 57% and 43% of the delivery costs respectively. Utility and overhead costs contributed nearly 36% of the total delivery cost. Among infants, the costs were higher due to the small number of VMMCs performed over a large fixed cost outlay, and in only one health facility (JOOTRH) (Table 5 Extended data).</p>
            </sec>
            <sec>
                <title>Unit cost for the delivery of VMMC with moderate and mild complications using surgical and device methods</title>
                <p>The overall unit cost for delivering VMMC services with moderate and mild complications to infants was $17.88 and $18.78 respectively. The unit costs for delivering VMMC services with moderate and mild complications to adolescents aged 10&#x2013;14 years across all the sites were $23.33 and $22.18, respectively. The unit costs for delivering VMMC services using the surgical method with moderate and mild complications to adolescents and adults above 14 years across all the sites were $25.31 and $22.31 respectively and with a device were $23.32 and $23.25 respectively. The cost per VMMC with moderate and mild complications for adolescents aged 10&#x2013;14 years was lowest in Rachuonyo Sub-county hospital and highest in Chemelil sugar health centre (See 
                    <xref ref-type="table" rid="T3">Table 3</xref>).</p>
                <table-wrap id="T3" orientation="portrait" position="anchor">
                    <label>Table 3. </label>
                    <caption>
                        <title>Unit cost for the delivery of VMMC by Site, complication and Age using surgical and device methods.</title>
                    </caption>
                    <table content-type="article-table" frame="hsides">
                        <thead>
                            <tr>
                                <th colspan="1" rowspan="1"/>
                                <th align="left" colspan="2" rowspan="1" valign="top">0&#x2013;60 days</th>
                                <th align="left" colspan="2" rowspan="1" valign="top">10&#x2013;14 days</th>
                                <th align="left" colspan="4" rowspan="1" valign="top">Above 14 Years</th>
                            </tr>
                            <tr>
                                <th colspan="1" rowspan="1"/>
                                <th colspan="1" rowspan="1"/>
                                <th colspan="1" rowspan="1"/>
                                <th colspan="1" rowspan="1"/>
                                <th colspan="1" rowspan="1"/>
                                <th align="left" colspan="2" rowspan="1" valign="top">Surgical</th>
                                <th align="left" colspan="2" rowspan="1" valign="top">Device</th>
                            </tr>
                            <tr>
                                <th align="left" colspan="1" rowspan="1" valign="top">Facility</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">moderate</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">mild</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">Moderate</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">mild</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">moderate</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">mild</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">moderate</th>
                                <th align="left" colspan="1" rowspan="1" valign="top">mild</th>
                            </tr>
                        </thead>
                        <tbody>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Chemelil</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">27.26</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">26.99</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">28.15</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">25.88</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">&#x00a0;</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">JOOTRH</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">17.87
                                    <sup>
                                        <xref ref-type="other" rid="TFN1">a</xref>
                                    </sup>
                                </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">18.78
                                    <sup>
                                        <xref ref-type="other" rid="TFN1">a</xref>
                                    </sup>
                                </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">25.91</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">25.24</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">27.87</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">26.28</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">23.30
                                    <sup>
                                        <xref ref-type="other" rid="TFN1">a</xref>
                                    </sup>
                                </td>
                                <td align="left" colspan="1" rowspan="1" valign="top">23.35
                                    <sup>
                                        <xref ref-type="other" rid="TFN1">a</xref>
                                    </sup>
                                </td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Kendu Bay</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">24.61</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">24.80</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">31.72</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">25.58</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">&#x00a0;</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Mashambani</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">20.05</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">17.75</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">20.12</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">17.82</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">&#x00a0;</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Rachuonyo</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">18.84</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">16.13</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">18.68</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">15.98</td>
                                <td align="left" colspan="1" rowspan="1" valign="top"/>
                                <td align="left" colspan="1" rowspan="1" valign="top">&#x00a0;</td>
                            </tr>
                            <tr>
                                <td align="left" colspan="1" rowspan="1" valign="top">Overall unit cost</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">17.88</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">18.78</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">23.33</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">22.18</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">25.31</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">22.31</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">23.32</td>
                                <td align="left" colspan="1" rowspan="1" valign="top">23.35</td>
                            </tr>
                        </tbody>
                    </table>
                    <table-wrap-foot>
                        <fn>
                            <p id="TFN1">
                                <sup>a</sup> Device method was only used in JOOTRH and for ages 0&#x2013;60 days and over 14 years as indicated.</p>
                        </fn>
                    </table-wrap-foot>
                </table-wrap>
                <p>The main cost drivers for the delivery of VMMC with complications (both moderate and mild) across the five sites were the drug consumables and supplies, utilities and overheads, and direct staff costs. (see Table 6 Extended data). It was slightly more expensive to deliver VMMC with moderate complications compared to VMMC with mild complications for adolescents and adults 14years and above. The direct costs of delivering VMMC with moderate complications were $24.4 higher than delivering VMMC with mild complications. </p>
            </sec>
        </sec>
        <sec sec-type="discussion">
            <title>Discussion</title>
            <p>Our findings show that the unit cost of performing non-complicated VMMCs using a surgical procedure for boys aged 10&#x2013;14 years was $19.35; and ranged from $13.99 to $22.54 across the facilities. Using a device, the cost for the delivery of VMMC with no complications for infants aged 0&#x2013;60 days was $14.05, and the cost per VMMC with no complications for boys and adults over 14 years of age was $20.50. The variation in the unit cost observed across the facilities could have been driven by the volume of VMMCs performed at each site. However, Rachuonyo sub-county hospital, even though it had the fourth fewest number of VMMCs, was able to keep its unit cost lower compared to other facilities.</p>
            <p>The unit cost for the delivery of VMMC in our study was lower compared to that of similar studies done in Kenya. Previous studies estimated the cost per VMMC service delivered through a stand-alone model (at health facilities) at $38.62 to $108
                <sup>
                    <xref ref-type="bibr" rid="ref-9">9</xref>,
                    <xref ref-type="bibr" rid="ref-19">19</xref>
                </sup>, while our study, which estimated the cost per VMMC delivered using an integrated service model was $19.35. The lower unit cost may reflect increased efficiency in the use of resources when VMMC services are integrated into the routine services provided by a health facility. A modelling study designed to evaluate three models of circumcision service delivery in western Kenya (static, mobile and mixed)
                <sup>
                    <xref ref-type="bibr" rid="ref-21">21</xref>
                </sup>, found that the unit cost of providing circumcision using static and mobile models as more expensive than the mixed model, and all were more costly compared to the unit prices obtained in our study.</p>
            <p>Direct staff costs, and utilities and overhead costs were the main cost drivers in the delivery of VMMC services in our study. In the only private health centre (Chemelil), the unit personnel cost was higher compared to other sites. The difference can be attributed to the difference in staff salaries and the composition of the surgical team between this site and the public sites. These findings are consistent with results of other costing studies conducted in Kenya and in other settings, which reported staff costs to be the main cost driver in the provision of public health interventions (Dandona 
                <italic toggle="yes">et al.</italic>, 2005; Galarraga, Shah, Wilson-Barthes, Ayuku, &amp; Braitstein, 2018; Kioko, 2010).</p>
            <p>There was also a marked difference in the direct costs of delivering VMMC services with moderate complications among adolescents and adults aged over 14 years. This may be due to the high number of complications among the older age category. Evidence available from other studies which have assessed post-operative complications or adverse events (AEs) among adults, reported that complications appear to be higher in older men compared to younger ones
                <sup>
                    <xref ref-type="bibr" rid="ref-22">22</xref>&#x2013;
                    <xref ref-type="bibr" rid="ref-24">24</xref>
                </sup>.</p>
        </sec>
        <sec sec-type="conclusions">
            <title>Conclusion</title>
            <p>This study has added more evidence to the limited knowledge about the cost of delivering VMMC services in integrated settings for infants aged 0&#x2013;60 days, adolescents aged 10&#x2013;14 years, and adolescent boys and adults above 14 years. The average cost per VMMC using the surgical procedure or the device method is much lower compared to results from previous costing studies. Previous studies done in Kenya estimated the cost per VMMC service delivered through a stand- alone model (at health facilities) at $38.62 and $35
                <sup>
                    <xref ref-type="bibr" rid="ref-15">15</xref>&#x2013;
                    <xref ref-type="bibr" rid="ref-17">17</xref>
                </sup>, while our study which has estimated the cost per VMMC delivered using an integrated service model, is $19.35. Personnel, medical supplies, utilities and overhead costs were some of the key cost drivers in VMMC service provision in all of the sites surveyed, and staff costs were lower in a public facility compared to a private health facility. The provision of VMMC services in an integrated setting can be cost-saving and an efficient way of utilising scarce health resources.</p>
        </sec>
        <sec>
            <title>Ethical approval</title>
            <p>Ethical approval for secondary analysis of the study data was obtained from the AMREF &#x2013; Ethical and Scientific Review Committee (AMREF-ESRC P1631-2024) on April 19
                <sup>th</sup> 2024.</p>
        </sec>
    </body>
    <back>
        <sec sec-type="data-availability">
            <title>Data availability</title>
            <p>Harvard Dataverse: Estimating the unit cost of voluntary medical male circumcision using surgical and device methods in integrated health settings in Kenya, 
                <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.7910/DVN/XWAQXR">https://doi.org/10.7910/DVN/XWAQXR</ext-link>
                <sup>
                    <xref ref-type="bibr" rid="ref-25">25</xref>
                </sup>
            </p>
            <p> This project contains the following underlying data:</p>
            <list list-type="bullet">
                <list-item>
                    <p>Financial data.xlsx</p>
                </list-item>
            </list>
            <p>Data are available under the terms of the 
                <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">Creative Commons Zero &#x201c;No rights reserved&#x201d; data waiver</ext-link> (CC0 1.0 Public domain dedication).</p>
            <sec>
                <title>Extended data</title>
                <p>Harvard Dataverse: Estimating the unit cost of voluntary medical male circumcision using surgical and device methods in integrated health settings in Kenya, 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.7910/DVN/XWAQXR">https://doi.org/10.7910/DVN/XWAQXR</ext-link>
                    <sup>
                        <xref ref-type="bibr" rid="ref-25">25</xref>
                    </sup>
                </p>
                <p>This project contains the following data:</p>
                <list list-type="bullet">
                    <list-item>
                        <p>
                            <ext-link ext-link-type="uri" xlink:href="https://dataverse.harvard.edu/file.xhtml?fileId=10595384&amp;version=3.0">Extended data, Tables 4, 5 and 6.docx</ext-link> </p>
                    </list-item>
                    <list-item>
                        <p>MC Costing Facility tool- Facility A CHE.xlsx</p>
                    </list-item>
                    <list-item>
                        <p>MC Costing Facility tool- Facility C KEN.xlsx</p>
                    </list-item>
                    <list-item>
                        <p>MC Costing Facility tool- Facility D MAS.xlsx</p>
                    </list-item>
                    <list-item>
                        <p>MC Costing Facility tool-Facility B JOO.xlsx</p>
                    </list-item>
                    <list-item>
                        <p>MC Costing Facility tool-Facility E RAC.xlsx</p>
                    </list-item>
                </list>
                <p>Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">Creative Commons Zero &#x201c;No rights reserved&#x201d; data waiver</ext-link> (CC0 1.0 Public domain dedication).</p>
                <p>Co Author, Urbanus Kioko: 
                    <email xlink:href="mailto:urbanusmutukukioko@gmail.com">urbanusmutukukioko@gmail.com</email> will be able to facilitate any other data related requests.</p>
            </sec>
        </sec>
        <sec>
            <title>Contributions</title>
            <p>RO wrote the paper with contributions from UK, PB and SM. UK, KS, AJ and PB have been involved in the design of the study. JK and WR were involved in data collection, analysis and report writing. DB was involved in analysis and review of the paper. All co authors reviewed the paper.</p>
        </sec>
        <ack>
            <title>Acknowledgements</title>
            <p>This study was undertaken through a productive collaboration among the county departments of health in Kisumu and Homabay counties, the Kenyan National Ministry of Health, APHIA Ziwani, International Centre for AIDS Program (ICAP), and facility managers in the study sites involved. We also wish to thank the facility team. We would like to thank Ms. Sharon Korir and Mr. Ken Metho, who participated in the data collection and acted as data entry clerks. </p>
        </ack>
        <ref-list>
            <ref id="ref-1">
                <label>1</label>
                <mixed-citation publication-type="journal">
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                    <pub-id pub-id-type="doi">10.1186/1471-2490-10-2</pub-id>
                    <pub-id pub-id-type="pmcid">2835667</pub-id>
                </mixed-citation>
            </ref>
            <ref id="ref-25">
                <label>25</label>
                <mixed-citation publication-type="journal">
                    <person-group person-group-type="author">

                        <name name-style="western">
                            <surname>Bhattacharjee</surname>
                            <given-names>P</given-names>
                        </name>
</person-group>:
                    <article-title>Replication Data for: Estimating the unit cost of voluntary medical male circumcision using surgical and device methods in integrated health settings in Kenya</article-title>. Harvard Dataverse, V2,<year> 2023</year>.
                    <ext-link ext-link-type="uri" xlink:href="http://www.doi.org/10.7910/DVN/XWAQXR">http://www.doi.org/10.7910/DVN/XWAQXR</ext-link>
                </mixed-citation>
            </ref>
        </ref-list>
    </back>
    <sub-article article-type="reviewer-report" id="report39415">
        <front-stub>
            <article-id pub-id-type="doi">10.21956/gatesopenres.17330.r39415</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Saronga</surname>
                        <given-names>Happiness P</given-names>
                    </name>
                    <xref ref-type="aff" rid="r39415a1">1</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-1946-4855</uri>
                </contrib>
                <aff id="r39415a1">
                    <label>1</label>Muhimbili University of Healthand Allied Sciences, Dar es Salaam, Tanzania</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>26</day>
                <month>2</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Saronga HP</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport39415" related-article-type="peer-reviewed-article" xlink:href="10.12688/gatesopenres.15971.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>Introduction 
                <list list-type="order">
                    <list-item>
                        <p>Add more references to support the statement &#x201c;Previous studies conducted in Kenya estimated the unit cost of VMMC services using stand-alone service delivery models, i.e. at public health facilities, and through outreach and mobile service delivery, and found that the cost per&#x2026;&#x2026;..&#x201d;</p>
                    </list-item>
                </list> Program description 
                <list list-type="order">
                    <list-item>
                        <p>Describe surgical vs device procedures as well. What are they and how are they performed? These details will help the reader to understand the study more.</p>
                    </list-item>
                    <list-item>
                        <p>What kind of risk reduction is covered in &#x201c;risk reduction counselling&#x201d;? HIV?</p>
                    </list-item>
                </list> Study design 
                <list list-type="order">
                    <list-item>
                        <p>Which sites are you referring to? The reader does not know them at this point.</p>
                    </list-item>
                    <list-item>
                        <p>Study design is missing, we only have costing approach there.</p>
                    </list-item>
                    <list-item>
                        <p>Unit costs were adjusted for costs associated with complications- this requires more explanation of what complication, how and why?</p>
                    </list-item>
                    <list-item>
                        <p>Ingredients approach needs more description for the reader to understand it for non-health economists.</p>
                    </list-item>
                </list> Sample selection 
                <list list-type="order">
                    <list-item>
                        <p>May be more informative to say why the specific health facilities were sampled, any specific reasons apart from location?</p>
                    </list-item>
                </list> Data analysis 
                <list list-type="order">
                    <list-item>
                        <p>Need to detail step-down costing process</p>
                    </list-item>
                    <list-item>
                        <p>Were capital cost annuitized? How?</p>
                    </list-item>
                    <list-item>
                        <p>Specify which items were categorized as capital and which recurrent costs?</p>
                    </list-item>
                    <list-item>
                        <p>Can you detail the excel framework used to calculate unit cost with and without complications.</p>
                    </list-item>
                    <list-item>
                        <p>It looks like unit cost of VMMC for ages &gt;60 days to &lt;10 years were not estimated, why?</p>
                    </list-item>
                </list> Ethical approval 
                <list list-type="order">
                    <list-item>
                        <p>You had mentioned that the study was conducted in 2019, yet ethical clearance was obtained in 2024, this is such a big discrepancy.</p>
                    </list-item>
                    <list-item>
                        <p>Some of descriptions in ethical approval should be moved to data collection process section. This section should only give details about ethical approval, permissions to conduct study on health facilities or extract information from implementing partners, and privacy and confidentiality of data.</p>
                    </list-item>
                </list> Results 
                <list list-type="order">
                    <list-item>
                        <p>Table 1- I think it would make sense also to present complicated cases.</p>
                    </list-item>
                    <list-item>
                        <p>Tables- indicate currency for the cost</p>
                    </list-item>
                    <list-item>
                        <p>On Extended data Table 4, 5,6 - it would make more sense if cost were categorized into capital and recurrent cost OR Fixed and variable cost. This is because indirect cost in &#x201c;costing&#x201d; may mean productivity losses.</p>
                    </list-item>
                    <list-item>
                        <p>Check for appropriate labelling of age categories on table 2 and 3- days vs years.</p>
                    </list-item>
                </list> Discussion 
                <list list-type="order">
                    <list-item>
                        <p>I think it would make sense to use the word performing VMMC rather that delivering VMMC throughout the manuscript.</p>
                    </list-item>
                    <list-item>
                        <p>Use consistent citation style throughout.</p>
                    </list-item>
                    <list-item>
                        <p>What about a discussion on comparison of unit cost of performing uncomplicated vs complicated VMMC?</p>
                    </list-item>
                </list> Conclusion 
                <list list-type="order">
                    <list-item>
                        <p>The following statement should be shifted to a suitable place in the discussion &#x201c;previous studies done in Kenya estimated the cost per VMMC service delivered through a stand- alone model (at health facilities) at $38.62 and $35
                            <sup>
                                <ext-link ext-link-type="uri" xlink:href="https://gatesopenresearch.org/articles/9-2/v1#ref-15">15</ext-link>&#x2013;
                                <ext-link ext-link-type="uri" xlink:href="https://gatesopenresearch.org/articles/9-2/v1#ref-17">17</ext-link>
                            </sup>, while our study which has estimated the cost per VMMC delivered using an integrated service model, is $19.35&#x201d;</p>
                    </list-item>
                    <list-item>
                        <p>What do you conclude on the cost of complicated vs uncomplicated VMMC?</p>
                    </list-item>
                </list>
            </p>
            <p>Is the work clearly and accurately presented and does it cite the current literature?</p>
            <p>Yes</p>
            <p>If applicable, is the statistical analysis and its interpretation appropriate?</p>
            <p>Yes</p>
            <p>Are all the source data underlying the results available to ensure full reproducibility?</p>
            <p>Yes</p>
            <p>Is the study design appropriate and is the work technically sound?</p>
            <p>Yes</p>
            <p>Are the conclusions drawn adequately supported by the results?</p>
            <p>Yes</p>
            <p>Are sufficient details of methods and analysis provided to allow replication by others?</p>
            <p>Partly</p>
            <p>Reviewer Expertise:</p>
            <p>health economics</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.</p>
        </body>
    </sub-article>
    <sub-article article-type="reviewer-report" id="report39413">
        <front-stub>
            <article-id pub-id-type="doi">10.21956/gatesopenres.17330.r39413</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Morris</surname>
                        <given-names>Brian J</given-names>
                    </name>
                    <xref ref-type="aff" rid="r39413a1">1</xref>
                    <role>Referee</role>
                </contrib>
                <aff id="r39413a1">
                    <label>1</label>The University of Sydney, Sydney, Australia</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>I am Secretary of the Circumcision Academy of Australia, a government registered not-for-profit organization that I founded in 2010.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>7</day>
                <month>2</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Morris BJ</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport39413" related-article-type="peer-reviewed-article" xlink:href="10.12688/gatesopenres.15971.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>This study provides valuable data on costs of male circumcision of infants aged 0-60 days, and &gt; 14 years. Method used was a device, surgery, and device or surgery, for the respective age groups. The study found the respective costs were US$14.05,&#x00a0; $19.35, and $19.34 (surgery) and $20.5 (device).</p>
            <p> Comments</p>
            <p> Abstract Results, line 2: Change &#x201c;$14.05&#x201d; to &#x201c;US$14.05&#x201d;.</p>
            <p> line 3: Change &#x201c;USD $19.35&#x201d; to &#x201c;$19.35&#x201d;.</p>
            <p> Introduction, para 4, line 6: Change &#x201c;US $38.62- $44.24&#x201d; to &#x201c;US$38.62&#x2013;$44.24&#x201d;.</p>
            <p> line 8: Change &#x201c;US $35-$50&#x201d; to &#x201c;$35&#x2013;$50&#x201d;.</p>
            <p> Methods, para 1, line 14: Change &#x201c;follow- up&#x201d; to &#x201c;follow-up&#x201d;.</p>
            <p> Results, para 1, lines 15-16: If the device used was the Mogen clamp, then please state &#x201c;Mogen clamp device method&#x201d;. If not, then please state the types of devices used, especially as in para 2, lines 8 and 9 &#x201c;Devices&#x201d; (plural) are stated.</p>
            <p> para 2, line 5: Change &#x201c;USD $19.35&#x201d; to &#x201c;$19.35&#x201d;.</p>
            <p> para 3, line 10: Change &#x201c;year&#x201d; to &#x201c;years&#x201d; for &#x201c;10-14&#x201d; and &#x201c;over 14&#x201d;.</p>
            <p> para 5, line 9: Change &#x201c;$23.25 respectively and with&#x201d; to &#x201c;$23.25, respectively, and with&#x201d;</p>
            <p> para 6, line 7: Change &#x201c;14years&#x201d; to &#x201c;14 years&#x201d;.</p>
            <p> para 6, line 8: Change &#x201c;$24.4&#x201d; to &#x201c;$24.40&#x201d;.</p>
            <p> Discussion, para 2, line 13: Change &#x201c;as&#x201d; to &#x201c;was&#x201d;.</p>
            <p> para 3, lines 10-12: Change the style used for in-text citation of the references cited here from author-date to superscript numbers as used in the rest of the manuscript.</p>
            <p> para 4, line 4: Change &#x201c;high&#x201d; to &#x201c;higher&#x201d; and back this up with data on frequency of moderate and mild complications seen in each age group.</p>
            <p>Is the work clearly and accurately presented and does it cite the current literature?</p>
            <p>Yes</p>
            <p>If applicable, is the statistical analysis and its interpretation appropriate?</p>
            <p>Yes</p>
            <p>Are all the source data underlying the results available to ensure full reproducibility?</p>
            <p>Yes</p>
            <p>Is the study design appropriate and is the work technically sound?</p>
            <p>Yes</p>
            <p>Are the conclusions drawn adequately supported by the results?</p>
            <p>Yes</p>
            <p>Are sufficient details of methods and analysis provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Reviewer Expertise:</p>
            <p>Molecular genetics; male circumcision benefits and risks; epidemiology; public health; HIV and STIs. I was the first to develop and competitively patent the use of PCR for viral detection. My application of this technology to improve the accuracy of cervical screening for high-risk HPV resulted in the roll-out of this test. Since women whose male partners are circumcised have a lower risk of cervical cancer, I developed an interest in male circumcision, leading to 132 publications.</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.</p>
        </body>
    </sub-article>
</article>
