Substance use disorders and perpetration of intimate partner violence (IPV) are interrelated, major public health problems.We surveyed directors of a sample of substance use disorder treatment programs  and batterer intervention programs  in California (70% response rate) to examine the extent to which SUDPs address IPV, and BIPs address substance abuse.Generally, SUDPs were not addressing co-occurring IPV perpetration in a formal and comprehensive way. Few had a policy requiring assessment of potential clients, or monitoring of admitted clients, for violence perpetration; almost one-quarter did not admit potential clients who had perpetrated IPV, and only 20% had a component or track to address violence. About one-third suspended or terminated clients engaging in violence. The most common barriers to SUDPs providing IPV services were that violence prevention was not part of the program’s mission, staff lacked training in violence, and the lack of reimbursement mechanisms for such services. In contrast, BIPs tended to address substance abuse in a more formal and comprehensive way; e.g., one-half had a policy requiring potential clients to be assessed, two-thirds required monitoring of substance abuse among admitted clients, and almost one-half had a component or track to address substance abuse. SUDPs had clients with fewer resources , and more severe problems . We found little evidence that services are centralized for individuals with both substance abuse and violence problems, even though most SUDP and BIP directors agreed that help for both problems should be obtained simultaneously in separate programs.SUDPs may have difficulty addressing violence because they have a clientele with relatively few resources and more complex psychological and medical needs. However, policy change can modify barriers to treatment integration and service linkage, such as reimbursement restrictions and lack of staff training. Substance use disorders and intimate partner violence (IPV) are interrelated, major public health problems. Of men entering substance use disorder treatment programs (SUDPs), approximately 60% have perpetrated IPV -4, and oThis study focused on a sample of programs in California to examine the extent to which SUDPs address IPV in their client population, and BIPs address SUDs among their clients. The study’s design was guided by a modified version of Moos’ 1997) conceptual framework  for info997 conceOrganizational factors that influence service linkages and outcomes include the program’s ownership, years of operation, size, staffing, annual budget, and revenue sources. Organizational factors are important to assess in part because they are associated with treatment services and client outcomes ,12. UnfoThe National Survey of Substance Abuse Treatment Services (N-SSATS), an annual survey of facilities providing substance abuse treatment, reported that most facilities are private, non-profit (58%), and that 60% receive government funding . PrivateA national survey of BIPs found that 43% were private-nonprofit, 48% were private-for-profit, and 9% were publicly owned . ProgramImportant client characteristics are indicative of personal needs and resources and include gender, race and ethnicity, socioeconomic status, court mandates to treatment, and types of substances used. Client characteristics are also likely to be associated with treatment services and outcomes. Again, however, there is a lack of data to directly compare client characteristics between SUDPs and BIPs.The N-SSATS found that most clients in facilities treating substance abuse were male 68%) and White (63%), with 21% Black and 14% Hispanic. In addition, 43% of clients had abused both alcohol and other drugs, 39% abused drugs only, and 18% abused alcohol only. Furthermore, 43% of clients had co-occurring mental health disorders . In the % and WhiGiven the high co-occurrence of SUDs and IPV perpetration, in-program practices of careful assessment, appropriate referral and intervention planning, and monitoring of at-risk clients are important for addressing both problems ,19-22. HAlthough there is relatively little definitive information, some evidence suggests that referrals to BIPs are infrequent (17%) even among SUDP clients with a pretreatment–year history of IPV perpetration, because providers inconsistently assessed IPV perpetration, or used assessment strategies that were not evidence-based . For exaStaff members in SUDPs often lack expertise in violence screening and treatment, and BIP staff members often do not have training in SUD assessment and treatment . In CollTreatments for both SUDs and IPV perpetration within the same program may be viewed as incompatible. SUDs are seen as the primary problem in SUDPs, and IPV perpetration is seen as primary in BIPs. SUDPs may view IPV perpetration as a problem not requiring intervention in its own right. In this view, the battering will stop if the substance use stops , or at lProgram completion rates are estimated at 42% in outpatient SUDPs nationally , and 50%Our aims were to study a sample of SUDPs and BIPs in California to be able to fully describe and directly compare programs. We examined programs’ organizational  and aggregate client characteristics . We also compared programs on policies about admitting clients with the cross problem, assessing and monitoring the cross problem, and referring treated clients who engage in the cross problem. For example, do SUDPs admit potential clients who have perpetrated IPV, and do BIPs admit potential clients who have misused alcohol and other drugs?We examined within-program treatment of the cross problem: what kinds of services, if any, do SUDPs offer for IPV perpetration, and do BIPs provide substance abuse services? Among programs that do not offer cross-problem services, what are the barriers to doing so? Do program directors believe that integrating substance abuse and violence treatment may give clients a higher likelihood of achieving positive outcomes? Improving our knowledge of how SUDPs and BIPs manage IPV perpetration and SUDs, respectively, will help policymakers gauge the extent to which inadequate service linkage is occurring and make recommendations accordingly. It will also help program managers and providers establish effective linkages and implement interventions better to reduce substance abuse and violence, thereby improving the quality of care in these settings.The sampling frame was all BIPs in the state, using a current listing by the California State Auditor. Specifically, the listing consisted of BIPs approved by criminal justice agencies  within each county jurisdiction. Although BIPs are not typically described as providing treatment for a diagnosed disorder, all would fall in the category of outpatient care. Within each of the state’s 58 counties, the same number of SUD outpatient treatment programs as BIPs was randomly selected, using SAMHSA’s Substance Abuse Treatment Facility Locator. Considering sampling with respect to county reduced the likelihood of extraneous factors  affecting results. We confirmed the accuracy of contact information and requested surveys from directors of 339 SUD treatment programs and 339 Batterer Intervention Programs. By using a sequence of follow-up procedures to target non-responders , we obtaWhere possible, survey items were drawn from previously used measures, i.e. the Residential Substance Abuse and Psychiatric Programs Inventory ,38; and The survey ascertained program organizational characteristics, aggregate client characteristics, within-program practices  and cross-program practices . It also assessed program-level outcomes among clients leaving the program in the past year: rates of program completion (“What percentage of the clients who left your program in the past 12 months completed the program [i.e. did not drop out or were terminated prematurely]?”), substance use abstinence , and IPV perpetration abstinence . Other specific items are described in the Results section.Evidence supports the validity of outcomes at the program (or client aggregate) level in that they are relatively stable  and have convergent and discriminate validity ,40. MoreWe compared SUDPs to BIPs mainly using t-tests for continuous variables, and chi-square tests for categorical variables.On average, the length of treatment obtained by SUDP clients was about six months . The majority (75% or more) of SUDPs offered the SUD-related services of individual counseling, group counseling, continuing care, or case management. Roughly one-third to one-half of programs offered marital or family counseling, mental health treatment, 12-step meetings on-site, job counseling, or help with housing. Fewer than one in four programs offered peer counseling, rides or subsidies for public transportation to and from the program, child care, smoking cessation, legal services, detoxification, or methadone and/or buprenorphine or other medications for SUDs. On a scale from 1=none, to 10=very strong, on average, programs were rated as placing more emphasis on abstinence from alcohol and drugs  than on harm reduction .Also on a scale of 1 (none) to 10 (very strong), on average, programs primarily emphasized a cognitive-behavioral , twelve-step , or motivational interviewing  treatment model. Less emphasized were Matrix, social, community reinforcement, psychodynamic, family, and dual diagnosis treatment models (means range from 5.8 to 6.8), and even lesser used were psychosocial rehabilitation, contingency management, and medical treatment models (means from 2.7 to 4.8).On average, the length of treatment obtained by BIP clients was one year . The majority of BIPs offered counseling for IPV perpetration in groups for men only (98.3%) and for women only (74.4%), but very few offered groups for men and women together (2.1%). The majority offered group or individual anger management counseling (60.7%), but fewer offered individual IPV perpetration counseling (39.7%). Parenting classes were offered by 40.3% of BIPs, but 12.0% or less offered marital or family counseling, peer counseling, legal services, child care, mutual-help groups for perpetrators on-site, or rides or subsidies for public transportation to and from the program. On the 1 (none) to 10 (very strong) scale, on average, programs primarily emphasized a cognitive-behavioral  or psychoeducational  treatment model, and put less emphasis on the Duluth, family systems, psychodynamic, or psychodrama model (means from 3.5 to 6.7).On average, compared to BIPs, SUDPs had been operating longer, served more clients, and had more paid staff, including those providing direct service to clients Table . SUDPs hBoth SUDPs and BIPs served a preponderance of men, but SUDPs had a lower proportion of men than BIPs did, as well as a lower proportion of Hispanic/Latino clients, and a higher proportion of White clients Table . On averSlightly over one-half of SUDP clients were mandated to treatment by the criminal justice system, but 91% of BIP clients were similarly mandated. SUDP clients were more likely to have been arrested for reasons related to substance abuse than were BIP clients, but even so, almost one-half of BIP clients had been arrested for substance abuse-related reasons. As expected, compared to BIPs, SUDPs had lower proportions of men and women who had been arrested for IPV perpetration.Less than one-quarter of SUDPs had a policy regarding the assessment of IPV perpetration among people seeking treatment, whereas over one-half of BIPs had a policy regarding assessment of substance abuse among potential clients Table . For botSUDPs were less likely than BIPs to require assessment of the cross problem, and to assess it at least sometimes among potential clients Table . Among pA total of 24.1% of SUDPs did not admit potential clients who had perpetrated IPV Table . The surAmong SUDPs that did not admit clients because of a known violence history, 78% provided the client with a referral; of these, referrals were most often to a BIP (78%) but may have been to the criminal justice system, such as a probation officer (29%), or to another SUDP (16%) (not tabled). Among SUDPs that did admit clients despite a known violence history, 93% made an additional requirement, recommendation, or referral; these clients were most often referred to the program’s own anger management component (50%), and less often to a BIP (42%), the program’s own batterer intervention component (21%), or the criminal justice system (9%).Among BIPs that did not admit clients because of a known alcohol abuse history, 92% provided the client with a referral. Of these programs, 70% sometimes referred the client to a SUDP, 41% to the criminal justice system, and 5% to another BIP. BIPs’ referral patterns of clients with drug abuse were quite similar to those for alcohol abuse.Among BIPs that admitted clients despite a known alcohol abuse history, 94% made an additional requirement, recommendation, or referral. Of these, 60% may refer the client to a SUDP to attend simultaneously, 24% may require or recommend participation in the same program’s substance abuse treatment component, 26% may mandate attendance at 12-step mutual-help groups, and 26% may refer the client to the criminal justice system. Again, results pertaining to drug abuse were quite similar to those for alcohol abuse.SUDPs and BIPs were comparable on the likelihood of offering at least one service targeting the cross problem; almost two-thirds of programs did so Table . SUDPs wSUDPs were less likely to have a component or track to address IPV perpetration than were BIPs to have a component or track to address substance abuse Table . Of SUDPOf BIPs with a component or track addressing substance abuse, 37% required the substance abuse component for all clients as a regular part of treatment, 19% required it only for clients with a history of substance abuse, 28% required it only for clients who have a history of substance abuse and were court-referred to treatment, and 16% made it optional for clients (not tabled). Also, of BIPs with a component or track addressing substance abuse, 85% provided substance abuse treatment in the same location where the BIP was located. As shown in Table Of programs that did not provide services for the cross problem, SUDPs were more likely than BIPs to state that cross services were not part of the program’s mission and that staff lack needed expertise Table . SUDPs wOnly 31% of SUDPs had a policy requiring the monitoring of IPV perpetration among clients, whereas 64% of BIPs had a policy requiring monitoring of substance abuse among clients Table . SUDPs aAmong SUDPs monitoring only selected clients for IPV perpetration during treatment , 42% monitored only clients with a violence history, and 58% had another practice or no program-wide practice (staff members made their own decisions) (not tabled). In most of these programs (60%), monitoring occurred with the frequency that staff members determined to be appropriate for each client.Among BIPs monitoring selected clients for substance abuse during treatment, 37% monitored only clients with a history of substance abuse, and 63% had another practice or no program-wide practice. In most of these programs (51%), staff members determined the frequency of monitoring clients.Just over one-third of SUDPs suspended or terminated clients who were known to perpetrate violence during treatment, and about the same proportion of BIPs suspended or terminated clients who were known to use substances during program participation Table . Among SAlmost all (97%) SUDPs that continued to treat clients despite a known violence event made an additional recommendation regarding violence-related interventions. Programs tended to recommend simultaneous attendance at a BIP (40%), an anger management program (38%), or a batterer intervention component in their program (15%). A total of 22% may refer the client to the criminal justice system, and 8% may give the client a warning or put the client on probation.Among BIPs that suspended or terminated clients because of known alcohol use, 94% provided the client with a referral. Of these, 77% referred the client to the criminal justice system ; programs sometimes referred the client to a SUDP (32%), and one program sometimes referred clients to another BIP. Results pertaining to program responses to drug use were quite similar to those for alcohol use.Among BIPs that continued to treat clients despite known alcohol use during treatment, virtually all (99%) made an additional recommendation regarding substance abuse interventions. Of these programs, 47% may refer the client to a SUDP to attend simultaneously, 38% may refer the client to the criminal justice system, 26% may require or recommend participation in the same program’s substance abuse treatment component, and 14% may give the client a warning or put the client on probation. These results pertaining to alcohol use closely resembled those for drug use.Less than one-half of SUDPs and BIPs followed up on referrals to determine if clients whose treatment was terminated due to the cross problem obtained help to which they were referred Table . Over onSUDPs were more likely than BIPs to have a single phone number for potential clients seeking help for both substance abuse and violence problems, but were less likely to have help available for both problems at a single location Table .Relatively few SUDPs and BIPs had an arrangement to refer clients to another program of the same type or of the cross type Table . Of progSUDPs were less likely than BIPs to require that all direct care staff be informed about assessing, treating, and monitoring the cross problem Table . They weEach program director was asked the extent to which the program integrates treatment of the cross problem into its core function . On average (not tabled), SUDPs were less integrated than were BIPs .When asked about the best way to serve clients with both problems, both SUDP and BIP directors most commonly answered that help for both problems should be obtained simultaneously, but in separate programs Table . SlightlRegarding clients seeking help for both substance abuse and violence perpetration, most SUDPs and BIPs permitted (did not prohibit) clients to obtain help for the cross problem while receiving services within the program Table . HoweverRegarding barriers to linkages between the SUDP and BIP communities, SUDP directors were more likely than BIP directors to endorse the barriers of lack of substance abuse training in BIPs, and lack of batterer intervention training in SUDPs, as well as the lack of a cross type of program in the same geographical area Table . SUDP diAmong clients leaving programs in the past year, SUDPs, in comparison to BIPs, had lower rates of program completion , but higher rates of clients who were abstinent from from perpetrating IPV .Generally, substance use disorder treatment programs were not addressing co-occurring violence in a formal and comprehensive way when we considered the in-program practices of client intake, treatment, and monitoring. Few SUDPs  had a policy requiring potential clients to be assessed for violence perpetration, although most (68%) assessed potential clients’ violence perpetration at least sometimes. Almost one-quarter of SUDPs did not admit potential clients who perpetrated IPV, and only about one-half followed up on referrals to determine that help was obtained. Anecdotal evidence suggested that non-admission of IPV perpetrators was due to staff perceptions that these clients needed mental health services beyond the scope of the SUDP. Only 20% of SUDPs had a specific component or track to address violence, and only about one-quarter offered individual or group counseling for IPV perpetration.The most common reasons SUDPs did not provide IPV services were that violence prevention was not part of the program’s mission, and staff members lacked training in violence prevention and management. Services outside SUDPs’ focus are often prohibited by reimbursement policies . That isIn SUDPs, monitoring violence among admitted clients appeared to be emphasized more than assessing violence among potential clients. Specifically, almost twice as many programs  had a policy requiring monitoring clients for violence. Still, only 48% of programs monitored violence at least sometimes. About one-third of SUDPs suspended or terminated clients known to engage in violence, and only 43% followed up on referrals to determine if terminated clients obtained help.In contrast, BIPs appeared to be addressing substance abuse in a relatively formal and comprehensive way. One-half (117 of 235 BIPs surveyed) had a policy requiring potential clients to be assessed for substance abuse, and 94% assessed potential clients’ substance abuse at least sometimes. Similar to SUDPs, one-quarter of BIPs did not admit potential clients with the cross problem, but a higher proportion (61%) followed up on referrals to determine if potential clients obtained help. In addition, 56% of BIPs offered group, and 29% offered individual, counseling related to substance abuse, and almost one-half of BIPs had a specific component or track to address substance abuse. SUD services were not provided in BIPs most often because they were not part of the program’s mission, and were not required for licensing, certification, or accreditation. Criteria for approving programs could be extended to include substance abuse assessment, treatment, and/or ongoing monitoring ,46.Supporting the idea that BIPs were more fully addressing substance abuse than SUDPs were addressing violence, we also found that 64% of BIPs (N=151) had a policy requiring monitoring of substance abuse among clients, and 83% monitored substance abuse at least sometimes. However, 40% suspended or terminated clients known to abuse substances, and similar to SUDPs, only 42% followed up on referrals to determine if terminated clients obtained help. BIPs may focus more on substance abuse because of widespread recognition by BIP directors that substance abuse among their clients is a predictor of program dropout ,48.It is possible that SUDPs placed less emphasis on addressing violence because their clients had fewer resources  and more severe and numerous problems needing attention . The difficulties of treating clients with multiple, complex problems may have competed with and dissuaded consideration of violence perpetration. Supplementary analyses (not yet presented) supported this hypothesis in that programs with higher proportions of clients who were unmarried, unemployed, and low-income, with both alcohol and drug use disorders, and both substance use and mental health disorders, were less likely to assess for and monitor the cross problem. On the other hand, SUDPs had a higher staff-patient ratio to address these challenges of the client population. Higher staff-patient ratios are indicative of higher quality care , but theReturning to the finding that SUDPs had clients with fewer resources and more severe problems, SUDPs may complete more frequent and thorough assessments of these problems than BIPs do, because SUDPs are administered by health agencies, and BIPs are administered within the criminal justice system. That is, SUDPs have the primary goal of service provision, whereas BIPs, as justice-related organizations, have the primary goal of public safety . Policy We found relatively little evidence that services are centralized for individuals with both substance abuse and violence-related problems. Roughly one-half of SUDPs and BIPs combined were able to help dual-problem clients via a call to only one phone number; SUDPs were more likely than BIPs to offer this aspect of centralization. However, about three-quarters of SUDPs and BIPs required clients with both problems to complete multiple sets of intake procedures. In addition, about three-quarters of SUDPs, and one-half of BIPs, did not provide help for both problems at a single location, despite findings that health care consumers prefer “one stop shopping” for co-occurring needs . FurtherAs reviewed by Bennett , in pracResearch also suggests that integrated substance abuse and family relationship treatment reduces both substance abuse and family violence for some couples. Our results show that a sizeable minority within both SUDPs and BIPs – about 30% -- endorse having help for both substance abuse and IPV perpetration integrated into one treatment program. In this regard, Behavioral Couples Therapy enhances both abstinence and relationship functioning to promote recovery and reduce violent behavior ,60. SimiIn keeping with having clients with fewer resources and more psychological and medical difficulties, SUDPs had higher attrition rates than BIPs did . AverageThis study had strengths and weaknesses. In terms of strengths, we achieved high response rates for this type of survey in samples of SUDPs and BIPs. We collected a substantial amount of useful information from both types of programs. Weaknesses are that we studied programs in only one state using a cross-sectional design with program-level outcomes, to the exclusion of client-level data. We did not independently audit each program; thus, the accuracy of data presented is based on reports by program directors, who may have slightly different responses in some cases than other staff members, such as clinicians . Even soWe found that SUDPs were addressing violence perpetration in a less formal and comprehensive way than BIPs were addressing substance abuse among their clients. More research is needed to determine whether a more comprehensive approach to addressing co-occurring substance abuse and violence contributes to better completion rates and client outcomes. To the extent that such associations exist, the information gathered in this study underscores that more could be achieved in terms of addressing cross problems and establishing linkages between these two types of programs.More could be done by programs in terms of assessing and referring clients who have the cross problem. At present, only 16% of SUDPs and 50% of BIPs require assessment of the other problem. Individuals who have experienced the cross problem are at risk of not being admitted to the program or for limited follow-up if they are given a referral. Alternative approaches to addressing dual substance abuse and violence problems that ensure clients’ access to services with more systematic follow-up have the potential to improve outcomes for these complex clients.We identified barriers to better linkages, such as lack of reimbursement and staff training for the cross problem, that are modifiable through changes in policy. In this regard, reimbursement policies could be altered to allow programs to bill for services related to addressing the cross problem, and certification policies could be changed to encourage staff training in the cross problem. To be feasible for implementation, staff policies may require only a subset of staff members, rather than all staff, to be trained in assessment, treatment, and referrals for the cross problem and their follow-through. Together, such policy changes could broaden the pool of staff trained in both types of problems, thus allowing for the enhancement and expansion of the program’s main mission or focus, and, in turn, the provision of appropriate services for clients with dual problems, such as in one integrated program or in separate but linked programs offering parallel services.Although we noted some important differences between clients in SUDPs and BIPs, there were also some broad similarities of clients in the two types of programs , suggesting that they may respond well to an integrated treatment approach. In this regard, the commonly used cognitive-behavioral model in both SUDPs and BIPs should ease efforts to integrate treatment. In addition, motivational interviewing, a treatment model emphasized heavily in SUDPs, is increasingly being applied in batterer programs , and so The consequences of failure to address co-occurring substance abuse and violence can be quite severe, including permanent injury or death to victims. Therefore, it behooves us to continue to effect policy change to facilitate treatment integration and service centralization to reduce substance abuse and perpetration of intimate partner violence.We, the authors, declare that we have no competing interests.CT conceived of and designed the study, oversaw data collection, set up, and analysis; and drafted and revised the manuscript. HV and PL made substantial contributions to the study design; collected, entered, set up, and analyzed the data; and helped to revise the manuscript. RM and GS made substantial contributions to the study design, data collection procedures, and interpretation of results, and helped to revise the manuscript. RC co-conceived, designed, and oversaw the study, and helped to revise the manuscript. All authors read and approved the final manuscript.


Male circumcision (MC) has been shown to reduce the risk of HIV acquisition among heterosexual men, with WHO recommending MC as an essential component of comprehensive HIV prevention programs in high prevalence settings since 2007. While Papua New Guinea (PNG) has a current prevalence of only 1%, the high rates of sexually transmissible diseases and the extensive, but unregulated, practice of penile cutting in PNG have led the National Department of Health (NDoH) to consider introducing a MC program. Given public interest in circumcision even without active promotion by the NDoH, examining the potential health systems implications for MC without raising unrealistic expectations presents a number of methodological issues. In this study we examined health systems lessons learned from a national no-scalpel vasectomy (NSV) program, and their implications for a future MC program in PNG.Fourteen in-depth interviews were conducted with frontline health workers and key government officials involved in NSV programs in PNG over a 3-week period in February and March 2011. Documentary, organizational and policy analysis of HIV and vasectomy services was conducted and triangulated with the interviews. All interviews were digitally recorded and later transcribed. Application of the WHO six building blocks of a health system was applied and further thematic analysis was conducted on the data with assistance from the analysis software MAXQDA.Obstacles in funding pathways, inconsistent support by government departments, difficulties with staff retention and erratic delivery of training programs have resulted in mixed success of the national NSV program.In an already vulnerable health system significant investment in training, resources and negotiation of clinical space will be required for an effective MC program. Focused leadership and open communication between provincial and national government, NGOs and community is necessary to assist in service sustainability. Ensuring clear policy and guidance across the entire sexual and reproductive health sector will provide opportunities to strengthen key areas of the health system. Large-scale clinical trials in Africa have shown that male circumcision (MC) has a protective efficacy of around 60% in preventing HIV acquisition in men -4. The cDespite the clarity of this recommendation, the complex social and cultural context of Papua New Guinea (PNG) and the distinctive features of the epidemic and local responses to it mean that the lessons of Africa cannot be directly transposed to PNG where adult medical male circumcision (MC) is currently being considered by the National Department of Health (NDoH) as part of a comprehensive HIV prevention strategy. PNG has among the highest HIV prevalences in the Asia-Pacific Region, estimated to be around 1.0% among adults aged 15 – 49 yrs -15. The Evidence from previous acceptability studies for MC in PNG suggests that various forms of penile foreskin cutting in communities exist but that these do not commonly involve circumferential cutting and the excision of the foreskin -22. EvenThe already established PNG no-scalpel vasectomy (NSV) program, which started in 1997, provides a suitable model for comparison . VasectoThe analysis of the NSV program offers a number of advantages within the complex health system of PNG:· It deals with an established program, rather than projections based on assumptions.· It allows for review of an existing program that addresses the relative technical difficulty of a surgical intervention compared to other prevention programs.· It provides an analysis removed from direct discussions about MC and other HIV/AIDS initiatives in PNG which avoids raising expectations among health workers and communities that a MC program is about to be rolled out.· It presents evidence for a retrospective analysis of issues around training, resource availability, financing, health workforce, and service delivery, in an analogous context.By drawing attention to the broad range of influences on the health system demonstrated through the analysis of the NSV program, this study assists in providing a proxy framework on how a future MC program could exist within an already vulnerable health system.In this paper we present the findings of a qualitative study conducted to explore lessons from the development and implementation of the NSV program in PNG to understand health system readiness for a potential MC program if it is deemed appropriate. This study is part of a multi-disciplinary, community-based research program to investigate the acceptability, epidemiological impact, cost-effectiveness and options for program implementation of MC for HIV prevention in PNG: the Male Circumcision Acceptability and Impact Study (MCAIS) which is being conducted by the PNG Institute of Medical Research in collaboration with the University of Queensland and the University of New South Wales in Australia.Using a mixed method qualitative approach, data was collected over a 3 week period in February and March 2011 and combined a triangulation of qualitative methods including key informant interviews (KII); documentary and policy analysis; and structured and unstructured observations of identified NSV services. An iterative, purposive sampling technique was used to identify potential participants for the KII with upper level health system officials involved in the coordination of the national NSV program. Four NSV services were chosen as case studies based on reports of active service from the upper health system officials and included 1 non-government organization (NGO), 1 hospital clinic and 2 government outpatient clinics located in four provinces of PNG including, East Sepik Province: ESP, Eastern Highlands Province: EHP, Madang Province: MDGP and National Capital District: NCD  in PNG and the Human Research Ethics Committees of the University of New South Wales and the University of Queensland. Written informed consent was sought from all individuals participating in interviews. Confidentiality was maintained in the data transcription process, which used pseudonyms to identify respondents. Consideration was given by all researchers to the customs, practices and legal systems in PNG, potential for language barriers and the provision of a clear understanding of research objectives to all participants involved in this study.With the support of United Nations Population Fund (UNFPA), NSV has been operational in PNG since 1997 following the training of 25 PNG health care professionals in Indonesia to obtain an international certificate of NSV from the Association for Voluntary Surgical Contraception International (AVSC). The NSV program has been integrated within public health services and non-government organizations (NGOs), similar services that may be called upon to incorporate a MC program. However, the momentum to sustain a NSV program has been very difficult in PNG according to the results of 14 KIIs  representing four NSV services in PNG  provides an important component of the NDoH family planning program for safe motherhood, as well as a strategy to address population growth in PNG (an identified concern since independence in 1975). The NSV program is overseen by the NDoH with the decentralized health system resulting in provincial governments being responsible for administrating and prioritizing the service at a local level. NSV has been highlighted within numerous PNG policy documents including the National Health Plan (2011–2020); Reproductive Health Policy (2009); National Family Planning Policy (2007); and National Population Policy (2000–2010); to assist in reducing the burden of maternal mortality and morbidity in PNG, as part of the Millennium Development Goal to improve maternal health. However despite this support, the NSV program competes with a number of other priorities within provincial and national health departments. As a result, control of the program as a nationwide effort is often underpinned by provincial and district level priorities resulting in mixed results throughout the country. Table National level officials acknowledged that there were historical difficulties for effective governance and leadership of the NSV program for various reasons. In particular, leadership on strengthening the health system in general was seen as a much needed priority for the success of any program."Getting the health systems right in the first place is a priority. Because at the moment our health systems are in tatters, they have collapse, anything outside a couple of successful provincial hospitals. And nothing else much works.""KII upper health system"Other key issues highlighted by upper lever health system officials include the effectiveness and efficiency of the government to organise an effective program, including promotion and implementation Table "Family planning has been identified as an important issue. So in terms of priorities it is in the policy document. Now it is the question of translating it into actual operations and this does rely on the capacity of the facilities. However, you also have got national provincial and district government. So we can come up with a policy or a statement saying that the priority is this, but when it goes to actual service delivery it depends if it is a priority at the other levels. There may be other challenges that they may face.""KII Upper Health System Official"Sustainability of services was often described to be heavily reliant on key drivers within provincial government and frontline health services as well as ongoing financial commitment from both provincial and national governments. As one provincial health official who worked within a province with a successful NSV program explained:"At the provincial level, we have a budget for family health services because one of our priorities is family health services including safe motherhood. Vasectomy falls within this. Because now we can see that our population is increasing at a very alarming rate. And compared with economic development, the population is just growing miles. We understand this, so in this province one of our priorities is the family planning program.""KII Provincial Health Official"The impact of poor leadership was evident with many of the frontline health workforce. According to frontline HWs interviewed, feelings of poor support from government including difficulties accessing funds and resources was often a problem. As a result, many had difficulties with maintaining momentum for the service."…I could have done better but I got stranded, logistically, the transport and all this. And the thing is the province they didn’t give me enough support. And also in my district, even though they knew NSV was very important, they couldn’t fund it. They couldn’t support me.""KII frontline HW"Funding for the NSV service has been historically sourced from a variety of government and multinational organizations, in particular the UNFPA and Health Sector Improvement Program (HSIP). With funding coordination at national government level, provincial governments are responsible for obtaining money and allocating it to the service accordingly. Participants reported ongoing difficulties with accessing funds to support NSV activities including supervision of newly trained health workers, providing outreach services and obtaining equipment Table "So we have no funding for the training and we are still waiting, I don’t know where the funding will come from. The funding will come, but from which source I don’t know. I am still waiting. I will just wait.""KII frontline HW"In two of the provinces reviewed, NGOs have been able to bridge the gap by providing financial or technical support to the training program or outreach services. Maries Stopes and Pathfinder International are the only two NGOs currently operating in PNG that have become involved with the NSV program. Pathfinder International provides financial support for training and allowances for outreach services in Madang Province. Marie Stopes operates at urban clinics and provides peri-urban outreach services in Port Morseby, NCD, as well as supporting NSV programs in more remote areas of Central Province. Small user fees were required by one NGO to access the service. NGO support is not available in all provinces but some provinces, such as EHP, have successfully implemented NSV programs without direct local-NGO support.Systemic issues such as funding, and provincial and national government support resulted in uneven service deliver across provinces and over time Figure . Other kHigh demand and increasing waiting lists for the NSV service were commonly experienced in rural areas. However, waiting lists also existed in urban settings due to irregular financial support of designated staff, as well as inflexible times at which the service could be offered:"Last year, we had two clients that were booked for vasectomies, but the doctor who was going to do the vasectomies wanted to do it on a Saturday, and these two guys, they go to church on Saturdays, so they couldn’t come. And they are still on the waiting list.""KII frontline HW"Raising expectations within communities for services through promotional activities resulted in a construction of obligation between worker and potential client. With increasing awareness and demand, but no service to support this, creation of dissatisfaction within the community became evident. For example, one respondent described an incident where he was confronted by a man who was particularly frustrated with waiting for the service."One client arrived here with a very bad temper. And he says “I am waiting and waiting and I have already four children.” He wanted to try and sue me for not arranging to go to him [in his village] because while he was waiting he had two sets of twins. And that made him really angry. So he came and said “your program is not a good program.” So he was not just talking about the procedure itself but the waiting that existed for us to go out and do the procedure. That was one of my struggles that I had.""KII frontline HW"According to frontline HWs an increasing demand for NSV services had been observed and was believed to stem from increasing economic pressures and demand for land experienced in communities as people continued to have large families. One HW also reported that after providing NSV services within a small community, he discovered that some men appeared to have been motivated by a desire to have more sexual partners without the fear of having more children.A challenge with developing efficient and effective health information systems in PNG was a concern for all upper health system officials."Our population is so scattered and so remote, we try to build up our surveillance as much as possible. And because of the remoteness of our communities it is a great challenge to us. And try to build up a system that will enable us to get information quickly, to respond to it quickly. But you know it has been a great challenge to us.""Upper Health System Official"This was evident in the review of the NSV program with details of national statistics for NSV services difficult to obtain prior to 2002. Estimates derived by triangulating data from several sources, suggest that the data recorded in Figure "…the national picture for me at the moment is, well I know that the demand is there for vasectomy services and that there are limited service providers. That is the general picture, the general statement I can make. But in reality in terms of hard data, I cannot prove that.""KII upper level health official"Numbers on waiting lists were also often difficult to ascertain. No data on adverse events, including infection rates or failure rates, appeared to be systematically collected by any of the NSV services reviewed. Post-operative monitoring was also rarely completed due to the difficulties of access, population mobility and limited ability to contact people in PNG e.g. lack of mobile phone ownership or access in rural areas. These difficulties were noted to be a significant problem by all upper level health officials.All frontline HWs reported that access to essential medicines and equipment for the NSV service was not a real problem despite upper level health officials suggesting that access difficulties were a common problem in PNG and likely had a significant impact on NSV service provision. However frontline HWs did report significant difficulties in accessing drugs for other components of the family planning service."I order the drugs through the local guys, but they told me that the won’t be ordering drugs for family planning commodities. Now family planning drugs are coming from Moresby. Like the vaccines. So I ordered them in November and I still haven’t got the supplies here [4 months later]. And ah we called this morning and they said the person who is in charge for doing the order for the, the family planning orders, he has been sacked or something. So now we are running out of things and have to send people elsewhere.""KII Nurse"Lack of transport for the NSV program, particularly for outreach visits, was considered more of an important obstacle by all frontline HWs. To deliver outreach programs, the HWs reported needing to rely on vehicles from other programs to assist."Equipment and drugs for the NSV I would not say is really bad, I think there is enough. But the biggest problem is that we do not have transport. At one stage, I thought that I was going to get a vehicle so I started planning my program to go from district to district there, and not be restrictive to the district here.However, it was given to someone else.""KII CHW"Expanding human resources has been a key objective of government policy since the initiation of the NSV program in 1997. HWs at different levels have been trained including doctors, health extension officers (HEOs), nursing officers (NOs) and community health workers (CHWs). Difficulties with attrition of trainees and in implementing the NSV accreditation program continue to be reported by both frontline HWs and upper health system officials."I have trained health workers but we don’t know how they progress. I have no idea where they are now, or whether they are performing the procedures or not. So it is a sad story to me… It’s a waste of funds and all that, just training them and leaving them like that.""KII frontline HW"Training and support supervision are provided by a small number of clinicians in PNG and even fewer clinicians are currently able to certify HWs as vasectomists. A certified vasectomist would be expected to have demonstrated competent skills by completing 50 supervised vasectomies  as well as proficient theoretical knowledge to implement the procedure. However, with limited supervisors available, many HWs who have received training have subsequently been left unsupervised and uncertified. Little information was available about what happens to those who are trained but unable to complete the supervision and certification program. This was a concern of both upper level health officials and frontline HWs."The training part is easy, we can do that. The difficult bit is the follow up. Follow up supervision. That has been really poor. Even from the beginning. I was in Madang, we trained 50 or 53 health workers. And so far we have only certified two of them.""KII Upper level health official"These difficulties with implementing the training and supervision program were reported as due to a lack of staff to deliver the program, but also to difficulties with accessing funds and general travel to areas in PNG. Frontline HWs who have been certified all describe long periods of waiting to be officially certified and recognized as a vasectomist."I am a CHW. I did my training on vasectomy as hands on training. And they certified me with a certificate from UNFPA; they gave me a certificate last year, early last year. But I went previously for more than 10 years, on vasectomies before that.""KII frontline HW"There were also reports from respondents admitting to performing unsupervised NSV, despite not being officially certified.Upper level health officials acknowledged the importance of frontline HW’s initiative and dedication to their post-training program. The onus on frontline HW to promote services within the community and to maintain strong communication with trainers and upper level health officials, was considered an important factor in staff retention difficulties and an inability of the service to prevent staff migration to other programs.It was unanimous among all upper level health officials and those involved in training that among all HWs, CHWs were the most likely to remain dedicated to providing and sustaining NSV services. This was considered a result of their work being conducted directly within communities."CHWs are interested, because they are right at the post where the population is. So it really acts like something that is very important to them, that is why they have been so successful.""KII frontline HW"Community engagement was identified as an integral part of a successful NSV program due to CHWs ability to promote the service.This analysis of four active NSV services currently operating in PNG provided an opportunity to consider the health systems implications of a national MC program without raising expectations that such a program was about to be introduced. The results suggests caution in implementing a future MC program, given obstacles in funding pathways, inconsistent support by government departments, difficulties with staff retention and erratic delivery of training programs With no current national MC program in PNG, and previous research indicating penile cutting as part of the cultural landscape, the underlying complexities in health service delivery in PNG uncovered in the analysis of the NSV suggests that focusing on strengthening the health system was of paramount importance before attempting to initiate and roll-out any new prevention technologies.According to mathematical modelling research, it is predicted that male circumcision will have a moderate impact on the PNG HIV epidemic overall with benefits reduced or eliminated by changes in sexual behavior . TherefoEffectively mobilising human resources has been a widely discussed topic in the implantation of a MC program in African countries -32. ThisOf particular concern for a future MC program, poor monitoring and recording of men who have undergone NSV, as well as identification and follow up of trained HWs, were recognised as problems in the current NSV program. Unevenness of NSV service provision appeared to exist across provinces and over time, however, a clear picture of the national program was difficult to obtain due to gaps in recorded statistics. The need for systematic monitoring and evaluation of MC services across government and NGO sectors is important, to observe gaps in workforce and other resources; to determine if priority targets are being met; and to identify changing demands or other issues within the program .The challenges of implementing national MC programs in Africa have also centred around the ability to access sustained domestic and international funding with leadership and visible champions at all levels to mobilise essential for maximum effect ,32,40. GThe role of NGOs in the roll out of MC programs in Africa has not been fully explored; however the potential benefit of an integrated approach needs further consideration. The success of NGO efforts in technical and financial support to strengthen service delivery in key provinces in PNG for NSV may be applied to a national MC program. For example, dilemmas were reported around access to appropriate transport particularly for rural outreach visits and concerns were raised around access to enough medicines and essential equipment. Partly out-sourcing a future MC program to the NGO sector in PNG could provide an opportunity for technical and financial assistance in managing key issues identified in the NSV study.In Kenya, consistent political support and ongoing community consultation have allowed implementation challenges for MC to be addressed as they arise . The neeEvidence of formal incentives for clients and HWs were observed and contributed to the promotion of the NSV service. However, difficulties with understanding motivations in clients were also reported by frontline HWs. As health workers were the only ones interviewed in this paper, minimal conclusive insight could be provided towards the community perceptions of NSV and the reasons for accessing the service. The impact of socio-cultural factors such as religion, traditional and contemporary understandings of family planning and the prevention of disease requires further exploration. The motivations for men accessing a MC program will need to be carefully monitored due to the potential for the program to result in reductions in condom usage, although such risk compensation has not been observed in other settings -45.A dedicated men’s health service or clinic appeared to have the most success in promotion, access and uptake of NSV. With the minimum package for MC services as defined by WHO including voluntary counselling and testing (VCT); treatment and exclusion of STIs; and safe sex counselling , a number of other opportunities arise for managing men’s sexual health in PNG . PromotiThe research project involved qualitative research methods. However, as with the nature of qualitative research, data results are limited in their ability to be generalized to the wider population. The case study analysis of the NSV program in PNG utilised by the researchers has advantages, but also some limitations. Studying a case poses challenges since it involves more variables than data points. The case study approach was also constrained by factors impacting case selection including a limited number of known NSV services identified by the NDoH; available time; and access to the services. However, the case summaries presented provide a general picture of the situation at a particular point in time and an opportunity to better understand casual factors that enable or hinder similar health programs.Analysis of the NSV program in PNG reveals a history of complexities around funding, resourcing, service delivery, management and sustainability of the national program. Lessons from this experience show that a number of health system priorities need to be addressed before a national MC program can be considered. Understanding how to effectively utilise and support staff in a sustainable way is integral to the success of the program. Decisions about service delivery models should acknowledge not only the cultural sensitivities of the communities but also the likely impact on health resources that a MC program would have on this already vulnerable health system. Defining responsibilities for sustainable funding, program leadership and the role of non-government and development partners will be essential. Ensuring clear policy and guidance across the entire sexual and reproductive health sector will provide opportunities to strengthen key areas of the health system.The authors declare that they have no competing interests.PH, AT & AV participated in the conception of study design. Technical assistance was obtained from GL, AK and JM. Fieldwork was conducted by AT. Data analysis was carried out by AT with assistance from PH & AV. The manuscript was drafted and revised with support and contributions from PH, AV, AK, GL, JM, PS, & JK. All authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/12/299/prepub


Corynebacterium pseudotuberculosis (Cp), is associated with direct economic losses and presents significant zoonotic potential. Despite the importance of the disease, a satisfactory vaccine model has not been developed. Thus, this study aimed to investigate the association between haptoglobin (Hp) and IgM levels and the clinical progression of CLA in primarily infected sheep and in sheep immunized with Cp- secreted antigens adjuvanted with Quillaja saponaria saponins. These animals were kept with CLA-positive sheep to simulate natural exposure that occurs in field conditions. During the experiment, the Hp and IgM levels were monitored for 21 days, and the development of internal CLA lesions was investigated through necropsies on day182 post-immunization.Sheep caseous lymphadenitis (CLA), caused by 5 Cp virulent strain) had higher Hp values between the first and ninth days post inoculation (PI) than sheep in Group 1 . Immunized animals in Group 3 had significantly higher Hp values between the third and seventh days PI, compared with the control group (P < 0.01). Binary logistic regression (BLR) analysis of primarily infected sheep indicated an association between Hp concentration and CLA clinical progression: animals with high Hp values had 99.9% less risk of having CLA abscesses than animals with low Hp levels . Both experimental groups had significantly higher IgM titers than the control group around the ninth and eleventh days PI (P < 0.05). The BLR analysis for immunized sheep indicated an association between IgM levels and clinical progression: sheep with high IgM titers had 100.0% less risk of having CLA abscesses than animals with low IgM levels .Primarily infected sheep in Group 2 (inoculated with 2x10C. pseudotuberculosis infection is supported by the early acute phase response, in which up-regulation of Hp and IgM were predictive of a lower risk of CLA lesion development. Because the immunogen used in this study induced a high production of both Hp and IgM, Q. saponaria saponin should be considered a promising candidate in vaccine formulations against sheep CLA.Resistance to  Corynebacterium pseudotuberculosis (Cp). In addition to the direct economic losses that may occur due to leather depreciation and weight gain delay [Caseous lymphadenitis (CLA) is a chronic infectious disease of sheep and goats caused by the gram-positive bacteria in delay ,2, CLA pin delay .Despite the importance of the disease, a satisfactory vaccine model for sheep and goats has not been developed. Current knowledge of the immunity induced by Cp indicates that resistance to infection involves both nonspecific and specific host responses. Antibodies help protect against infection ,5, but fQuillaja saponaria-derived saponins can be considered as potential candidates in vaccine formulations [Considering the hypothesis that full protection against Cp would be achieved by Th1 T cell activation, ulations . These sulations . The aimWe used two Cp strains in this study. The T1 strain was used to produce secreted antigens in a previously optimized chemically defined medium (CDM) . This anFifteen one-year-old Santa Inês ewes were used in the experiment. Santa Inês is a naturalized breed from northeastern Brazil and the experimental animals all came from the same flock. Animal selection was based on several criteria, including body condition, helminth-free state as defined by fecal egg count, normochromic mucosa at visual inspection, normal rectal temperature and absence of abscesses or enlarged lymph nodes on palpation. No sheep had clinical signs of CLA and all were seronegative on an indirect ELISA at the beginning of the study.5 CFU of the Cp virulent strain VD57 on day zero. Group 3 (n = 6) was immunized with 1 ml of a solution containing 250 μg of CDM-secreted antigens adjuvanted with 1.5 mg of Quillaja saponaria saponin (Sigma-Aldrich) on day zero, and received an immunization booster on day 56. The adjuvant was prepared by dissolving the saponin at a concentration of 150 mg/ml in sterile 0.9% saline solution as a stock solution and filtering through a 0.22 μm membrane. On the immunization days, the saponin stock solution was added to the secreted antigen to a final concentration of 1.5 mg/ml [We determined our sample size based on the experimental design described previously to investigate the acute phase protein response in an experimental model of ovine caseous lymphadenitis . Factors.5 mg/ml , and theThis experiment was conducted under the authority of Brazilian Law nº11.794, 8 October 2008 , after approval by the Secretariat of Animal Health of the Ministry of Agriculture, Livestock and Food Supply. Slaughter was conducted at a slaughterhouse supervised by the National Meat Inspection Service of the same Ministry.Blood samples were collected before inoculation/immunization (day zero) and on days 1, 3, 5, 7, 9, 11, 14 and 21 post-inoculation (PI). On each occasion, one blood aliquot was collected using vacuum tubes without anticoagulant and allowed to clot at room temperature, for serum collection. These samples were tested to determine Hp and IgM levels.2O2 solution (0.02 mol/L) were added. After 5 minutes, absorbance at 490 nm was measured using a microplate reader .Serum Hp concentration was estimated based on hemoglobin-binding capacity in microtitration plates, as previously described . A stand-specific IgM antibodies was performed as previously described [2O2 and tetramethylbenzidine  for 15 minutes, and stopped with 4 N H2SO4. Results were read in an ELISA plate reader (Bio-Rad) at 450 nm.The indirect ELISA for detection of Cpescribed . ELISA mst day), clinical assessment continued for six months, with all animals clinically examined twice per month through the inspection of superficial lymph nodes and routine blood sampling. External abscesses found during the experiment period were sampled through an incision with sterile surgical equipment, followed by drainage of purulent material into sterile flasks for bacteriological assays. After the 182-day observation period, animals were necropsied at the Baby Bode slaughterhouse , which has an official meat inspection system and performs postmortem pathology inspections. All external and internal lymph nodes, and tissue samples with lesions suspected to be caused by Cp, were collected and microbiologically assayed according to previously described protocols [Although blood sampling focused on the acute phase period  were determined using the nonparametric Mann–Whitney test. Based on the summary of records of external abscesses and post-mortem examination Table , a seconThe results of CLA lesion detection are presented in Table The distribution of Hp values for each group during the acute phase is shown in Figure Hp values clustered according to the presence or absence of CLA lesions are presented in Figure 5 CFU of Cp virulent strain VD57 induced higher IgM responses in Group 2 than immunization did in Group 3, but these differences were not significant. Both experimental groups had significantly higher IgM values on days 9 and 11 PI compared with the control group (P < 0.05). These results suggest that the adaptive immune response can first be measured on day 9 PI.The distribution of IgM values for each group is presented in Figure 5 CFU Cp virulent strain had elevated IgM levels during the acute phase period. However, in Group 3, only those animals that did not develop CLA abscesses had high IgM titers between days 9 and 21 PI. Binary logistic regression analysis indicated a significant association between high IgM values and the absence of CLA lesions .IgM data clustered according to the presence or absence of CLA lesions are presented in Figure CLA is an important disease that affects sheep and goats, with no satisfactory commercially available vaccine. In developing a reliable immunogen it is important to consider the acute immune response, and IgM and Hp are among the most important parameters during this phase of the disease. Our aim in this study was to observe the kinetics of these two acute phase markers in the progression of CLA lesion development.Three sheep in Group 3  developed CLA abscesses, probably as a result of natural exposure to sheep with clinical CLA and draining lesions. The observed tropism for the lungs was previously described in a study evaluating lesions in mice inoculated with four equine Cp strains, which demonstrated distinct tropism for the liver, spleen, lungs or mesenteric lymph nodes . In thisThe saponin-adjuvanted CDM-secreted antigen induced a strong acute phase response between days 1 and 7 after immunogen inoculation. Haptoglobin is one of the most sensitive acute phase markers of inflammatory and infectious conditions in ruminants. This protein can be used to assess the innate immune response to vaccination in sheep . The exiMycobacterium tuberculosis infection [The OR obtained for Group 2 shows that the animal with high Hp values during the acute phase response had 99.9% less risk of developing CLA abscesses than animals with low Hp levels. Although Group 3 had the highest Hp levels, no association between Hp levels and CLA lesion development could be detected. We were unable to detect an association because inoculation with the saponin-adjuvanted immunogen induced a strong Hp reaction in all sheep. It has been suggested that a high Hp level during the acute phase of Cp infection represents a good prognosis for the clinical progression of CLA in sheep . One posnfection .Nocardia brasiliensis[Mycobacterium tuberculosis[The OR calculated for Group 3 indicated that sheep with high IgM titers during the acute phase period had 100.0% less risk of developing CLA abscesses than animals with low IgM levels. Few studies regarding IgM antibody levels during Cp infection have been published to date, but our results agree with studies demonstrating the protective effect of the humoral antigen-specific IgM response against siliensis,24 and Merculosis.Based on the Hp and IgM results of Group 3, it is possible to infer that the saponin-adjuvanted CDM-secreted antigen induced early defense mechanisms during the acute phase period. However, it is not plausible to consider Hp and IgM as uniquely responsible for protection against CLA. Although few vaccine models using saponins as adjuvant have been tested in veterinary medicine, prior studies have shown promising results in protecting against murine visceral leishmaniasis , bovine Quillaja saponaria saponin should be considered as a promising candidate in CLA vaccine formulations. Understanding the pathways initially activated by Cp antigens is crucial to construct an effective vaccine model. We highly recommend further studies on the modulation of immunity by adjuvants during the acute phase of CLA using a wider variety of immunological markers.Establishing the kinetics of Hp and IgM production during the acute phase of infection in our two models enabled us to characterize the association of these variables with the clinical progression of CLA in sheep. The results indirectly demonstrate that resistance to Cp infection is supported by the early acute phase response, with up-regulation of Hp and IgM predicting a lower risk of developing CLA lesions. Because the immunogen used in this study induced high production of both Hp and IgM, Corynebacterium pseudotuberculosis; CLA: Caseous lymphadenitis; PI: Post-inoculation; Hp: Haptoglobin; IgM: Immunoglobulin M; BHI: Brain heart infusion; PBS-T: Phosphate-buffered saline with 0.05% Tween 20; BLR: Binary logistic regression; OR: Odds ratio.Cp: All authors have no competing interests.BLB undertook sample collection and laboratory experiments, analyzed the results and drafted the manuscript. DL, JTR and MTG were responsible for laboratory experiments. JEG and VA contributed to the design of field data collection. VLCV, LFMC, RWP and RM contributed to the design, writing of the manuscript and coordination of the study. All authors have read and approved the manuscript.Complementary table presenting the single haptoglobin value (g/l) for each sheep during the acute phase period.Click here for fileComplementary table presenting the single IgM value  for each sheep during the acute phase period.Click here for file


In 2007, the World Health Organization endorsed male circumcision as an effective HIV prevention strategy. In 2008, the Government of Kenya (GoK) launched the national voluntary medical male circumcision (VMMC) program in Nyanza Province, the geographic home to the Luo, the largest non-circumcising ethnic group in Kenya. Currently, several other African countries are in the early stages of implementing this intervention.This paper uses data from a health facility needs assessment (n = 81 facilities) and a study to evaluate the implementation of VMMC services in 16 GoK facilities  to describe Kenya's experience in implementing the national program. The needs assessment revealed that no health facility was prepared to offer the minimum package of services as outlined by the national guidelines, and partner organizations were called upon to fill this gap. The findings concerning human resource shortages facilitated the GoK's decision to endorse trained nurses to provide VMMCs, enabling more facilities to offer the service. Findings from the evaluation study resulted in replacing voluntary counseling and testing (VCT) with provider-initiated testing and counseling (PITC) and subsequently doubling the proportion of VMMC clients tested for HIV.This paper outlines how certain challenges, like human resource shortages and low HIV test rates, were addressed through national policy changes, while other challenges, like large fluctuations in demand, were addressed locally. Currently, the program requires significant support from partner organizations, but a strategic plan is under development to continue to build capacity in GoK staff and facilities. Coordination between all parties was essential and was facilitated through the formation of national, provincial, and district VMMC task forces. The lessons learned from Kenya's VMMC implementation experience are likely generalizable to other African countries. Male circumcision (MC) is the surgical removal of the penis foreskin and is practiced around the world for medical, religious, and cultural purposes. The 2007 Kenya AIDS Indicator Survey reported that 85% of Kenyan men were circumcised and 7.4% of the population was HIV positive To date, over 40 observational studies, and three randomized controlled trials (RCTs), have established that MC reduces the risk of HIV acquisition in heterosexual men by approximately 60%.In response to consistent research findings and the WHO/UNAIDS policy statement, the Government of Kenya (GoK) launched a national Voluntary Medical Male Circumcision (VMMC) program in November, 2008. The GoK plans to circumcise 860,000 men during the next five years, and partner organizations were invited to support the GoK by implementing program activities and building capacity during the initial phase.This paper uses data from a facility needs assessment and a study evaluating the roll-out of the VMMC program to elucidate challenges, responses, and lessons learned during the first year of implementing the national VMMC program in Nyanza Province, Kenya. While this is not intended to be a full report, it is the first evaluation, including recommendations and possible solutions, to be published. Our experience is likely to be useful to several African countries, with health delivery systems similar to Kenya, which are in the early stages of implementing comparable programs.The health facility needs assessment was conducted through the National AIDS and STI Control Programme to support the Kenya Ministry of Health and to inform policy and resource allocation at the launch of the VMMC program. Since the facility assessment was conducted for administrative purposes, and not research, no approval was sought from ethical review committees in- or out-side of Kenya. All evaluation study research staff completed the online Collaborative Institutional Training Initiative training course on human subject protection. Written consent (adults) or assent and parental permission (minors) was obtained from all study participants. The evaluation study was approved by the University of Illinois at Chicago Institutional Review Board in Chicago, USA (protocol: 2007-0913), and the Kenyatta National Hospital Ethics and Research Committee, Nairobi, Kenya (protocol: P338/11/2007).The data presented in this paper come from two sources: 1) a health facility needs assessment and 2) a study evaluating VMMC implementation in GoK health facilities. All data were collected in Kisumu and Nyando districts in Nyanza Province, Kenya.The health facility needs assessment was conducted February-October, 2008, prior to the launch of the national VMMC program. All health facilities in the two districts were surveyed (n = 81) using a 3-page questionnaire. The in-charge clinician, or designee, was interviewed and the resources available for VMMC were visually observed by the assessment team. The assessment focused on the seven minimum criteria for MC service provision as outlined in the Kenya national clinical manual including:Room available for surgery Room available for recoveryTrained and available staffSterilization and infection control complianceHIV voluntary counseling and testing (VCT) and risk-reduction counselingSTI syndromic diagnosis and treatmentProvision and promotion of male and female condomsThe evaluation study was conducted in 16 GoK health facilities to assess the implementation of the program through monitoring VMMC clients from pre-procedure through 40-days post-MC. VMMC clients, aged ≥12 years, who voluntarily elected to be circumcised and gave their written informed consent/assent to participate in the study, were eligible to enroll in the study . Data were analyzed using SAS version 9.1; descriptive results are presented here.Eighty-one health facilities were assessed, and no facility possessed all seven VMMC criteria necessary to provide safe services .Most facilities had inadequate infrastructure. Few (14.8%) had an existing minor theater; 64.2% had space for a minor theater to be renovated; and 21% had no space for a minor theater. Similarly, 35% of facilities had no space available for a recovery room even if renovations were provided.Renovations were provided to six GoK facilities by partner organizations. These facilities were chosen after conducting a spatial analysis considering proximity to major roads, availability of staff to provide MC services, and size of population in catchment area; a well-accessed facility, with adequate client flow was also considered. Renovations included partitioning, painting, minor repairs, installing doors and windows, plumbing, and electrical work. The cost of renovations varied by the amount of work that needed to be done at each facility .Most facilities were not prepared to provide VMMC services without the provision of equipment and supplies from partner organizations. For example, nearly all facilities reported providing syndromic STI management (96.3%), but based on visual observation, only 9.9% had an adequate STI drug supply. Additionally, while GoK facilities committed to providing HIV test kits for the VMMC program, “stock outs” occurred frequently which negatively impacted HIV testing uptake.Necessary equipment and supplies were provided to GoK facilities including: autoclaves, surgical couches, lamps, trays, trolleys, linens, privacy curtains, reusable surgical packs, and consumables. The cost of consumables per procedure was $14.67. Since the GoK committed to providing HIV test kits, partner organizations sought authorization to request kits directly from the national supplier in order to closely monitor and manage the stock in the field. The national medical supply agency plays an integral role in the implementation of a surgical HIV prevention intervention, and should be engaged early in the scale-up process, even if consumables are being supplied in the short-term, since it can take considerable time to coordinate the distribution of supplies and to add VMMC supplies to the Essential Drugs and Supplies List.At the time of the assessment, only medical officers and clinical officers were authorized to provide VMMC services in Kenya. There were few medical officers in the study districts (n = 8), and 12.4% of facilities had an adequate numbers of clinical officers to offer VMMC services . The assessment revealed that 85.2% of facilities had an adequate number of nurses to provide VMMC services, but at the time of the assessment, nurses were not legally approved to provide VMMC services.Conducting an assessment informed our understanding of the health staffing shortage, which plagues many African countries, and supported the efforts of the national MC task force to lobby for trained nurses to be authorized to perform VMMC procedures. The GoK announced this authorization on June 17, 2009. Despite the resulting increase in the VMMC workforce, GoK staff continue to struggle to incorporate VMMC into their routine duties mostly because staff report that they are too busy to devote time to providing a non-emergency procedure. Although partner organizations have trained over 1,000 GoK staff (including nurses), few are able to provide VMMC services routinely. Among VMMC clients in the evaluation study, 12% were circumcised by GoK staff. There are several possible explanations for this level of MC service provision among GoK staff including: MC is not a GoK performance indicator and is not included on the routine health monitoring form, and this can result in a lack of motivation to provide MC services; partner organizations provided MC services for almost one year before the GoK officially launched the VMMC program resulting in the perception that program was partner-initiated and partner-led; and health facilities have an inadequate number of staff to provide routinely what is perceived as a non-emergency, preventive service. In accordance with the national strategic plan, the GoK continues to request that partner organizations provide services during this initial phase while increasing their efforts to build the capacity of GoK staff to sustain the national program.At the time of the assessment, approximately 1/3 of facilities offered voluntary counseling and testing (VCT) services. When considering VCT and provider initiated testing and counseling (PITC) together, 70.4% of facilities were prepared to offer HIV counseling and testing along with VMMC services. During the first months of providing VMMC services, VCT was implemented, and acceptance was <25%. Finally, HIV testing and counseling, along with MC counseling, proved to be a time-consuming process, often lasting over one hour per client.Partner organizations worked with the GoK to provide the necessary training to replace VCT with a PITC approach, and testing rates have increased to over 60%. Additionally, an “HIV testing target” of 80% has been set for each VMMC-dedicated team, and performance evaluations include an assessment of this target. In order to improve counseling efficiency, without sacrificing quality, “group education” sessions were implemented to explain the risks and benefits of MC to clients of the same age group at one time. Group counseling is followed by individual counseling during which clients, in a private setting, can ask questions they have, be tested for HIV, and receive personalized risk reduction counseling. This adaptation to the counseling protocol has reduced the total counseling time per client by approximately 50%. While we considered offering HIV testing and counseling to only sexually active clients, the national PITC guidelines state that all clients receiving care at a health facility should be screened for HIV. Currently, there are no national guidelines for the provision of MC services to HIV-positive men. In order to avoid unnecessary stigma, males deemed clinically fit to undergo surgery, who do not show signs of the Acquired Immunodeficiency Syndrome (AIDS), are eligible to receive MC services.Kenya adapted WHO's “Manual for Male Circumcision Under Local Anesthesia” to fit the Kenya context, and VMMC service providers were trained using this manual.Since partner organizations provided the majority of services during the first year, a variety of service provision strategies, including fixed site and mobile service provision, were implemented and evaluated. Over 50% of services were provided by mobile partner teams working in small, low-resourced health facilities that lacked resources to provide services on their own. Mobile services were also provided in high-demand settings . In these settings, one service provision team, consisting of one clinical officer, nurse, counselor, and hygiene officer, working on two surgical couches simultaneously, task-sharing , and task-shifting , with optimal client flow, can perform up to 20 procedures per day. In order to increase efficiency for mobile teams, drivers were trained to assist with cleaning and preparing surgical packs. While mobile services can have additional costs due to the transport required and the carriage of additional items such as tents, tables and chairs, they can be very effective in high demand settings when multiple teams can work together using high efficiency models.The VMMC program was launched in November, 2008, but national reporting tools were not launched until January, 2010. While members of the national and provincial MC task forces collaborated to develop the forms, this was a time-consuming process, and in the interim, partner organizations created their own, non-standardized forms, leading to difficulties in data aggregation.We recommend that providers agree on core indicators and data collection tools before launching the program (WHO and PEPFAR MC indicators provide a good starting place), to ensure the collection of comparable data on indicators of interest.Matching client demand with service provision has been difficult. For example, while the GoK strategy targets males aged ≥15 years of age, 29% of clients are younger than 15 years. The traditional age for MC in neighboring communities ranges from 8–15 years, so parents and adolescents of this age discuss MC and are habituated to circumcision at these ages. Additionally, some VMMC implementing partners are organizations targeting primarily youth, so mobilizing youth was a natural result of their other program activities. Also, demand varies with school holidays, fishing seasons, and planting or harvest seasons.The large turn-out of adolescents resulted in revising our training and techniques for counseling adolescents about sex and reproductive health as well as standardizing the process for providing preventive medical services to a minor which now requires written parental permission and minor client assent. While minors continue to seek and receive MC services, because circumcising young boys delays the impact of this intervention, and most new HIV infections occur in adult men, we are developing new strategies to increase the number of males aged ≥18 years seeking VMMC services, like partnering with large employers in the region, using a voucher system, and offering incentives to mobilizers who recruit men aged over 18 years.Service provision plans must be highly flexible to respond to changes in demand. Several strategies have been implemented to respond to fluctuations in demand including: 1) the creation of a master list of trained staff who can be hired on a temporary basis during high-demand periods; 2) the formation of mobile, rapid response service teams that are not assigned to a site, but move freely to sites with high demand; and 3) the implementation of client prioritization schemes serving males aged ≥18 years first, followed by males aged 15–17 years, and then younger minors. Additionally, MC-dedicated staff are encouraged to take leave during periods of low-demand.While there are efforts underway to improve the efficiency of the MC procedure itself, we have learned that efficiency depends more on optimal client flow and efficient counseling and screening than on the time required for the procedure itself. Ultimately, if the surgery is efficient, but insufficient clients are present the impact of the program is compromised. Similarly, if there are ample clients present, but the pre-surgical processes are inefficient and time-consuming, the program is compromised. To this end, efforts to increase efficiency should be aimed at increasing demand and improving counseling efficiency rather than focusing exclusively on improving the efficiency of the surgical component of the MC process.This evaluation has summarized the challenges, responses, and lessons learned during the implementation of an effective VMMC program in Kenya which has circumcised over 230,000 males in less than two years.Recommendations from the national VMMC program in Kenya that may benefit other African countries implementing comparable programs include the following:Renovations to facilities may be necessary to scale-up program activities, and these improvements can be expensive, so it is important to develop a system to identify and prioritize high-volume, high-impact facilities.Health facility needs assessments are recommended to inform data-based decision-making about necessary programmatic and policy changes .As a surgical intervention, VMMC programs require well-coordinated partnerships between multiple government agencies  and partner organizations. In Kenya, this was facilitated by the formation of dynamic national, provincial, and district MC task forces that met monthly and were well-attended by GoK representatives and all partner organizations.VMMC programs must be responsive to the variation in demand. Strategies like creating a pool of trained staff that can be temporarily hired, dedicating mobile teams to move around to facilities with high demand, implementing client priority schemes, and encouraging MC-dedicated staff to take leave during low-demand periods have been effective in responding to fluctuations in demand.While the national VMMC program was well-supported by committed governmental and non-governmental entities at all levels, for the program to be sustainable, GoK staff working at health facilities must also be committed to the program and empowered to provide the service. To this end, additional GoK staff need to be trained, the provision of VMMC services needs to be added to their job descriptions, and barriers to service provision need to be explored.In order to evaluate the implementation of a national VMMC program, a data monitoring system should be implemented before services are provided.Despite our findings and recommendations, gaps still remain in our understanding of how to move the program forward. To guide us, we are currently assessing the barriers that trained GoK providers experience in providing services. We are evaluating techniques to strengthen the referral system between VMMC service sites and all HIV testing sites, and we are exploring new strategies to ensure consistent client flow.