Study protocol on establishment of sentinel sites network for contraceptive and abortion trends, needs and utilization of services in Zika virus affected countries

Study protocol on establishment of sentinel sites network for contraceptive and abortion trends,... Background: ZIKV(Zika Virus) during pregnancy can result in many adverse events such as fetal deaths or newborns with congenital abnormalities including microcephaly and other neural irregularities. Due to these harmful outcomes of pregnancy associated with the Zika virus, we can expect to see a change in the type and scale of demand for family planning and safe abortion services in areas affected by the Zika virus. The monitoring and reporting capacities of the local health clinics in these areas could benefit from the introduction of infrastructural improvements necessary to establish a sentinel site network. Through these sites, the WHO will collect data on the situation from local health professionals to get real time information from the population group and act accordingly to mitigate the consequences of the Zika virus outbreak in a localized and culturally appropriate way. The objectives are to establish a sentinel sites surveillance network for reporting on uptake and utilization of contraception and safe abortion care services; to strengthen monitoring, and data quality assurance in the selected sentinel surveillance sites; and finally to assess the contraception and safe abortion care service utilization trends in the affected sites on a regular basis. Methods: The proposal includes a set of objectives and actions that enable the creation of a set of criteria for the selection of the sentinel sites, as well the implementation of monitoring and reporting systems that will be used in data collection. Discussion: The data collected will be used to better understand the changing demand for family planning and safe abortion needs. This will ultimately be used to inform local health workers and policy makers as to how best to track the continued Zika virus outbreak and mitigate the consequences. The learning from establishment of surveillance sentinel sites will help to strengthen health systems at regional and subregional levels that are more adaptable and capable of providing reproductive healthcare services and of responding to future emergencies. Keywords: Contraception demand, Sentinel Sites, Zika virus, Family planning, Safe abortion Plain english summary abortion availability. Because these services and products The Zika virus’ presence poses a significant threat to are not always readily available, more research is needed women of child-bearing age, and women who are or to identify coverage gaps and bolster infrastructure to may become pregnant in the foreseeable future. Some meet the growing and changing demand for these ser- Latin American health officials have recommended to vices. This will be done through the establishment of a postpone or avoid pregnancy and the WHO has stressed sentinel site network. This paper describes the function the continued importance of family planning and safe and historical significance of sentinel sites, and the justi- fication for the establishment of a network in Zika virus affected areas. The proposal includes the establishment * Correspondence: alimoa@who.int of strengthened monitoring and reporting systems, as well Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva 27 CH-1211, Switzerland © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Ali et al. Reproductive Health (2017) 14:19 Page 2 of 6 as emphasizing education of focal people in local health pregnant women about the potential consequences of clinics in the affected areas. Information will be collected Zika virus infection, or how to obtain an abortion, when via monthly reports, and shared in a dissemination report. such services is legal [10]. In other cases, pregnancies This study will inform policy makers for the purpose are unplanned or the result of sexual violence, as sex is of making long-term sustainable changes to strengthen not always a choice for women in these areas [11]. The the delivery of contraception and abortion services, in- advice to avoid pregnancy is controversial and difficult cluding treatment of complications and provision of post to follow, especially in contexts where abortion is largely abortion contraception care, sustainably and beyond the illegal and contraception is difficult to acquire. timeframe of this project. Due to the official recommendations and consequences Establishment of a sentinel site network in the selected regarding Zika virus and pregnancy, many women will Zika virus affected areas will work as a model and will likely want to postpose or avoid pregnancy in these areas, help to prepare the response and mitigate the negative leading to an increase in demand for contraception. impacts of the current Zika virus response and/or for Additionally, we can postulate that, without regular improved capacity of the health system to respond to access to contraception, women will increasingly seek community health care needs in sexual and reproductive abortion and post-abortion care. Indeed, the shift and health for future disease outbreaks. increase in demand is already happening- in November 2015, after PAHO (Pan American Health Organization) Background released a health advisory declaring the Zika virus a The presence of the Zika virus in the Americas is an on- health emergency in Latin America, a study showed going concern, and, as infection during pregnancy has that the demand and requests for abortions in Latin been linked to microcephaly, Guillain-Barré syndrome, American countries increased [12]. In the context of a and other developmental disorders in fetuses [1–3]. It crisis like the Zika virus outbreak, women will likely poses a threat to women of child-bearing age, and continue to seek out abortions and contraception women who are, or plan to become, pregnant. In February methods, but, without safe and legal access to meet of 2016, the WHO officially declared the Zika virus out- their demands, women will be driven to seek unsafe break to be a public health emergency [4] encouraging abortion and continue to have unplanned pregnancies. many countries in the affected areas to continue their preventative and protective actions for the populations Inequality of access to family planning in the context of at risk. humanitarian crises Prior to this, some Latin American health officials had The Ebola outbreak showed that many health systems already recommended a delay or postponing of pregnan- are vulnerable and can quickly break-down in the wake cies [5]; officials in some countries, like El Salvador and of a humanitarian crisis. Health centers in Liberia, Sierra Columbia, have urged avoiding pregnancy outright [6], Leone, and Guinea were overwhelmed by the Ebola out- while other countries had provided timelines regarding break, and, as the health system failed, many people pregnancy avoidance. In Brazil and Ecuador, women could not obtain the basic health care that they needed, have been recommended to indefinitely avoid pregnancy, and women in need of reproductive and obstetric care while other countries have recommended various time suffered [13]. As we saw with Ebola, health centers can limits; women were previously encouraged to postpose become overwhelmed and fail to meet the basic needs of for 6–8 months in Columbia, up to a year in Jamaica, its clients, and women in particular are disadvantaged, and until 2018 in El Salvador [7]. The WHO, while not especially in the context of sexual and reproductive recommending the avoidance of pregnancy in the context health. In order to avoid another health system break- of the Zika virus, recommended the provision of emer- down, countries in Zika virus affected areas should an- gency contraceptive services and counselling to all ticipate an increased demand for family planning and women that are at risk, as well as the continuation of contraception, and bolster their preparedness plans safe sex practices, access to family planning and access accordingly. to emergency contraception and counselling [8]. Additionally, inequality of access to health care plays a While these recommendations vary slightly, they are role in the Zika virus outbreak. Those that will be most similar in highlighting the necessity for the availability of likely negatively affected by the Zika virus are the poorer family planning products and contraceptive services to populations that are generally subject to health care avoid or delay pregnancies in the wake of a continued inequalities and poorer health. These at-risk populations outbreak. However, of the areas that are most affected tend to have a disproportionate lack of access to quality by the virus, few offer universal access to family plan- health care, and are at a greater risk of infection and ning services [9], and often have limited access to poor health due to poor sanitation, lack of clean water, contraception and insufficient information to currently and overcrowding. Additionally, public health programs Ali et al. Reproductive Health (2017) 14:19 Page 3 of 6 in these areas tend to be more readily available and ac- is the most common non-polio cause of AFP, and is also cessible to people of higher socioeconomic status before linked to some cases of Zika virus infection [19]. those of lower status, thus contributing to the cycle of This project intends to understand the changing needs poor health and inequality [14]. and demands for contraception and safe abortion, in- cluding treatment of post-abortion complications and Sentinel surveillance sites - experiences from the field provision of post abortion contraception in Zika virus A ‘Sentinel Site’ is a healthcare facility with a specified affected countries while also identifying weaknesses in geographical catchment area that is the focus of ‘place- the healthcare system and the capacities of healthcare based’ Sentinel Sites Evaluation activities. Sentinel surveil- workers to respond to the crisis under way. This project lance activities are often established to ensure high-quality will also include a training element to help health care data for a particular disease or intervention in limited re- workers develop better reporting and monitoring skills, source settings and the resulting analysis is used to inform as well as data-related skills to aid in the rapid collection programs and policies affecting a larger geographic area. and transmission of quality data to the Ministry of Many countries have developed surveillance activities Health in their area, creating a network of workers able for communicable diseases in order to monitor disease to properly collect and process data. Further to this aim, burden, detect outbreaks of epidemic-prone diseases WHO will provide a short orientation course on the and monitor progress towards national or international latest guidelines in contraception to the healthcare pro- control and eradication targets. Similar systems can be viders on the frontline to identify, prescribe and deliver used in situations where services may be overwhelmed by methods of choice through training in both research and demand. Whereas most passive surveillance systems re- service delivery. Finally, data derived from this project ceive data from as many health workers or health facilities will inform policy makers for the purpose of making as possible, a sentinel surveillance system deliberately in- long-term sustainable change to strengthen the delivery volves only a limited network of carefully selected report- of contraception and safe abortion services, including ing sites. The feasibility of sentinel surveillance has led treatment of complications from unsafe abortion and WHO to recommend that countries adopt the approach provision of post abortion contraception, sustainably for monitoring interventions and programs [15]. and beyond the timeframe of this project. Sentinel sites, and their consistent monitoring and reporting play an active role in the Polio Global Eradication Study aims and objectives Initiative as seen in their technical reports; these sites are The main aim of the project is to assess and strengthen encouraged to have proper information dissemination, ef- health care system response to changing needs and de- fective education of staff, contextually appropriate place- mands for contraception and safe abortion in emergency ment in a country, and adequate reporting techniques [16]. situations, specifically Zika-virus affected countries. Add- Sentinel sites, while associated closely with polio, have itionally, it will help to identify any weaknesses in the also been employed to combat other public health chal- healthcare system or the capacities of healthcare workers lenges. In Vietnam, during 1998–2003, sentinel sites to respond to the crisis underway. were established at 6 hospitals across 4 cities with the The objectives of this project are threefold. support of the WHO to track Rotavirus in young chil- The first objective is to identify and establish a sentinel dren; the sentinel sites proved to be a success in that, site surveillance network from pre-existing hospital sites with constant surveillance and dedicated supervision for reporting on uptake and utilization of contraception they were able to provide detailed and reliable data in a and safe abortion services in partnership with the minis- timely matter, all the while being cost effective [17]. try of health. The second objective is to strengthen Sentinel sites can also be used in a non-virus context, monitoring and reporting in health care for the selected and used instead to track emerging public health trends. sentinel surveillance sites, specifically for contraception For example, during 2008–2012 India had relative suc- and safe abortion services. The third objective is to de- cess in setting up and monitoring anti-malarial drug velop and strengthen the data-related activities in order resistance with a series of 25 sentinel sites. The sites to assess the contraception and abortion service trends were found to be an effective monitoring method to in the affected sites on regular basis. cover wide geographical areas, track trends, and com- municate effectively [18]. Methods/Design Recently, a report suggests that the use of already The sentinel sites will be established in ZIKV affected existing surveillance systems to track acute flaccid par- areas in collaboration with the Ministries of Health in alysis (AFP) is key to tracking potential Zika virus cases Brazil, Honduras and Panama. These areas will be iden- because of its relation to Guillain-Barre syndrome; tified in collaboration with local authorities and with the Guillain-Barre, while classified as a non-polio AFP case, cooperation of the state’s Ministry of Health. Ali et al. Reproductive Health (2017) 14:19 Page 4 of 6 The sentinel sites will be established following a three selected countries, as well as an implementation frame- stage process. The steps have been developed by the work and a set of key indicators on changing demand, WHO team in collaboration with partners from the capacity, needs, and trends in family planning and safe Ministry of Health, and are as follows: abortion. Key inputs will also include the development of monitoring and data collection tools. Step 1. Mapping of facilities in ZIKV-affected areas Key outputs will be largely based on the collection of All facilities in selected ZIKV-affected areas with the data on multiple factors, including the demand of potential to provide services in contraception and safe contraceptive and abortion services. The availability of abortion in selected countries i.e., Brazil, Honduras and the contraception available and the range of services will Panama will be identified and mapped in collaboration also be assessed, as well as the barriers to accessing with Ministry of Health. contraception and safe abortion services. Data will also Step 2. Assessment of health facilities be collected on the demographic and socioeconomic Following step 1, we will conduct a facility assessment in status of the clients/patients using the services. There ZIKV-affected areas on the provision of contraception will also be information collected regarding the devel- and safe abortion in the selected countries using opment of selection criteria and characteristics of senti- validated WHO tools. This activity will be reported in nel sites for contraceptive and abortion services, as well detail separately in a forthcoming article. as information on the personnel providing the services. Through the facility assessment, we will gather The collected data will help to identify the trends in information on the types of contraception and abortion contraception and abortion demands and clients’ use of services available in local health centers, and assess the services, and identify areas of weakness or strength in local health authorities’ readiness and qualifications in the existing health centers. addressing concerns and providing accurate information to clients/patients of all socioeconomic statuses. Quality assurance The facilities will be assessed using validated tools The principal investigator and project team will be developed by WHO. trained on the study purpose, design, quality assur- Step 3. Identification of sentinel surveillance sites ance, reporting mechanisms and data collection tools. The suitable sites, based on the result of above-mentioned Data collectors will also be trained to use the study assessment, will be identified in collaboration with MoH, questionnaire/tool for data collection from the facil- and be designated as sentinel sites. Infrastructure support ities and on entering the survey data in an online tool will be provided on the study tool, data collection and OpenClinica. Surveyors will be trained on data collec- data entry, monitoring, quality assurance and data tion, transmission, verification, storage and primary management. There will be comprehensive training analysis to assess errors. for focal persons on data collection and reporting All data will be entered into OpenClinica software systems at selected sentinel sites. tool by trained data operators. Measures will be taken to ensure the quality of collected data. All the forms Once established, the sentinel sites will monitor and will be checked on a daily basis for completeness, measure contraception and abortion service uptake and logical errors, and unclear or irrelevant responses. The trends in populations in the affected countries. The senti- principal investigator, co-investigator and project team nel sites will collect information on contraceptive method will make monitoring visits to ensure the quality of mix and provision, abortion, and the demographic and so- data and adherence to the study protocol. If needed, cioeconomic status of users. Information will also be col- refresher training will be arranged to enhance under- lected on method availability and staffing at the facilities standing of data collection tools. providing contraception and abortion services. The information from the sentinel sites will inform Scientific and ethical review improvements on the implementation of reproductive Scientific review and approval of the proposal has already health programs that include contraception and abor- been obtained from Research Projects Review Panel, the tion, identify how the programs could address barriers external review body of the Department of Reproductive to services, trends in demand of services and facilitate Health, and Research (WHO/RHR) including the effective implementation of programs at the local level UNDP/UNFPA/WHO/World Bank Special Programme to meet the needs of the target population. of Research, Development, and Research Training in Human Reproduction (HRP). Ethical approval for facility Deliverables assessment that will lead to identification of sentinel Key deliverables for the project will include a network of sites has also been approved by WHO Research Ethics sentinel surveillance sites in Zika virus affected areas in Review Committee. Ali et al. Reproductive Health (2017) 14:19 Page 5 of 6 Timeline of project lessons learned. This will be performed by the WHO We anticipate that the study will take 24 months. The regional offices and the Ministry of Health. initial stage included the development and finalization of Finally, in the second year, identification and imple- the concept note and the research proposal, technical and mentation of the sentinel sites will begin in Honduras ethics clearance as well as the initial identification of senti- and Panama, with a similar pattern of activities. nel sites. These activities will take place during Quarter I, in Brazil, with collaboration between WHO and the Discussion regional and county offices of the Ministry of Health. This paper describes the project proposal to create a The second phase of the project will occur in Quarter network of sentinel sites to aid in the capacity building II, and will consist of the development of the tools, data- of affected areas to meet family planning and safe abortion entry software, and the establishment of reporting proto- needs in the context of the Zika virus outbreak. Our ob- cols for the projects, including monitoring framework, jective is to firstly anticipate the potential shift and in- indicators, standard operating procedures and reporting crease in demand for family planning/contraception needs forms, data collection forms and reporting mechanisms. and safe abortion, and then to establish an integrated and The second component in Quarter II is the training of functional network of sentinel sites in the affected areas the sentinel site focal persons. This training will include for obtaining real time information from the field. data collection and recordkeeping, information reporting In long term, the data derived from this project will techniques (including timing and modality), and the provide evidence to strengthen contraception and safe establishment of the data quality control mechanism. abortion policies that will lead to sustainable change that While these activities are the main focus of this training will endure beyond the timeframe of this project. Estab- phase, there are secondary skills that will be strengthened lishment of a sentinel site network in the Zika virus through the training. These secondary skills include the affected areas will work as a model and will generate strengthening of contraceptive counselling using WHO substantial impact for the current Zika virus response guidelines, and service provision in LARC and emer- and/or for improved capacity of the health system to gency contraception. These activities will be performed respond to community health care needs in sexual and by WHO and the collaborating partners at the Minis- reproductive health for future disease outbreaks. tries of Health. Abbreviations Beginning in Quarter III, the focus of the project will LARC: Long-acting reversible contraception; SSE: Sentinel sites evaluation; shift to data collection and data entry, using the intro- TORs: Terms of reference; WHO: World Health Organization duced methods and guidelines. A major component of this phase will be the routine monthly clinic service record Funding The study is funded by Large Anonymous Donor under the Grant ID 5149 report, which will be eventually aggregated to quarterly for Women, Communities, and Health Systems in the Context of Zika. reporting data. This will be stated in the initial sites in The funding sources did not play a role in the study design, in the writing Brazil, and eventually be started in other locations. These of the report, or in the decision to submit the article for publication. activities will be carried out primarily by the sentinel site Availability of data and materials focal staff, with support from the WHO regional offices It is a study protocol so doesn’t have any specific data. and the respective ministries of health. After this shift to data collection in Quarter III, the Authors’ contributions project will move to a quarterly reporting phase which All authors contributed equally and have read and approved the final version. included validation of the quality of the data collected Competing interests and follow up procedures of the sentinel sites based on The authors declare that they have no competing interests. reported data. These activities will take place quarterly and include quarterly status reports, reporting telecon- Consent for publication All authors have agreed and have given consent for submission for publication. ferences, and feedback regarding implementation and any associated issues. These activities will be carried Ethics approval and consent to participate out by WHO, sentinel site focal persons, and the For facility assessment and focus group discussion ethical approval has been Ministry of Health. Additionally, there will be monthly obtained from WHO Research Ethics Review Committee under the project ID: A65912003747. analysis and report writing, and will include monthly reports on data collection, and quarterly report ana- Disclaimer lysis at the Ministry of Health. This report contains the collective views of an international group of experts, The dissemination process will occur at the end of the and does not necessarily represent the decisions or the stated policy of the World Health Organization. Quarter III and throughout Quarter IV. The aim of this dissemination is to assess the project on the ground, and Received: 13 December 2016 Accepted: 7 January 2017 adjust the reporting mechanism based on continuing Ali et al. Reproductive Health (2017) 14:19 Page 6 of 6 References 1. World Health Organization. Situation report: Zika virus, Microcephaly, Guillain-Barré syndrome. Geneva: World Health Organization; 2016. http://apps.who.int/iris/bitstream/10665/246155/1/zikasitrep30Jun16-eng. pdf?ua=1). Accessed 12 Jan 2017. 2. Costello A, Dua T, Duran P, Gülmezoglu M, Oladapo OT, Perea W, et al. Defining the syndrome associated with congenital Zika virus infection. Bull World Health Organ. 2016;94(6):406–A. 3. Brasil P, Pereira JP, Raja Gabaglia C, Damasceno L, Wakimoto M, Ribeiro Nogueira RM, et al. Zika Virus Infection in Pregnant Women in Rio de Janeiro. N Engl J Med. 2016;375:2321-34. doi:10.1056/NEJMoa1602412. 4. World Health Organization. WHO Director-General summarizes the outcome of the Emergency Committee regarding clusters of microcephaly and Guillain-Barré syndrome. Geneva: World Health Organization; 2016. http://www.who.int/mediacentre/news/statements/2016/emergency- committee-zika-microcephaly/en/. Accessed 12 Jan 2017. 5. British Broadcasting Corporation. Zika virus triggers pregnancy delay calls. 2016. http://www.bbc.com/news/world-latin-america-35388842. Accessed 12 Jan 2017. 6. McNeil D. Health Officials Split Over Advice to Delay Pregnancy. New York Times. 2016. https://www.nytimes.com/2016/04/15/health/zika-virus- pregnancy-delay-birth-defects-cdc.html. Accessed 12 Jan 2017. 7. McNeil D. Growing Support Among Experts for Zika Advice to Delay Pregnancy. New York Times. 2016. https://www.nytimes.com/2016/02/09/health/zika-virus- women-pregnancy.html?_r=0. Accessed 12 Jan 2017. 8. World Health Organization. Prevention of sexual transmission of Zika virus: Interim guidance update. Geneva: World Health Organization; 2016. http://apps.who.int/iris/bitstream/10665/204421/1/WHO_ZIKV_MOC_16. 1_eng.pdf?ua=1. Accessed 12 Jan 2017. 9. World Health Organization. One year into the Zika outbreak: how an obscure disease became a global health emergency. Geneva: World Health Organization; 2016. http://www.who.int/emergencies/zika-virus/ articles/one-year-outbreak/en/. Accessed 2 Sept 2016. 10. Roa M. Zika virus outbreak: reproductive health and rights in Latin America. Lancet. 2016;387(10021):843. 11. Editorial. The right(s) approach to Zika. Lancet Global Health. 2016;4(7):e427. DOI:http://dx.doi.org/10.1016/S2214-109X(16)30109-7. 12. Aiken AR, Scott JG, Gomperts R, Trussell J, Worrell M, Aiken CE. Requests for abortion in latin America related to concern about Zika Virus Exposure. N Engl J Med. 2016;375(4):396–8. 13. Menéndez C, Lucas A, Munguambe K, Langer A. Ebola crisis: the unequal impact on women and children’s health. Lancet Glob Health. 2015;3(3):e130. 14. Garcia-Subirats I, Vargas I, Mogollón-Pérez AS, De Paepe P, da Silva MR, Unger JP, et al. Inequities in access to health care in different health systems: a study in municipalities of central Colombia and north-eastern Brazil. Int J Equity Health. 2014;13:10. 15. World Health Organization. Global framework for immunization monitoring and surveillance. Geneva: World Health Organization; 2007. http://apps.who.int/iris/ bitstream/10665/69685/1/WHO_IVB_07.06_eng.pdf. Accessed 12 Jan 2017. 16. Polio Global Eradication Initiative. Technical sheets for polio eradication 2001. Geneva: Polio Global Eradication Initiative; 2001. http://polioeradication.org/. Accessed 12 Jan 2017. 17. Van Man N, Luan T, Trach DD, Thanh NT, Van Tu P, Long NT, et al. Epidemiological profile and burden of rotavirus diarrhea in Vietnam: 5 years of sentinel hospital surveillance, 1998–2003. J Infect Dis. 2005;192 Suppl 1:S127–32. 18. Mishra N, Singh JP, Srivastava B, Arora U, Shah NK, Ghosh SK, et al. Monitoring antimalarial drug resistance in India via sentinel sites: outcomes and risk factors for treatment failure, 2009–2010. Bull World Health Organ. 2012;90(12):895–904. 19. Kandel N, Lamichhane J, Tangermann RH, Rodier GRM. Detecting Guillain- Submit your next manuscript to BioMed Central Barré syndrome caused by Zika virus using systems developed for polio and we will help you at every step: surveillance. Bull World Health Org. 2016;94:705-8. doi:http://dx.doi.org/10. 2471/BLT.16.171504. • We accept pre-submission inquiries � Our selector tool helps you to find the most relevant journal � We provide round the clock customer support � Convenient online submission � Thorough peer review � Inclusion in PubMed and all major indexing services � Maximum visibility for your research Submit your manuscript at www.biomedcentral.com/submit http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reproductive Health Springer Journals

Study protocol on establishment of sentinel sites network for contraceptive and abortion trends, needs and utilization of services in Zika virus affected countries

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Medicine & Public Health; Reproductive Medicine; Public Health; Maternal and Child Health
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Abstract

Background: ZIKV(Zika Virus) during pregnancy can result in many adverse events such as fetal deaths or newborns with congenital abnormalities including microcephaly and other neural irregularities. Due to these harmful outcomes of pregnancy associated with the Zika virus, we can expect to see a change in the type and scale of demand for family planning and safe abortion services in areas affected by the Zika virus. The monitoring and reporting capacities of the local health clinics in these areas could benefit from the introduction of infrastructural improvements necessary to establish a sentinel site network. Through these sites, the WHO will collect data on the situation from local health professionals to get real time information from the population group and act accordingly to mitigate the consequences of the Zika virus outbreak in a localized and culturally appropriate way. The objectives are to establish a sentinel sites surveillance network for reporting on uptake and utilization of contraception and safe abortion care services; to strengthen monitoring, and data quality assurance in the selected sentinel surveillance sites; and finally to assess the contraception and safe abortion care service utilization trends in the affected sites on a regular basis. Methods: The proposal includes a set of objectives and actions that enable the creation of a set of criteria for the selection of the sentinel sites, as well the implementation of monitoring and reporting systems that will be used in data collection. Discussion: The data collected will be used to better understand the changing demand for family planning and safe abortion needs. This will ultimately be used to inform local health workers and policy makers as to how best to track the continued Zika virus outbreak and mitigate the consequences. The learning from establishment of surveillance sentinel sites will help to strengthen health systems at regional and subregional levels that are more adaptable and capable of providing reproductive healthcare services and of responding to future emergencies. Keywords: Contraception demand, Sentinel Sites, Zika virus, Family planning, Safe abortion Plain english summary abortion availability. Because these services and products The Zika virus’ presence poses a significant threat to are not always readily available, more research is needed women of child-bearing age, and women who are or to identify coverage gaps and bolster infrastructure to may become pregnant in the foreseeable future. Some meet the growing and changing demand for these ser- Latin American health officials have recommended to vices. This will be done through the establishment of a postpone or avoid pregnancy and the WHO has stressed sentinel site network. This paper describes the function the continued importance of family planning and safe and historical significance of sentinel sites, and the justi- fication for the establishment of a network in Zika virus affected areas. The proposal includes the establishment * Correspondence: alimoa@who.int of strengthened monitoring and reporting systems, as well Department of Reproductive Health and Research, World Health Organization, Avenue Appia 20, Geneva 27 CH-1211, Switzerland © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Ali et al. Reproductive Health (2017) 14:19 Page 2 of 6 as emphasizing education of focal people in local health pregnant women about the potential consequences of clinics in the affected areas. Information will be collected Zika virus infection, or how to obtain an abortion, when via monthly reports, and shared in a dissemination report. such services is legal [10]. In other cases, pregnancies This study will inform policy makers for the purpose are unplanned or the result of sexual violence, as sex is of making long-term sustainable changes to strengthen not always a choice for women in these areas [11]. The the delivery of contraception and abortion services, in- advice to avoid pregnancy is controversial and difficult cluding treatment of complications and provision of post to follow, especially in contexts where abortion is largely abortion contraception care, sustainably and beyond the illegal and contraception is difficult to acquire. timeframe of this project. Due to the official recommendations and consequences Establishment of a sentinel site network in the selected regarding Zika virus and pregnancy, many women will Zika virus affected areas will work as a model and will likely want to postpose or avoid pregnancy in these areas, help to prepare the response and mitigate the negative leading to an increase in demand for contraception. impacts of the current Zika virus response and/or for Additionally, we can postulate that, without regular improved capacity of the health system to respond to access to contraception, women will increasingly seek community health care needs in sexual and reproductive abortion and post-abortion care. Indeed, the shift and health for future disease outbreaks. increase in demand is already happening- in November 2015, after PAHO (Pan American Health Organization) Background released a health advisory declaring the Zika virus a The presence of the Zika virus in the Americas is an on- health emergency in Latin America, a study showed going concern, and, as infection during pregnancy has that the demand and requests for abortions in Latin been linked to microcephaly, Guillain-Barré syndrome, American countries increased [12]. In the context of a and other developmental disorders in fetuses [1–3]. It crisis like the Zika virus outbreak, women will likely poses a threat to women of child-bearing age, and continue to seek out abortions and contraception women who are, or plan to become, pregnant. In February methods, but, without safe and legal access to meet of 2016, the WHO officially declared the Zika virus out- their demands, women will be driven to seek unsafe break to be a public health emergency [4] encouraging abortion and continue to have unplanned pregnancies. many countries in the affected areas to continue their preventative and protective actions for the populations Inequality of access to family planning in the context of at risk. humanitarian crises Prior to this, some Latin American health officials had The Ebola outbreak showed that many health systems already recommended a delay or postponing of pregnan- are vulnerable and can quickly break-down in the wake cies [5]; officials in some countries, like El Salvador and of a humanitarian crisis. Health centers in Liberia, Sierra Columbia, have urged avoiding pregnancy outright [6], Leone, and Guinea were overwhelmed by the Ebola out- while other countries had provided timelines regarding break, and, as the health system failed, many people pregnancy avoidance. In Brazil and Ecuador, women could not obtain the basic health care that they needed, have been recommended to indefinitely avoid pregnancy, and women in need of reproductive and obstetric care while other countries have recommended various time suffered [13]. As we saw with Ebola, health centers can limits; women were previously encouraged to postpose become overwhelmed and fail to meet the basic needs of for 6–8 months in Columbia, up to a year in Jamaica, its clients, and women in particular are disadvantaged, and until 2018 in El Salvador [7]. The WHO, while not especially in the context of sexual and reproductive recommending the avoidance of pregnancy in the context health. In order to avoid another health system break- of the Zika virus, recommended the provision of emer- down, countries in Zika virus affected areas should an- gency contraceptive services and counselling to all ticipate an increased demand for family planning and women that are at risk, as well as the continuation of contraception, and bolster their preparedness plans safe sex practices, access to family planning and access accordingly. to emergency contraception and counselling [8]. Additionally, inequality of access to health care plays a While these recommendations vary slightly, they are role in the Zika virus outbreak. Those that will be most similar in highlighting the necessity for the availability of likely negatively affected by the Zika virus are the poorer family planning products and contraceptive services to populations that are generally subject to health care avoid or delay pregnancies in the wake of a continued inequalities and poorer health. These at-risk populations outbreak. However, of the areas that are most affected tend to have a disproportionate lack of access to quality by the virus, few offer universal access to family plan- health care, and are at a greater risk of infection and ning services [9], and often have limited access to poor health due to poor sanitation, lack of clean water, contraception and insufficient information to currently and overcrowding. Additionally, public health programs Ali et al. Reproductive Health (2017) 14:19 Page 3 of 6 in these areas tend to be more readily available and ac- is the most common non-polio cause of AFP, and is also cessible to people of higher socioeconomic status before linked to some cases of Zika virus infection [19]. those of lower status, thus contributing to the cycle of This project intends to understand the changing needs poor health and inequality [14]. and demands for contraception and safe abortion, in- cluding treatment of post-abortion complications and Sentinel surveillance sites - experiences from the field provision of post abortion contraception in Zika virus A ‘Sentinel Site’ is a healthcare facility with a specified affected countries while also identifying weaknesses in geographical catchment area that is the focus of ‘place- the healthcare system and the capacities of healthcare based’ Sentinel Sites Evaluation activities. Sentinel surveil- workers to respond to the crisis under way. This project lance activities are often established to ensure high-quality will also include a training element to help health care data for a particular disease or intervention in limited re- workers develop better reporting and monitoring skills, source settings and the resulting analysis is used to inform as well as data-related skills to aid in the rapid collection programs and policies affecting a larger geographic area. and transmission of quality data to the Ministry of Many countries have developed surveillance activities Health in their area, creating a network of workers able for communicable diseases in order to monitor disease to properly collect and process data. Further to this aim, burden, detect outbreaks of epidemic-prone diseases WHO will provide a short orientation course on the and monitor progress towards national or international latest guidelines in contraception to the healthcare pro- control and eradication targets. Similar systems can be viders on the frontline to identify, prescribe and deliver used in situations where services may be overwhelmed by methods of choice through training in both research and demand. Whereas most passive surveillance systems re- service delivery. Finally, data derived from this project ceive data from as many health workers or health facilities will inform policy makers for the purpose of making as possible, a sentinel surveillance system deliberately in- long-term sustainable change to strengthen the delivery volves only a limited network of carefully selected report- of contraception and safe abortion services, including ing sites. The feasibility of sentinel surveillance has led treatment of complications from unsafe abortion and WHO to recommend that countries adopt the approach provision of post abortion contraception, sustainably for monitoring interventions and programs [15]. and beyond the timeframe of this project. Sentinel sites, and their consistent monitoring and reporting play an active role in the Polio Global Eradication Study aims and objectives Initiative as seen in their technical reports; these sites are The main aim of the project is to assess and strengthen encouraged to have proper information dissemination, ef- health care system response to changing needs and de- fective education of staff, contextually appropriate place- mands for contraception and safe abortion in emergency ment in a country, and adequate reporting techniques [16]. situations, specifically Zika-virus affected countries. Add- Sentinel sites, while associated closely with polio, have itionally, it will help to identify any weaknesses in the also been employed to combat other public health chal- healthcare system or the capacities of healthcare workers lenges. In Vietnam, during 1998–2003, sentinel sites to respond to the crisis underway. were established at 6 hospitals across 4 cities with the The objectives of this project are threefold. support of the WHO to track Rotavirus in young chil- The first objective is to identify and establish a sentinel dren; the sentinel sites proved to be a success in that, site surveillance network from pre-existing hospital sites with constant surveillance and dedicated supervision for reporting on uptake and utilization of contraception they were able to provide detailed and reliable data in a and safe abortion services in partnership with the minis- timely matter, all the while being cost effective [17]. try of health. The second objective is to strengthen Sentinel sites can also be used in a non-virus context, monitoring and reporting in health care for the selected and used instead to track emerging public health trends. sentinel surveillance sites, specifically for contraception For example, during 2008–2012 India had relative suc- and safe abortion services. The third objective is to de- cess in setting up and monitoring anti-malarial drug velop and strengthen the data-related activities in order resistance with a series of 25 sentinel sites. The sites to assess the contraception and abortion service trends were found to be an effective monitoring method to in the affected sites on regular basis. cover wide geographical areas, track trends, and com- municate effectively [18]. Methods/Design Recently, a report suggests that the use of already The sentinel sites will be established in ZIKV affected existing surveillance systems to track acute flaccid par- areas in collaboration with the Ministries of Health in alysis (AFP) is key to tracking potential Zika virus cases Brazil, Honduras and Panama. These areas will be iden- because of its relation to Guillain-Barre syndrome; tified in collaboration with local authorities and with the Guillain-Barre, while classified as a non-polio AFP case, cooperation of the state’s Ministry of Health. Ali et al. Reproductive Health (2017) 14:19 Page 4 of 6 The sentinel sites will be established following a three selected countries, as well as an implementation frame- stage process. The steps have been developed by the work and a set of key indicators on changing demand, WHO team in collaboration with partners from the capacity, needs, and trends in family planning and safe Ministry of Health, and are as follows: abortion. Key inputs will also include the development of monitoring and data collection tools. Step 1. Mapping of facilities in ZIKV-affected areas Key outputs will be largely based on the collection of All facilities in selected ZIKV-affected areas with the data on multiple factors, including the demand of potential to provide services in contraception and safe contraceptive and abortion services. The availability of abortion in selected countries i.e., Brazil, Honduras and the contraception available and the range of services will Panama will be identified and mapped in collaboration also be assessed, as well as the barriers to accessing with Ministry of Health. contraception and safe abortion services. Data will also Step 2. Assessment of health facilities be collected on the demographic and socioeconomic Following step 1, we will conduct a facility assessment in status of the clients/patients using the services. There ZIKV-affected areas on the provision of contraception will also be information collected regarding the devel- and safe abortion in the selected countries using opment of selection criteria and characteristics of senti- validated WHO tools. This activity will be reported in nel sites for contraceptive and abortion services, as well detail separately in a forthcoming article. as information on the personnel providing the services. Through the facility assessment, we will gather The collected data will help to identify the trends in information on the types of contraception and abortion contraception and abortion demands and clients’ use of services available in local health centers, and assess the services, and identify areas of weakness or strength in local health authorities’ readiness and qualifications in the existing health centers. addressing concerns and providing accurate information to clients/patients of all socioeconomic statuses. Quality assurance The facilities will be assessed using validated tools The principal investigator and project team will be developed by WHO. trained on the study purpose, design, quality assur- Step 3. Identification of sentinel surveillance sites ance, reporting mechanisms and data collection tools. The suitable sites, based on the result of above-mentioned Data collectors will also be trained to use the study assessment, will be identified in collaboration with MoH, questionnaire/tool for data collection from the facil- and be designated as sentinel sites. Infrastructure support ities and on entering the survey data in an online tool will be provided on the study tool, data collection and OpenClinica. Surveyors will be trained on data collec- data entry, monitoring, quality assurance and data tion, transmission, verification, storage and primary management. There will be comprehensive training analysis to assess errors. for focal persons on data collection and reporting All data will be entered into OpenClinica software systems at selected sentinel sites. tool by trained data operators. Measures will be taken to ensure the quality of collected data. All the forms Once established, the sentinel sites will monitor and will be checked on a daily basis for completeness, measure contraception and abortion service uptake and logical errors, and unclear or irrelevant responses. The trends in populations in the affected countries. The senti- principal investigator, co-investigator and project team nel sites will collect information on contraceptive method will make monitoring visits to ensure the quality of mix and provision, abortion, and the demographic and so- data and adherence to the study protocol. If needed, cioeconomic status of users. Information will also be col- refresher training will be arranged to enhance under- lected on method availability and staffing at the facilities standing of data collection tools. providing contraception and abortion services. The information from the sentinel sites will inform Scientific and ethical review improvements on the implementation of reproductive Scientific review and approval of the proposal has already health programs that include contraception and abor- been obtained from Research Projects Review Panel, the tion, identify how the programs could address barriers external review body of the Department of Reproductive to services, trends in demand of services and facilitate Health, and Research (WHO/RHR) including the effective implementation of programs at the local level UNDP/UNFPA/WHO/World Bank Special Programme to meet the needs of the target population. of Research, Development, and Research Training in Human Reproduction (HRP). Ethical approval for facility Deliverables assessment that will lead to identification of sentinel Key deliverables for the project will include a network of sites has also been approved by WHO Research Ethics sentinel surveillance sites in Zika virus affected areas in Review Committee. Ali et al. Reproductive Health (2017) 14:19 Page 5 of 6 Timeline of project lessons learned. This will be performed by the WHO We anticipate that the study will take 24 months. The regional offices and the Ministry of Health. initial stage included the development and finalization of Finally, in the second year, identification and imple- the concept note and the research proposal, technical and mentation of the sentinel sites will begin in Honduras ethics clearance as well as the initial identification of senti- and Panama, with a similar pattern of activities. nel sites. These activities will take place during Quarter I, in Brazil, with collaboration between WHO and the Discussion regional and county offices of the Ministry of Health. This paper describes the project proposal to create a The second phase of the project will occur in Quarter network of sentinel sites to aid in the capacity building II, and will consist of the development of the tools, data- of affected areas to meet family planning and safe abortion entry software, and the establishment of reporting proto- needs in the context of the Zika virus outbreak. Our ob- cols for the projects, including monitoring framework, jective is to firstly anticipate the potential shift and in- indicators, standard operating procedures and reporting crease in demand for family planning/contraception needs forms, data collection forms and reporting mechanisms. and safe abortion, and then to establish an integrated and The second component in Quarter II is the training of functional network of sentinel sites in the affected areas the sentinel site focal persons. This training will include for obtaining real time information from the field. data collection and recordkeeping, information reporting In long term, the data derived from this project will techniques (including timing and modality), and the provide evidence to strengthen contraception and safe establishment of the data quality control mechanism. abortion policies that will lead to sustainable change that While these activities are the main focus of this training will endure beyond the timeframe of this project. Estab- phase, there are secondary skills that will be strengthened lishment of a sentinel site network in the Zika virus through the training. These secondary skills include the affected areas will work as a model and will generate strengthening of contraceptive counselling using WHO substantial impact for the current Zika virus response guidelines, and service provision in LARC and emer- and/or for improved capacity of the health system to gency contraception. These activities will be performed respond to community health care needs in sexual and by WHO and the collaborating partners at the Minis- reproductive health for future disease outbreaks. tries of Health. Abbreviations Beginning in Quarter III, the focus of the project will LARC: Long-acting reversible contraception; SSE: Sentinel sites evaluation; shift to data collection and data entry, using the intro- TORs: Terms of reference; WHO: World Health Organization duced methods and guidelines. A major component of this phase will be the routine monthly clinic service record Funding The study is funded by Large Anonymous Donor under the Grant ID 5149 report, which will be eventually aggregated to quarterly for Women, Communities, and Health Systems in the Context of Zika. reporting data. This will be stated in the initial sites in The funding sources did not play a role in the study design, in the writing Brazil, and eventually be started in other locations. These of the report, or in the decision to submit the article for publication. activities will be carried out primarily by the sentinel site Availability of data and materials focal staff, with support from the WHO regional offices It is a study protocol so doesn’t have any specific data. and the respective ministries of health. After this shift to data collection in Quarter III, the Authors’ contributions project will move to a quarterly reporting phase which All authors contributed equally and have read and approved the final version. included validation of the quality of the data collected Competing interests and follow up procedures of the sentinel sites based on The authors declare that they have no competing interests. reported data. These activities will take place quarterly and include quarterly status reports, reporting telecon- Consent for publication All authors have agreed and have given consent for submission for publication. ferences, and feedback regarding implementation and any associated issues. These activities will be carried Ethics approval and consent to participate out by WHO, sentinel site focal persons, and the For facility assessment and focus group discussion ethical approval has been Ministry of Health. Additionally, there will be monthly obtained from WHO Research Ethics Review Committee under the project ID: A65912003747. analysis and report writing, and will include monthly reports on data collection, and quarterly report ana- Disclaimer lysis at the Ministry of Health. This report contains the collective views of an international group of experts, The dissemination process will occur at the end of the and does not necessarily represent the decisions or the stated policy of the World Health Organization. Quarter III and throughout Quarter IV. The aim of this dissemination is to assess the project on the ground, and Received: 13 December 2016 Accepted: 7 January 2017 adjust the reporting mechanism based on continuing Ali et al. Reproductive Health (2017) 14:19 Page 6 of 6 References 1. World Health Organization. Situation report: Zika virus, Microcephaly, Guillain-Barré syndrome. Geneva: World Health Organization; 2016. http://apps.who.int/iris/bitstream/10665/246155/1/zikasitrep30Jun16-eng. pdf?ua=1). Accessed 12 Jan 2017. 2. Costello A, Dua T, Duran P, Gülmezoglu M, Oladapo OT, Perea W, et al. Defining the syndrome associated with congenital Zika virus infection. Bull World Health Organ. 2016;94(6):406–A. 3. Brasil P, Pereira JP, Raja Gabaglia C, Damasceno L, Wakimoto M, Ribeiro Nogueira RM, et al. Zika Virus Infection in Pregnant Women in Rio de Janeiro. N Engl J Med. 2016;375:2321-34. doi:10.1056/NEJMoa1602412. 4. World Health Organization. WHO Director-General summarizes the outcome of the Emergency Committee regarding clusters of microcephaly and Guillain-Barré syndrome. Geneva: World Health Organization; 2016. http://www.who.int/mediacentre/news/statements/2016/emergency- committee-zika-microcephaly/en/. Accessed 12 Jan 2017. 5. British Broadcasting Corporation. Zika virus triggers pregnancy delay calls. 2016. http://www.bbc.com/news/world-latin-america-35388842. Accessed 12 Jan 2017. 6. McNeil D. Health Officials Split Over Advice to Delay Pregnancy. New York Times. 2016. https://www.nytimes.com/2016/04/15/health/zika-virus- pregnancy-delay-birth-defects-cdc.html. Accessed 12 Jan 2017. 7. McNeil D. Growing Support Among Experts for Zika Advice to Delay Pregnancy. New York Times. 2016. https://www.nytimes.com/2016/02/09/health/zika-virus- women-pregnancy.html?_r=0. Accessed 12 Jan 2017. 8. World Health Organization. Prevention of sexual transmission of Zika virus: Interim guidance update. Geneva: World Health Organization; 2016. http://apps.who.int/iris/bitstream/10665/204421/1/WHO_ZIKV_MOC_16. 1_eng.pdf?ua=1. Accessed 12 Jan 2017. 9. World Health Organization. One year into the Zika outbreak: how an obscure disease became a global health emergency. Geneva: World Health Organization; 2016. http://www.who.int/emergencies/zika-virus/ articles/one-year-outbreak/en/. Accessed 2 Sept 2016. 10. Roa M. Zika virus outbreak: reproductive health and rights in Latin America. Lancet. 2016;387(10021):843. 11. Editorial. The right(s) approach to Zika. Lancet Global Health. 2016;4(7):e427. DOI:http://dx.doi.org/10.1016/S2214-109X(16)30109-7. 12. Aiken AR, Scott JG, Gomperts R, Trussell J, Worrell M, Aiken CE. Requests for abortion in latin America related to concern about Zika Virus Exposure. N Engl J Med. 2016;375(4):396–8. 13. Menéndez C, Lucas A, Munguambe K, Langer A. Ebola crisis: the unequal impact on women and children’s health. Lancet Glob Health. 2015;3(3):e130. 14. Garcia-Subirats I, Vargas I, Mogollón-Pérez AS, De Paepe P, da Silva MR, Unger JP, et al. Inequities in access to health care in different health systems: a study in municipalities of central Colombia and north-eastern Brazil. Int J Equity Health. 2014;13:10. 15. World Health Organization. Global framework for immunization monitoring and surveillance. Geneva: World Health Organization; 2007. http://apps.who.int/iris/ bitstream/10665/69685/1/WHO_IVB_07.06_eng.pdf. Accessed 12 Jan 2017. 16. Polio Global Eradication Initiative. Technical sheets for polio eradication 2001. Geneva: Polio Global Eradication Initiative; 2001. http://polioeradication.org/. Accessed 12 Jan 2017. 17. Van Man N, Luan T, Trach DD, Thanh NT, Van Tu P, Long NT, et al. Epidemiological profile and burden of rotavirus diarrhea in Vietnam: 5 years of sentinel hospital surveillance, 1998–2003. J Infect Dis. 2005;192 Suppl 1:S127–32. 18. Mishra N, Singh JP, Srivastava B, Arora U, Shah NK, Ghosh SK, et al. Monitoring antimalarial drug resistance in India via sentinel sites: outcomes and risk factors for treatment failure, 2009–2010. Bull World Health Organ. 2012;90(12):895–904. 19. Kandel N, Lamichhane J, Tangermann RH, Rodier GRM. Detecting Guillain- Submit your next manuscript to BioMed Central Barré syndrome caused by Zika virus using systems developed for polio and we will help you at every step: surveillance. Bull World Health Org. 2016;94:705-8. doi:http://dx.doi.org/10. 2471/BLT.16.171504. • We accept pre-submission inquiries � Our selector tool helps you to find the most relevant journal � We provide round the clock customer support � Convenient online submission � Thorough peer review � Inclusion in PubMed and all major indexing services � Maximum visibility for your research Submit your manuscript at www.biomedcentral.com/submit

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Reproductive HealthSpringer Journals

Published: Feb 2, 2017

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