International Sexual Health And REproductive (I-SHARE .

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International Sexual Health And REproductive (I-SHARE) Health Survey duringCOVID-19: study protocol for online national surveys and global comparative analysesKristien Michielsen,1,2 Elin C. Larsson,3,4 Anna Kågesten,5 Jennifer T. Erausquin, 6 SallyGriffin,7 Sarah Van de Velde,8 Joseph D. Tucker,9,10,11 for the I-SHARE Team*1International Centre for Reproductive Health, Department of Public Health and Primary Care,Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium2Academic Network for Sexual and Reproductive Health and Rights Policy (ANSER), Ghent,Belgium3Department of Womens and Childrens Health, Karolinska Institutet, Stockholm, Sweden4Department of Womens and Childrens Health, Uppsala University, Stockholm, Sweden5Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden6Department of Public Health Education, University of North Carolina Greensboro,Greensboro, USA7Centro Internacional para Saúde Reprodutiva, Maputo, Mozambique8Department of Sociology, University of Antwerp, Antwerp, Belgium9Institute of Global Health and Infectious Diseases, University of North Carolina at ChapelHill, Chapel Hill, USA10Faculty of Infectious and Tropical Diseases, London School of Hygiene and TropicalMedicine, London, UK11UNC Project-China, 2 Lujing Road, Guangzhou, China*The I-SHARE Team includes the following in-country leads and working group leaders: NoorAni Ahmad (Institute of Public Health, Malaysian Ministry of Health), Nathalie Bajos(INSERM), Peer Briken (University Medical Center of Hamburg), Sharyn Burns (Curtin

University), Soraya Calvo (University of Oviedo), Pheak Chhoun (Khana Center for PopulationHealth Research), Corina Iliadi-Tulbure (State University of Medicine and Pharmacy NicolaeTestemitanu), Stefano Eleuteri (Sapienza University of Rome), Joel Francis (Univeristy ofWitwatersrand), Amanda Gabster (Instituto Conmemorativo Gorgas de Estudios de la Salud),Peter Gichangi (Technical University of Mombasa), Wanzahun Godana (Arba MinchUniversity), Alejandra Gomez (Universidad de la República, Faculty of Psychology), RaquelGomez Bravo (University of Luxembourg), Sally Griffin (ICRH-Mozambique), AramHakobyan (Yerevan State Medical University), Jacqui Hendriks (Curtin University), Gert M.Hald (University of Copenhagen), Devon Hensel (Indiana University), Felipe Hurtado-Murillo(University Hospital Valencia), Olena Ivanova (Munich University), Elizabeth Kemingisha(Mbarara University of Science and Technology), Samuel Kimani (University of Kenya),Katerina Klapilova (International Congress of Psychology), Lucia Knight (University of theWestern Cape), Gunta Lazdane (Riga Stradins University), Wah Yun Low (University ofMalaysia), Ismael Maatouk (Clemeceau Medical Center), Kristen Mark (University ofKentucky), Michael Marks (London School of Hygiene and Tropical Medicine), CarolineMoreau (Johns Hopkins University), Chelsea Morroni (University of Botswana), Filippo MariaNimbi (Sapienza University of Rome), Pedro Nobre (Porto University), Viola Nilah Nyakato(Mbarara University of Science and Technology), Caitlin Alsandria O’Hara (NationalUniversity of Singapore), Carles Pericas (University of Ghent), Adesola Olumide (Universityof Ibadan), Gabriella Perrotta (Buenos Aires University), Rocio Murad Rivera (ProfamiliaColombia), Juan Carlos Rivillas (Profamilia Colombia), Eusebio Rubio-Aurioles (UniversidadNexum de México), Osama Shaeer (Kasr El Aini Faculty of Medicine), Simukai Shamu(University of the Witwatersrand), Jérôme Somé (University of Ouagadougou), Jenna Strizzi(University of Copenhagen), Rayner Kay Jin Tan (National University of Singapore), KunTang (Tsinghua University), Weiming Tang (Southern Medical University), MarleenTemmerman (Aga Khan University), and Bernardo Vega (University of Cuenca), Edwin

Wouters (Antwerp University).Corresponding author: Joseph D. Tucker, Division of Infectious Diseases, Department ofMedicine, University of North Carolina at Chapel Hill, Chapel Hill, USA,jdtucker@med.unc.eduWord count: 2350 words**IN PRESS AT SEXUALLY TRANSMITTED INFECTION**AbstractBackground: COVID-19 may have a profound impact on sexual health, reproductive health,and social life across the world. Shelter in place regulations that have extended across the globemay influence condomless sex, exacerbate intimate partner violence, and reduce access toessential reproductive health services. Population-representative research is challenging duringshelter in place, leaving major gaps in our understanding of sexual and reproductive healthduring COVID-19. This International Sexual Health And ReproductivE (I-SHARE) studyprotocol manuscript describes a common plan for online national surveys and globalcomparative analyses.Methods: The purpose of this cross-sectional study is to better understand sexual andreproductive health in selected countries during the COVID-19 pandemic and facilitate multinational comparisons. Participants will be recruited through an online survey link disseminatedthrough local, regional, and national networks. In each country, a lead organization will beresponsible for organizing ethical review, translation, and survey administration. Theconsortium network provides support for national studies, coordination, and multi-national

comparison. We will use multi-level modelling to determine the relationship between COVID19 and condomless sex, intimate partner violence, access to reproductive health services, HIVtesting, and other key items. This study protocol defines primary outcomes, pre-specifiedsubanalyses, and analysis plans.Conclusion: The I-SHARE study examines sexual and reproductive health at the national andglobal level during the COVID-19 pandemic. We will use multi-level modelling to investigatecountry-level variables associated with outcomes of interest. This will provide a foundation forsubsequent online multi-country comparison using more robust sampling methodologies.Keywords: online, COVID-19, sexual health, reproductive health, HIV, globalKey messages: Sexual and reproductive health research in the COVID-19 era is essential, butpopulation-based household sampling methods are constrained because COVID-19measures. This International Sexual Health And ReproductivE health (I-SHARE) study protocoldescribes a cross-sectional online study to better understand sexual and reproductivehealth in selected countries during the COVID-19 pandemic and facilitate multi-nationalcomparisons. Global research studies, especially in low and middle-income countries, are necessary tounderstand how COVID-19 measures may influence factors such as condomless sex,access to reproductive health services, and intimate partner violence. Further multi-country research may be helpful for enhancing sexual and reproductivehealth research during COVID-19 measures.

IntroductionThe global COVID-19 pandemic has ushered in restrictive social measures that are importantfor its control. However, shelter in place, self-isolation, quarantine, and cordon sanitairemeasures could each have a profound influence on sexual and reproductive health. Forexample, COVID-19 measures may decrease the number of pregnant women delivering inhospitals,1 delay care-seeking,2 and increase intimate partner violence.3 Restrictions inmovement, social isolation, and increased social and economic pressures will likely increase therisk of intimate partner violence in the COVID-19 era.3 Evidence from other public healthemergencies (e.g., infectious disease epidemics, wars and humanitarian disasters)4-6 suggeststhat many women are unable to obtain family planning services in order to avoid unwantedpregnancies. The Guttmacher Institute has noted that several countries have reduced or stoppedprovision of sexual and reproductive health services due to COVID-19, interrupting supplychains for condoms and other contraceptives.7 8 Women who do become pregnant during thisperiod may be at greater risk of adverse outcomes, including stillbirth, spontaneous abortion(miscarriage), and small for gestational age.9 In addition, the re-orientation of health systemstowards COVID-19 will have unintended consequences for other health services.2 For example,the 2014-2015 Ebola epidemic reduced access to healthcare services and may have exacerbatedHIV mortality rates in Guinea, Liberia and Sierra Leone.10COVID-19 also creates unique challenges for population-based behavioral research.11 Manyresearch institutes are closed and both national and international travel is restricted. While somesingle country studies of COVID-19 focused on sexual and reproductive health have beenorganized, none have been coordinated in a way that allows for multi-country analyses. Multicountry analyses are important for the following reasons: single country studies are unable toprovide insight about regional and higher-level trends in sexual and reproductive health;

country-level variation in shelter in place policies between countries can be empiricallyexamined; and multi-country data allow an examination of whether cross-national variation insexual and reproductive health results from differences in the composition of the populations orfrom differences in the context (e.g., COVID-19 measures).Responding to this gap in the literature, our team designed an online, multi-country sexual andreproductive health research study. This study is part of a project called the InternationalSexual Health And REproductive Health in the times of COVID-19 (I-SHARE). The purpose ofthis open science project is to bring together a diverse group of sexual health researchers inorder to harmonize sexual and reproductive health survey instruments and faciliate globalcomparison. The project includes interdisciplinary working groups focused on coordination,data analysis, survey development, digital technology, and survey promotion. The I-SHAREproject will allow us to examine whether measures implemented by the government will heavean effect on sexual health outcomes above and beyond individual characteristics. This studyprotocol manuscript describes a common plan for online national surveys and globalcomparative analyses.MethodsGoal and aimsThe overall goal of this global study is to better understand sexual and reproductive healthamong adults during the COVID-19 pandemic using an online convenience sample fromselected countries. The primary study aims are :1) To examine changes in sexual risk behaviors (especially condomless sex) related to the

initiation and resolution of COVID-19 measures using a multi-country analysis.2) To examine changes in intimate partner violence related to the initiation and resolutionof COVID-19 measures using a multi-country analysis.3) To examine changes in access to essential reproductive health commodities and services(e.g., contraceptives, abortion services) related to the initiation and resolution ofCOVID-19 measures using a multi-country analysis.Secondary study aims including the following:1) To examine changes in HIV/STI testing related to the initiation and resolution ofCOVID-19 measures using a multi-country analysis.2) To examine changes in harmful cultural practices (e.g., female genital mutilation, childmarriage) related to the initiation and resolution of COVID-19 measures using a multicountry analysis.3) To examine changes in mental health and other optional secondary outcomes (e.g.,nutritition) related to the initiation and resolution of COVID-19 measures using a multicountry analysis.We will use a cross-sectional online survey with convenience sampling in each country.National sample sizes will be calculated based on national priorities and analyses.Our collaborative research team brings together two groups - the Academic Network for Sexualand Reproductive Health and Rights Policy (ANSER) led by the University of Ghent andpartner institutions; and a team within the London School of Hygiene and Tropical Medicinewho worked in partnership with the Human Reproduction Programme at the World Health

Organization to develop a standardized sexual health survey instrument for use in diverseglobal settings. Investigators in the following countries are piloting online surveys in theirrespective countries: Armenia, Argentina, Australia, Botswana, Cezch Republic, Canada,China, Colombia, Denmark, Ecuador, Egypt, Ethiopia, France, Germany, Italy, Kenya, Latvia,Lebanon, Luxembourg, Malaysia, Mexico, Moldova, Mozambique, Nigeria, Panama, Portugal,Republic of Moldova, Singapore, South Africa, Spain, Sweden, Uganda, Uruguay, and theUnited States. A full list of research institutes is available online.12 The in-country lead in eachcountry will have first access to national data and make final decisions about data sharing. Eachin-country lead will make preparations for dissemination. The survey link will be available forbetween two and four weeks. People from outside of selected countries will be excluded.Survey developmentThe survey instrument has the following sections: socio-demographics; compliance withCOVID-19 social distancing measures; couple and family relationships; sexual behavior; accessto contraceptives; access to maternal healthcare; abortion; sexual and intimate partner violence;HIV/STI female genital mutilation/cutting and early/forced marriage (optional domain); mentalhealth (optional domain); and nutrition (optional domain).In each country, the lead organization will select networks through which to disseminate thelink to the survey. The survey link will be distributed through email listservs, local partnerorganizations affiliated with ANSER, other sexual and reproductive health networks, and socialmedia links. Final decisions about incentives will be made by the in-country lead and thesurvey will take approximately 15-20 minutes to complete.

The survey development was a collaborative effort of all partners in the project and was partlybased on existing questions and scales, and partly on newly developed questions. The fullsurvey instrument is included as Supplement 1. The network will centrally program the onlinesurvey questionnaire using Open Data Kit software (version 1.16). This will be an onlinesurvey self-administered through smartphones, tablets or computers.In each country, the in-country lead will organize translation, local field testing, and ethicalreview. Translation will ensure that the survey is available in the national language of thecountry and other relevant languages. Field testing will provide the survey instrument in a printform to at least 10 individuals and have them provide feedback about translations, coveringsensitive topics, and preambles. Further field testing in digital form among 5-10 potentialparticipants per country will be used to iteratively examine errors in skip logic. We estimatebetween 1-4 rounds of iteration per country survey to finalize content. We anticipate that paperbased field testing will finalize the core survey instrument structure and digital field testing willfinalize each country survey instrument. Details of the digital field testing are available assupplemental material.Inclusion criteria for the survey include 18 years or older (or younger if country IRBs andethical regulations permit and the in-country lead can ensure appropriate procedures), currentlyresiding in one of the participating countries, and able to provide online informed consent. Wewill include standard fraud protection methods, including CAPTCHA and measure to preventmore than one response from a single IP address (in countries where this is available).

Safety considerationsThis research study will present no greater than minimal risk to participants. At the same time,this survey will include several questions that are sensitive in many local settings, includingquestions about sexuality, sexual behavior, abortion, and intimate partner violence. Theparticipant will be allowed to stop the survey at any point and leave out questions that they donot wish to answer. We will not collect participant names or any other identifiers. Country-leveldata will only be able to be accessed by in-country leaders who have final decisions about useof data. Data sharing agreements will be signed between participating country institutions forcross-country analyses. National resources for intimate partner violence, sexual health services,and reproductive health services will be provided at the end of the survey.Data analysis planThis statistical analysis plan focuses on the multi-country comparison component of theanalysis. Only survey data that meet the following criteria will be included in the multi- countrycomparison: at least 200 participants, IRB approval from the local authority, description ofsampling methodology, local instrument translated and field tested.Primary AnalysisSocio-demographics will be summarized using descriptive statistics. The multi-country analysiswill use multi-level modelling to examine individual-level and country-level variablesassociated with primary outcomes , including sexual behaviors, intimate partner violence, andaccess to reproductive health services. Primary outcomes are further specified in supplementarymaterial. We will use MlwiN 3.05, a software program used in multilevel modelling

(http://www.cmm.bristol.ac.uk/MLwiN/). The general form of the two-level random interceptsmodel used to predict the proportion of participants with condomless sex (Specific Aim # 1)will be of the form:logit (πi) log [ πi / (1- πi )] β0j β1xij β0j β0 u0jThis is a binomial logistic multilevel model with random intercepts, and the binary response yijequals 1 if the individual i in country j had condomless sex. There is a single explanatoryvariable in this example, xij. The intercept consists of a fixed component β0 and a countryspecific component, the random effect u0j. Similar models will be created to estimate intimatepartner violence and access to reproductive health services. Data on country-level indicatorswill be collected from the WHO and publically available databases.13 Several of our countrylevel data come from the Oxford COVID-19 Government Response Tracker (OxCGRT), anopen access database with detailed data on 17 COVID-19 indicators in 180 countries.14 TheOxCGRT has created several indices derived from 17 indicators and report a number between 1and 100 to reflect the level of government action. We will focus on the following country-levelfactors: overall government response (OxCGRT), containment and health index (OxCGRT),economic support index (OxCGRT), stringency of lockdown index (OxCGRT), number ofCOVID-19 per 100,000 population, public insurance, and estimated excessive mortality whencompared to the year prior.

When level-2 sample size is insufficient (e.g., female genital mutilation, early marriage) toperform a multilevel analysis, cross-country differences will be determined through a fixedeffects model with country as a covariate.Given that online sampling has its own inherent biases,15 we will use propensity score matchingin some cases. Propensity score methods can be used to reduce coverage error and make websurvey samples more closely approximate population-representative samples.16 17 Propensityscore methods have been used to make groups more comparable based on covariarates.18 Giventhat we also cannot randomly assign study participants to the stringency of lockdown measures,a key covariate, propensity score methods can help us to make more accurate estimation of theassociations between COVID-19 and our primary outcomes. We will also provide moredetailed descriptions of the specific country context and COVID-19 response whereappropriate.Subgroup analysesWe will combine data from different countries in order to conduct subanalyses on the followinggroups of individuals: people living with HIV infection, pregnant women, younger individuals(under 25 years old), individuals under 18 years old (if possible), people living in low-incomecountries comapred to peo

Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium 2 . Academic Network for Sexual and Reproductive Health and Rights Policy (ANSER), Ghent, Belgium 3 Department of Womens and Childrens Health, Karolinska Institutet, Stockholm, Sweden 4 Department of Womens and Childrens Health, Uppsala University, Stockholm, Sweden

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