Nctid:
NCT06225739
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>2000}, "targetDuration"=>"9 Months", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-19", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-20", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Feasibility of mobile application for registration of pregnant women and tracking pregnancy outcomes", "timeFrame"=>"9 months", "description"=>"Assess whether an open-source mobile applications is easy and convenient to use accounting for advantages and disadvantages to guide integrating the App into routine workflow via qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)"}, {"measure"=>"Usability of mobile application for registration of pregnant women and tracking pregnancy outcomes", "timeFrame"=>"9 months", "description"=>"Assess whether open-source mobile applications could be used by pregnant women and health workers to adequately record, track, and summarize data, including whether it functioned in a way that enhanced productivity or led to unproductive tasks due to errors. The assessment will be done using qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)"}, {"measure"=>"Acceptability of mobile application for registration of pregnant women and tracking pregnancy outcomes", "timeFrame"=>"9 months", "description"=>"Acceptability will be defined as pregnant women and health workers and other stakeholders found the Client Data App acceptability, including its interface and navigation features. The assessment will be done using qualitative methods: In-depth interviews (IDIs) and focus group discussions (FGDs)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Pregnancy register", "Mobile application", "Pregnancy outcome"], "conditions"=>["Pregnancy Related"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"http://www.advance-vac4pm.eu/", "label"=>"Related Info"}]}, "descriptionModule"=>{"briefSummary"=>"Monitoring pregnancy outcomes during pregnancy is very important in assessing the effectiveness of interventions. This study aims to create pregnancy registers and evaluate pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in future placental malaria (PM) vaccine trials, as well as for the implementation of any other intervention in this target group.", "detailedDescription"=>"Background: Malaria during pregnancy remains a major public health problem. A consortium from Africa and Europe is further advancing the clinical development of two PM vaccine candidates (PAMVAC-cVLP and PRIMVAC). These vaccines have previously been shown to be safe, well-tolerated and able to induce a strong and functional immune response. Monitoring pregnancy outcomes during pregnancy is very important in assessing the effectiveness of interventions against PM. The increased availability of mobile phones makes them a potential tool for improving quality of care for pregnant women, accurately collecting and reporting pregnancy outcomes in identified cohorts of pregnant women. Data on the feasibility and acceptability of the mobile applications for tracking pregnancy outcomes in the areas targeted for clinical testing of candidate PM vaccines is however limited. This study will explore the creation of electronic pregnancy registers and evaluate pregnancy mobile applications as a potential tool for monitoring pregnancy outcomes in future PM vaccine trials, as well as for the implementation of other future interventions in Ghana, Burkina Faso, Benin and Malawi.\n\nOverall aim: To evaluate the feasibility and acceptability of open-source mobile applications in tracking pregnancy outcomes among pregnant women in sub- Saharan Africa.\n\nMethods: The study will be carried out in two phases. The first phase will involve the mapping of health application tools, and the selection of one of the tools for the registration of pregnancies at each of the participating sites. The evaluation process will involve a two-level test namely alpha and beta. Prior to the selection of the electronic tool, the team will define the data characteristics and requirements of the pregnancy register. This will be followed by a description of the process flow and the expected functionality of the pregnancy register including visualization and reporting of outcomes of interest. After this, specifications of the interface technologies, the database technologies, and the network requirements will be determined. Each site will create a pregnancy register using REDCap. The second phase will involve the assessment of the feasibility and acceptability of mobile application. At the evaluation phase, qualitative methods will be used to assess the feasibility and acceptability of using the selected mobile application for tracking pregnancy outcomes. The selected app will be tested by pregnant women. In-depth interviews (IDIs) and focus group discussions (FGDs) will be used to explore the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes among pregnant women. Pregnant women from rural and urban parts of the study areas who will be able to use the electronic application and are willing to participate in the interviews will be purposively selected from the pregnancy register, and health workers sampled from the health facilities.\n\nExpected outcome: The assessment of mobile applications for monitoring pregnancy outcomes and development of pregnancy registers will build the base for future PM vaccine trials and any other interventions tackling PM. If acceptability and feasibility is demonstrated, mobile applications could be linked to other tools that will provide support to front line health care workers and patients to ensure uptake and continued access to essential maternal and neonatal care services through responsive customized needs of patients in view of routine care packages."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"49 years", "minimumAge"=>"15 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Phase 1 study population will include pregnant women of all ages attending antenatal care (ANC) facility. Phase 2 study population will include pregnant women aged 15-49 years attending ANC facility and health workers who provide healthcare services to pregnant women at ANC clinics or Maternity ward", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Pregnant women attending ANC facility in the study area\n* Pregnant women whose ANC information can be accessed at the ANC facility\n* Health workers providing care to pregnant women at ANC or Maternity facilities\n\nExclusion Criteria:\n\n* Pregnant women attending ANC outside the study area\n* Pregnant women whose ANC information cannot be accessed at the ANC facility\n* Pregnant women unwilling or unable to provide informed consent"}, "identificationModule"=>{"nctId"=>"NCT06225739", "briefTitle"=>"Evaluation of Electronic Pregnancy Registers and Mobile Applications for Monitoring Pregnancy Outcomes ( EVAPREAP )", "organization"=>{"class"=>"OTHER", "fullName"=>"European Vaccine Initiative"}, "officialTitle"=>"Evaluation of Electronic Pregnancy Registers and Mobile Applications as a Potential Tool for Promoting Antenatal Care and Monitoring Pregnancy Outcomes", "orgStudyIdInfo"=>{"id"=>"EVAPREAP-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Pregnant women", "interventionNames"=>["Other: Electronic pregnancy register", "Other: In-depth interviews and focus group discussions"]}, {"label"=>"Health care providers", "description"=>"In-depth interviews (IDIs) and focus group discussions (FGDs) will be used to assess the user experience and the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes", "interventionNames"=>["Other: In-depth interviews and focus group discussions"]}], "interventions"=>[{"name"=>"Electronic pregnancy register", "type"=>"OTHER", "description"=>"Electronic pregnancy register will be created based on local ANC register to monitor pregnancy outcomes across all sites. Pregnant women of all ages attending antenatal care (ANC) facility will be registered", "armGroupLabels"=>["Pregnant women"]}, {"name"=>"In-depth interviews and focus group discussions", "type"=>"OTHER", "description"=>"In-depth interviews (IDIs) and focus group discussions (FGDs) will be used to assess the user experience and the perceptions of pregnant women and health workers on the feasibility, usability, and acceptability of open-source mobile applications for tracking pregnancy outcomes", "armGroupLabels"=>["Health care providers", "Pregnant women"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Cotonou", "status"=>"RECRUITING", "country"=>"Benin", "contacts"=>[{"name"=>"Ayola Akim Adegnika, MD, PhD", "role"=>"CONTACT", "email"=>"aadegnika@gmail.com"}, {"name"=>"Josiane Honkpehedji, MD", "role"=>"CONTACT", "email"=>"hyjosy@gmail.com"}], "facility"=>"Fondation pour la Recherche Scientifique (FORS)", "geoPoint"=>{"lat"=>6.36536, "lon"=>2.41833}}, {"city"=>"Ouagadougou", "status"=>"RECRUITING", "country"=>"Burkina Faso", "contacts"=>[{"name"=>"Alphonse Ouédraogo, MD, PhD", "role"=>"CONTACT", "email"=>"a.ouedraogo@gras.bf", "phone"=>"+22678557905"}, {"name"=>"Sodiomon Sirima, MD, PhD", "role"=>"CONTACT", "email"=>"s.sirima@gras.bf"}], "facility"=>"Groupe de Recherche Action en Santé (GRAS)", "geoPoint"=>{"lat"=>12.36566, "lon"=>-1.53388}}, {"city"=>"Kintampo", "status"=>"RECRUITING", "country"=>"Ghana", "contacts"=>[{"name"=>"Kwaku Poku Asante, MD, PhD", "role"=>"CONTACT", "email"=>"kwakupoku.asante@kintampohrc.org", "phone"=>"+233352097602"}, {"name"=>"David Dosoo, PhD", "role"=>"CONTACT", "email"=>"david.dosoo@kintampo-hrc.org"}], "facility"=>"Kintampo Health Research Centre (KHRC)", "geoPoint"=>{"lat"=>8.05627, "lon"=>-1.73058}}, {"city"=>"Mikolongwe", "status"=>"RECRUITING", "country"=>"Malawi", "contacts"=>[{"name"=>"Mwayiwawo Madanitsa, MD, PhD", "role"=>"CONTACT", "email"=>"mmadanitsa@must.ac.mw", "phone"=>"+265999616537"}, {"name"=>"Joel Kumwenda, MEng", "role"=>"CONTACT", "email"=>"jkumwenda@gmail.com"}], "facility"=>"Malawi University of Science and Technology (MUST)", "geoPoint"=>{"lat"=>-15.88756, "lon"=>35.19758}}], "centralContacts"=>[{"name"=>"David Dosoo, PhD", "role"=>"CONTACT", "email"=>"david.dosoo@kintampo-hrc.org", "phone"=>"+233 244644085"}, {"name"=>"Japhet Anim, MSc", "role"=>"CONTACT", "email"=>"japhet.anim@kintampo-hrc.org", "phone"=>"+233 208776369"}], "overallOfficials"=>[{"name"=>"Kwaku Poku Asante, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Kintampo Health Research Centre, Ghana"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"European Vaccine Initiative", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Kintampo Health Research Centre, Ghana", "class"=>"OTHER"}, {"name"=>"Fondation pour la Recherche Scientifique, Benin", "class"=>"UNKNOWN"}, {"name"=>"Groupe de Recherche Action en Sante", "class"=>"OTHER"}, {"name"=>"Malawi University of Science and Technology", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
