- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01652365
Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector
27. juli 2012 opdateret af: Jessica Cohen, Harvard School of Public Health (HSPH)
Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda
The purpose of this study is to assess the feasibility and impact of introducing subsidized malaria rapid diagnostic tests (RDTs) into retail sector drug shops in Uganda.
This is a randomized controlled trial at the village level, taking place in 6 districts in Eastern Uganda.
Licensed drug shops in selected villages were trained in proper RDT storage, administration, interpretation and disposal and were given access to subsidized RDTs for sale.
This study explores whether drug shop owners--when given access to training and subsidized RDTs--will choose to promote and sell RDTs to customers and, if so, at what volume and what price.
The investigators also explore whether shops will safely store, administer, interpret and dispose of RDTs and to what extent they will use RDT results to guide treatment recommendations.
Finally, the study explores whether making RDTs available for sale in local drug shops has a community level impact on diagnostic testing and appropriate treatment for malaria.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2800
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Kampala, Uganda
- Clinton Health Access Initiative
-
Kampala, Uganda
- Innovations for Poverty Action-Uganda
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Drug Shops:
- Licensed and registered as a Drug Shop with the Ugandan National Drug Authority
Households:
- Live in the village of participating drug shop
- Female household head is 18 or over
Exclusion Criteria:
Drug Shops:
- Drug Shop not registered with Ugandan National Drug Authority
- Female household head is under 18
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Styring
|
|
Eksperimentel: RDT Training and Subsidy Offered
Licensed drug shops within villages selected randomly to be in this arm will be invited to training on RDTs and offered access to subsidized RDTs available for purchase at a local wholesale pharmacy in Mbale, Uganda.
|
|
Eksperimentel: Information/Education Campaign
Community meetings describing RDTs and encouraging community members to be diagnosed prior to taking malaria treatment will be held in villages randomly assigned to this treatment arm.
|
|
Eksperimentel: RDT Training/Subsidy + Information/Education Campaign
Includes both the training and subsidy component and the information/education campaign component.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fraction of Illnesses Diagnosed for Malaria
Tidsramme: Up To One Year
|
Comparison of the rate of malaria diagnosis in treatment vs. control.
Comparison will be at the village level and at the shop level.
Denominator will be: all illnesses, febrile illnesses only or suspected malaria episodes only.
|
Up To One Year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean RDT Price Charged by Shops
Tidsramme: Up to One Year
|
Up to One Year
|
|
Mean RDTs Purchased by Shops from Wholesaler
Tidsramme: Up To One Year
|
Up To One Year
|
|
Fraction of Monitoring Checklist Items Performed Correctly by Shops
Tidsramme: Up To One Year
|
Up To One Year
|
|
Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken
Tidsramme: Up To One Year
|
|
Up To One Year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jessica Cohen, PhD, Harvard School of Public Health (HSPH)
- Ledende efterforsker: Gunther Fink, PhD, Harvard School of Public Health (HSPH)
- Ledende efterforsker: William Dickens, PhD, Northeastern University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2011
Primær færdiggørelse (Faktiske)
1. juni 2012
Studieafslutning (Faktiske)
1. juni 2012
Datoer for studieregistrering
Først indsendt
24. juli 2012
Først indsendt, der opfyldte QC-kriterier
27. juli 2012
Først opslået (Skøn)
30. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. juli 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juli 2012
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 19371-106
- HS805 (Anden identifikator: Uganda National Council for Science and Technology)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Malaria
-
University of California, San FranciscoCenters for Disease Control and Prevention; University of Massachusetts... og andre samarbejdspartnereRekrutteringPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaLaos Demokratiske Folkerepublik
-
University of OxfordWellcome Trust; Ministry of public Health AfghanistanAfsluttetVivax malaria | Ukompliceret Falciparum MalariaAfghanistan
-
Medicines for Malaria VentureAsociacion Civil Selva AmazonicaAfsluttetPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaPeru
-
Menzies School of Health ResearchInternational Centre for Diarrhoeal Disease Research, Bangladesh; Addis... og andre samarbejdspartnereAfsluttetMalaria | Vivax malaria | Falciparum malariaEtiopien, Bangladesh, Indonesien
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...AfsluttetVivax malaria | Falciparum malariaIndonesien
-
Gadjah Mada UniversityMenzies School of Health Research; Eijkman Institute for Molecular Biology og andre samarbejdspartnereAfsluttet
-
London School of Hygiene and Tropical MedicineWorld Health Organization; United Nations High Commissioner for Refugees; HealthNet TPO og andre samarbejdspartnereAfsluttetMalaria | Vivax malaria | Falciparum malariaPakistan
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...AfsluttetVivax malaria | Falciparum malariaIndonesien
-
Research Institute for Tropical Medicine, PhilippinesWorld Health OrganizationAfsluttetMalaria | Vivax malaria | Falciparum malaria | Malaria Genopblomstring
-
University of IbadanShin Poong Pharm Co Ltd 161 yoksam-ro, Gangnam-Gu Seoul 135-925, Korea; Institute for Advanced Medical Research and Training, University of Ibadan, IbadanAfsluttetPlasmodium Falciparum Malaria | Ukompliceret malaria | Malaria feberNigeria
Kliniske forsøg med RDT Training and Subsidy Offered
-
Bournemouth UniversityRoyal Bournemouth and Christchurch Hospitals NHS Foundation TrustAfsluttetEffekt af træningDet Forenede Kongerige
-
VA Office of Research and DevelopmentRekrutteringSlag | BalanceunderskudForenede Stater
-
Johns Hopkins Bloomberg School of Public HealthInnovations for Poverty Action; Investors Club/Enterprise UgandaRekrutteringStress | Velvære, psykologisk | Økonomisk nødUganda
-
Kessler FoundationRekrutteringTraumatisk hjerneskadeForenede Stater
-
Children's Hospital Medical Center, CincinnatiAfsluttetAttention Deficit Hyperactivity DisorderForenede Stater
-
VA Office of Research and DevelopmentRekrutteringSkizofreni | Maniodepressiv | Depressiv lidelse, major | Stresslidelse, posttraumatiskForenede Stater
-
Queens College, The City University of New YorkAfsluttetAttention Deficit Hyperactivity DisorderForenede Stater
-
University of MichiganNational Institute on Aging (NIA)Ikke rekrutterer endnuKronisk smerte | Kognitiv svækkelse
-
University of OttawaAfsluttetUdbrændthed, professionel | Stress, følelsesmæssig | ModstandsdygtighedCanada
-
Akdeniz UniversityIkke rekrutterer endnuSundhedsfremme | Ældre mennesker