Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 5:07 AM
Study NCT ID:
NCT01194557
Status:
COMPLETED
Last Update Posted:
2012-10-12
First Post:
2010-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Introducing Rapid Diagnostic Tests Into the Private Health Sector
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D008288', 'term': 'Malaria'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092025', 'term': 'Rapid Diagnostic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000067716', 'term': 'Point-of-Care Testing'}, {'id': 'D019095', 'term': 'Point-of-Care Systems'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-11', 'studyFirstSubmitDate': '2010-09-02', 'studyFirstSubmitQcDate': '2010-09-02', 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appropriateness of treatment', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Appropriateness of referral of complicated malaria cases', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['history of fever', 'measured fever', 'appropriate treatment', 'appropriate referral'], 'conditions': ['Fever', 'Malaria', 'Diagnosis', 'Referral']}, 'referencesModule': {'references': [{'pmid': '21349623', 'type': 'BACKGROUND', 'citation': 'Chandler CI, Hall-Clifford R, Asaph T, Pascal M, Clarke S, Mbonye AK. Introducing malaria rapid diagnostic tests at registered drug shops in Uganda: limitations of diagnostic testing in the reality of diagnosis. Soc Sci Med. 2011 Mar;72(6):937-44. doi: 10.1016/j.socscimed.2011.01.009. Epub 2011 Feb 3.'}, {'pmid': '21176131', 'type': 'BACKGROUND', 'citation': 'Mbonye AK, Ndyomugyenyi R, Turinde A, Magnussen P, Clarke S, Chandler C. The feasibility of introducing rapid diagnostic tests for malaria in drug shops in Uganda. Malar J. 2010 Dec 21;9:367. doi: 10.1186/1475-2875-9-367.'}, {'pmid': '28588992', 'type': 'DERIVED', 'citation': 'Hutchinson E, Hutchison C, Lal S, Hansen K, Kayendeke M, Nabirye C, Magnussen P, Clarke SE, Mbonye A, Chandler CIR. Introducing rapid tests for malaria into the retail sector: what are the unintended consequences? BMJ Glob Health. 2017 Jan 11;2(1):e000067. doi: 10.1136/bmjgh-2016-000067. eCollection 2017.'}, {'pmid': '26200467', 'type': 'DERIVED', 'citation': 'Mbonye AK, Magnussen P, Lal S, Hansen KS, Cundill B, Chandler C, Clarke SE. A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria. PLoS One. 2015 Jul 22;10(7):e0129545. doi: 10.1371/journal.pone.0129545. eCollection 2015.'}, {'pmid': '25069975', 'type': 'DERIVED', 'citation': 'Mbonye AK, Magnussen P, Chandler CI, Hansen KS, Lal S, Cundill B, Lynch CA, Clarke SE. Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial. Trials. 2014 Jul 29;15:303. doi: 10.1186/1745-6215-15-303.'}]}, 'descriptionModule': {'briefSummary': 'Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, artemisinin combination therapies (ACTs) should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.\n\nThis study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by ocal drug shops in an area with high malaria transmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with fever\n* uncomplicted malaria\n\nExclusion Criteria:\n\n* Complicated malaria\n* known allergic reactions to Lumartem'}, 'identificationModule': {'nctId': 'NCT01194557', 'briefTitle': 'Introducing Rapid Diagnostic Tests Into the Private Health Sector', 'organization': {'class': 'OTHER', 'fullName': 'DBL -Institute for Health Research and Development'}, 'officialTitle': 'Introducing Rapid Diagnostic Tests Into the Private Health Sector in Uganda: a Randomised Trial Among Registered Drug Shops to Evaluate Impact on Antimalarial Drug Use', 'orgStudyIdInfo': {'id': 'ACTUGA3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rapid diagnostic test', 'description': 'Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests', 'interventionNames': ['Device: Rapid diagnostic test', 'Drug: Lumartem']}, {'type': 'NO_INTERVENTION', 'label': 'Presumptive malaria treatment', 'description': 'Presumptive treatment for malaria in drug shops'}], 'interventions': [{'name': 'Rapid diagnostic test', 'type': 'DEVICE', 'description': 'Diagnosis of malaria using rapid diagnostic test', 'armGroupLabels': ['rapid diagnostic test']}, {'name': 'Lumartem', 'type': 'DRUG', 'description': 'Presumptive treatment of malaria/fever', 'armGroupLabels': ['rapid diagnostic test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mukono', 'state': 'Mukono', 'country': 'Uganda', 'facility': 'Mukono District', 'geoPoint': {'lat': 0.35333, 'lon': 32.75528}}], 'overallOfficials': [{'name': 'Anthony K Mbonye, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Uganda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DBL -Institute for Health Research and Development', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Uganda', 'class': 'OTHER_GOV'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'Artemisinin-based Combination Therapy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Pascal Magnussen', 'investigatorAffiliation': 'DBL -Institute for Health Research and Development'}}}}