Clinical trial NCT01048801: Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria
Official title: Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria: Comparative Trials in Two Areas of High and Low Transmission in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Malaria
Keywords: History of fever
measured fever
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Uganda
name: London School of Hygiene and Tropical Medicine
name: Artemisinin-based Combination Therapy
First posted: 2010-01-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, 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.

This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by community-based drug distributors.The accuracy of RDTs, and the acceptability of this approach, will be evaluated in both low and high transmission areas.


Eligibility criteria: Inclusion Criteria:

* Children aged between 6 months and 5 years (\< 5 years)reported with fever by the mother/ caretaker of the child
* Children with uncomplicated malaria/ fever episodes
* Children whose mothers consent to participate

Exclusion Criteria:

* Children aged less 6 months or greater than 4 years (≥ 5 years)
* Children requiring referral to a health facility (severe malaria, complicated fever episode, convulsions/fits, loss of consciousness, and other danger signs)
* Children whose mothers refuse to consent

Primary outcomes:
measure: Proportion of patients given prompt effective treatment by CDDs: % of <5-year-old children diagnosed with malaria who receive appropriate ACT treatment within 24 hours of onset of malaria.
timeFrame: 36 months
Secondary outcomes:
measure: Coverage of prompt effective treatment: % of <5-year-old children with fever who received ACT treatment within 24 hours of onset of malaria, measured through household surveys.
timeFrame: 36 months
Other outcomes:
Locations:
city: Rukungiri
country: Uganda
facility: Rukungiri District
Study officials:
affiliation: Ministry of Health, Uganda
name: Richard Ndyomugyenyi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Lal S, Ndyomugenyi R, Paintain L, Alexander ND, Hansen KS, Magnussen P, Chandramohan D, Clarke SE. Caregivers' compliance with referral advice: evidence from two studies introducing mRDTs into community case management of malaria in Uganda. BMC Health Serv Res. 2018 May 2;18(1):317. doi: 10.1186/s12913-018-3124-8.