NCT01194557

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

Completed NA Last updated 11 October 2012

What this trial tests

NA trial testing Rapid diagnostic test in Fever in 2,600 participants. Completed in 1 July 2012.

Timeline

1 September 2010

Primary endpoint
1 July 2012

1 July 2012

Quick facts

Lead sponsor	DBL -Institute for Health Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	2,600
Start date	1 September 2010
Primary completion	1 July 2012
Estimated completion	1 July 2012
Sites	1 location across Uganda

Drugs / interventions tested

• Rapid diagnostic test
• Lumartem — full drug profile →

Conditions studied

• Fever — all drugs for Fever →
• Malaria — all drugs for Malaria →
• Diagnosis — all drugs for Diagnosis →
• Referral — all drugs for Referral →

Sponsor

DBL -Institute for Health Research and Development

Who can join

1 Month and older, any sex, with Fever or Malaria. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Appropriateness of treatment
  Time frame: 36 months

Sponsor's own description

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.

This 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria.
   Mbonye AK, Magnussen P, Lal S, Hansen KS, et al · · 2015 · cited 72× · PMID 26200467 · DOI 10.1371/journal.pone.0129545
2. Introducing rapid tests for malaria into the retail sector: what are the unintended consequences?
   Hutchinson E, Hutchison C, Lal S, Hansen K, et al · · 2017 · cited 22× · PMID 28588992 · DOI 10.1136/bmjgh-2016-000067
3. Introducing rapid diagnostic tests for malaria into registered drug shops in Uganda: lessons learned and policy implications.
   Mbonye AK, Clarke SE, Lal S, Chandler CI, et al · · 2015 · cited 20× · PMID 26573910 · DOI 10.1186/s12936-015-0979-6
4. Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial.
   Mbonye AK, Magnussen P, Chandler CI, Hansen KS, et al · · 2014 · cited 17× · PMID 25069975 · DOI 10.1186/1745-6215-15-303