Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01403350 |
| Other study ID # |
5911 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
February 2012 |
| Est. completion date |
August 2012 |
Study information
| Verified date |
February 2014 |
| Source |
London School of Hygiene and Tropical Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Malaria is a common, but decreasing, cause of fever in endemic areas. The use of rapid
diagnostic tests could improve treatment of malaria at the local community level. Deployment
of these tests is, however, a considerable cost. The aim of the study is to evaluate their
effect on improving treatment of fever when used by Community Health Workers in Afghanistan.
In phase I of the study, the hypothesis is that an RDT diagnosis deployed with standard
training and support will improve the accuracy of treatment applied to fever by community
health workers when compared to a diagnosis that is based on symptoms alone. In Phase II of
the study, the hypothesis is that the accuracy of treatment can be improved by additional
training and supportive interventions given to community health workers compared to those who
have only had standard training.
Description:
This is a cluster randomised trial conducted in 22 clinics (clusters) in two provinces of
Afghanistan. Clinics in Afghanistan have a number of community health workers (CHWs) who are
residents of villages near to the clinic. The clinic provides them with their supplies of
drugs and other items (e.g. family planning interventions) and the CHW provides a range of
services in the community including treatment of acute episodes of fever. Currently, the CHW
has no way of diagnosing malaria, except based on the presenting signs and symptoms of the
patient. With this method is it likely that many patients who do not have malaria, but have a
fever, are treated with antimalarial drugs and some patients with malaria are likely not to
be treated with an antimalarial drug.
The use of Rapid Diagnostic Tests (RDT) for malaria could potentially provide the CHW with an
easy and safe way of diagnosing malaria based on the presence or absence of parasites in the
blood. However, use of tests is not straightforward. They need to be applied correctly,
following a strict protocol, to be accurate. There is now much interest in widespread
deployment of these tools which are recommended by the World Health Organisation for all
fever patients in malaria endemic areas. However, evidence for their effectiveness when used
by CHWs is patchy and there are no randomised trials that have been conducted in Asia. Since
they represent a considerable cost, examination of their effectiveness is required.
In Asia (unlike most of Africa), malaria is caused by two species - Plasmodium vivax accounts
for the majority of cases and P. falciparum for the minority. Treatments differ between the
species because of differing drug resistance patterns. Therefore accurate diagnosis is
important for providing accurate treatment for the different types of malaria and also for
treatment of cases of fever who do not have malaria with alternative treatments. In areas
where health services are restricted by short opening hours, insecurity, or inaccessibility
due to distance or terrain, the CHW should be able to use RDTs and apply the correct
treatment for both a positive and a negative test at the village level.
This study will randomise 22 clinics (and their constituent CHWs) to receive either an RDT
for use by the CHW in diagnosing malaria in patients with fever, or no intervention (the
current situation) where CHWs base their treatment decisions on symptoms alone (i.e. there is
no parasite based diagnosis). The RDT group will be given the standard national training for
use of RDTs and management of malaria and the standard supplies. The non-RDT arm will have
training on management of malaria and a short introduction to RDTs. The study will measure
the accuracy of treatment applied by the CHW in the RDT vs. the non-RDT arms, and examine the
accuracy of the RDT itself when it is applied in the field under operational conditions. The
accuracy will be measured by collecting filter paper blood spots from the patients which will
be tested by PCR for malaria. A variety of comparisons will be made between the two groups,
but the main aim is to measure and difference in accurate treatment of the patients according
to the reference (PCR) diagnosis.
In phase II of the study the non-RDT arm will be discontinued and the clinics will be
re-randomised to different interventions. One group of clinics will have the standard RDT
roll out continued, as previously, and the second group will get additional training and a
range of supportive interventions to assist in their practice. The second phase will use the
same methods of assessing the study outcomes. The aim of the second phase is to see whether
additional training (and cost) results in improved practice by CHWs.
