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Individually Randomized Trial of Rapid Diagnostic Tests in Rural
Ghana

Introduction

The study begun in the first quarter of 2007 with baseline studies and recruitment for the main trial was completed in December 2008. Activities in the year under review will focus mainly on the last two of the five specific objectives as follows:

• To explore clinician and patient perceptions on the use of RDTs, microscopy and clinical diagnosis in the management of malaria.

• To determine the cost-effectiveness of RDTs for diagnosis of malaria in both settings.

Study Sites

Four health facilities sited in three communities participated in these two phases of the study. These were the same health facilities that were involved in the main trial.

 Microscopy (‘M’) setting – Dodowa Health Centre (DHC)

 Clinical (‘C’) setting – Agomeda Community Clinic (ACC)

 Prampram Health Centre (PHC)

 Ebenezer Private Clinic (EPC)

Data Cleaning And Analysis

The main RDT trial data was extensively cleaned and all errors rectified. The data was analyzed together with co-investigators from London School of Hygiene and Tropical Medicine. Reports were written and a paper produced for publication.

This was subsequently accepted for publication by the British Medical Journal (BMJ).

Qualitative Study

The Qualitative study which aimed at exploring both patient and clinician perceptions on the use of
RDTs, microscopy and clinical diagnosis in the management of malariawas carried out in March 2009.
This phase of the study received financial support from the ACT Consortium. A Social Scientist from the Consortium came to support this phase. Data collection for this phase involved Individual In-depth Interviews with Health Workers and Focus Group Discussions (FGDs) with community members.
The health workers who were clinicians from the study sites (health facilities) who had been involved in the recruiting patients for the main trial were interviewed by the Social Scientist. The community
FGDs also involved patients who had been recruited into the trial. They were divided into groups based on whether they were RDT negative or positive and whether they received antimalarials or not. This information was retrieved from the study database. The data was analyzed with support by the Social Scientist and a report has been written.

Cost Effectiveness Study

The cost-effectiveness phase which was aimed at determining the cost-effectiveness of introducing
RDTs for diagnosis of malaria in both settings took place in August 2009.

Data collection for the cost-effectiveness phase of the study has just been completed. The data collection involved carrying out randomization of patients as occurred in the main trial. The following were done:

• Documentation of the socio-economic status of patients receiving primary care for malaria in two settings where RDTs have been introduced: where there is microscopy and where there is none

• Documentation of both the direct and indirect costs of care in both settings

The work was supported by the two health economists who are core scientists on the ACT consortium one of who travelled to Ghana to assist in the data collection and preliminary analysis. Additional data had to be collected on time health staff allocate to laboratory tests to validate data previously collected.
For this study, only three of the four facilities that were used for the main study, the public sector facilities, were involved. Recruitment begun on 24th August 2009 and ended on 30th September 2009.

Follow-up of the patients also took place from 7th September to 14th October 2009. A mop up exercise was undertaken for one week and this ended on 21st October, 2009. The data has been cleaned and verified and is now being analyzed.