Despite effective way to improve the availability and price

Despite control efforts, malaria remains
the leading cause of death in Uganda, with approximately 8-13 million episodes reported
by the Ministry of Health each year 1. A 2009 national malaria indicator survey revealed that 45% of
Ugandan children were infected with malaria parasites, revealing the group that
carries the vast majority of this burden 2. Although four species of malaria are present, Plasmodium falciparum predominates in Kampala, accounting for over 95%
of cases3,4. Progress has been made to reduce the intensity of malaria
transmission in Uganda by implementing key control measures including insecticide
treated nets (ITNs), indoor residual spraying (IRS) and the recommended use of ACTs
as first line treatment 1. However, this progress has slowed in recent years and numerous obstacles
need to be overcome to reach the ambitious targets in malaria reduction set by
governments and international organisations5,6.

 

The public health care facilities in
Kampala are limited and face difficulties including staff shortages, drug stock
outs and long waiting times 7. This has resulted in the majority of the population relying on the
private sector to provide treatment1,8–10. The government in Uganda is now trying to strengthen the links
between the private and the public sectors, with the aim of improving access to
health care across the country 11. The Affordable Medicines Facility-malaria (AMFm) initiative
launched in 2010 and aimed to increase the availability of affordable and
quality assured medicines by introducing subsidised ACTs across seven countries
12.  The scheme was successful
and showed that, when coupled with comprehensive communication campaigns,
subsidies can be an effective way to improve the availability and price of key
medicines 12.

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Justification
for chosen strategy:

 

Whilst the AMFm programme has been
successful in improving access to ACTs across the country, they are frequently
prescribed without parasitological confirmation of malaria8,9,13–15. This is despite the WHO Global Malaria Programme releasing revised
guidelines in 2010 recommending diagnostic confirmation prior to treatment of
all suspected malaria cases16,17. The improper use of ACTs not only results in inappropriate
treatment of fever but also increases the selective pressure for resistance in
parasite populations and limits ACT availability for those that require them15,18,19. Given that up to 80% of fevers in Uganda are reportedly treated in
the informal and private sectors 1, there is a lack of access to diagnostic tools 20. Demonstrating this, a 2012 study showed that out of febrile
children receiving treatment in the private sector, only 10.3% were given
appropriate care 8. To ensure proper case management and reduce the overuse of ACTs, there
is an urgent requirement to provide the private sector with the tools to diagnose
potential malarial episodes. Rapid diagnostic tests (RDTs) are a quick,
affordable and accurate way to ensure appropriate treatment, without the need
for special laboratory equipment or extensive training 14.

 

A study in central Uganda showed that the
implementation of subsidised RDTs was successful in decreasing the use of ACTs,
with the proportion of febrile patients receiving appropriate treatment
increasing from 33.7% to 72.9% 15. In addition to this, behavioural studies looking at the
introduction of RDTs into registered drug shops have shown that clients welcomed
the availability of diagnosis and the drug-vendors embraced the ability to
demonstrate a new technical skill 11. RDTs, by encouraging the use of legal registered drug stores would
also assist in integrating them into the hierarchy of the formal health care
system11,21. Furthermore, the administration of ACTs only to confirmed malaria cases
may help to strengthen the public trust in the drugs and encourage their proper
use 22. It has been demonstrated that the introduction of RDTs into the
private sector in Kampala is feasible and welcomed by the community11,18,23,24. However it has also been shown that the RDTs must be highly
subsidised as the price that a consumer was willing-to-pay was lower than
end-user prices 25. It is clear that improved access to diagnostics in the private
sector will be hugely beneficial for those who have limited access to public
health care facilities 26.

 

Intervention
details:

 

Objectives:

·     
Increase community awareness of
RDTs as a reliable method of diagnosing malaria and of their availability in
registered drug stores in Kampala

·     
Increase the percentage of
fevers diagnosed by mRDTs in the private sector in Kampala

 

The programme will aim to work in
collaboration with the Ugandan government to ensure the possibility of
long-term continuation 18. A temporary regulatory waiver will need to be acquired to permit
the sale of mRDTs in the private sector16,18. This intervention does not include a plan for immediate policy
change however we hope to gather sufficient evidence to support a change in the
future.

Given that nearly all malarial episodes in
Kampala are caused by Plasmodium falciparum,
the RDT chosen for use in the programme is the CareStart™
Malaria HRP2(Pf) antigen detecting device 18,27. The test sensitivity, stability
and ease of use have all been considered when choosing which test to use and
all production lots will be tested to ensure good procurement practice16,27. The recommended
retail price will be USD $0.40, this is set in reference to the cost of
subsidised ACTs using data from previous trials18,25,28.

Licensed drug shops in Kampala must fulfil minimum requirements and are inspected
periodically by the District Assistant Drug Inspector (DADI) for the renewal of
their license 15. This makes these
stores particularly suitable for the control intervention. In an initial planning period, they will be
mapped using GIS and data will be collected on the numbers of febrile patients currently
seeking treatment within them. This will both allow the quantification of the volume
of RDTs required and give baseline figures from which to compare the outcomes
of the intervention to.

The drug store vendors (DSVs) will then be
invited to attend a compulsory training scheme to qualify for selling the subsidised
RDTs in their stores. The training will be carried out by senior project staff
and the district health coordinator and last for two days. This is a compromise
between the time required to deliver comprehensive training and the time that
DSVs will be willing to sacrifice, given that these are days that they will be
unable to work 11,23,24,29,30. The training will be based on guidelines from the WHO 31 and UNITAID 18 and include:

·     
Recognising signs and symptoms
of malaria.

·     
How to safely perform an RDT. The
use of gloves, single use lancets and the proper disposal of hazardous waste
material. Risks associated with unsafe use of the tests could include
transmission of blood borne diseases including HIV and hepatitis 14.

·     
How to correctly store RDTs.

·     
Stock management and record
keeping.

·     
How to accurately read the
results of an RDT. The inability to correctly interpret the RDT could result in
inappropriate management of fever and lead to fatalities.

·     
How to deal with RDT negative
patients. It has been shown that there is a lack of clarity relating to what
steps to take when an RDT is negative. This, coupled with pressure from the
customer for treatment, has resulted in an increase in antibiotic prescriptions
in some regions where RDTs have been implemented 8,13,29,32. Appropriate training on management of fevers and a referral system
to public health care facilities is necessary.

 

The training will be interactive, making
use of small group work and role-play demonstrating client interactions 15. Detailed flow charts with pictorial aids demonstrating the
appropriate course of action for positive and negative test results will also be
distributed to each store owner 23 and e-learning materials made available for future reference 18. The DSV who completed the training will be responsible for
training their employees. After the completion of this training, the store will
be accredited with an official certificate from the Ministry of Health supporting
the sale of the RDTs. In this way, the public will be aware of which drug
stores offer diagnosis and will be able to trust that they have had appropriate
training in carrying out the tests 33.

 

Following the distribution of the RDTs and
the commencement of sales, it is imperative that regular supervisory visits are
carried out to ensure their correct use and subsequent case management 1,8,11,15,23,24. These visits will be carried out by project staff monthly for the
first six months and will then be scaled back.

 

It has been shown that the introduction of
RDTs must be accompanied by social mobilisation to increase community awareness
of the tests and improve their acceptability 15,22,30,33. This will include posters, leaflets, roadside signage and community
sensitisation via meetings and church gatherings.  

 

Monitoring
and Evaluation:

 

Although the introduction of RDTs into the
private sector will be undoubtedly be hugely beneficial to many, there are also
concerns about its potential risks21,34. These include the possibility of false negative test results, under-treatment
of RDT negative patients, the prescription of antimalarials in spite of a
negative RDT and the incorrect use and disposal of hazardous waste material 8,13,14,32,34. Therefore, a comprehensive monitoring and evaluation plan is imperative
to fully determine the success of the control intervention.

 

First, there needs to be an evaluation of
the control intervention process to determine the number of DSVs that were successfully
trained and the proportion of the intended population that was reached by the behaviour
change campaigns. The proportion of DSVs that successfully completed the training
should be logged by project staff and their receptiveness and engagement to the
training should be evaluated by interviews with the participants. Cross-sectional
interviews of the population should also be carried out to determine the
community awareness of the RDTs in the drugs stores as a reliable method to
diagnose malaria. The volume and distribution of the RDTs should be closely monitored
using stocking lists and request records. There has been recent policy change
to include private sector mRDTs in a quality assurance system in Uganda18.

 

Next there should be a midterm and final proximal
outcome evaluation to determine the success of the programme in relation to its
intended objectives. There will be two primary indicators:

·     
Proportion of febrile patients
taking an mRDT at a registered drug shop in Kampala

·     
Proportion of patients testing
positive for malaria with an mRDT at a registered drug store in Kampala
receiving an effective antimalarial

 

These indicators will both be measured
using DSV patient registers and compared to the baseline data collected during
the planning phase34. There is the potential that these records may not be entirely reliable
and trustworthy therefore they must be coupled with alternative evaluation methods.

These will include the use of mystery customers and exit interviews to
ascertain whether the DSVs are using the RDTs safely and correctly and are adhering
to the results of the tests with the appropriate treatment pathway (Fig.1)34. RDT acceptability in the community will also be judged by exit
interviews and community focus discussion groups34.

 

Logistics:

 

The RDT tests will be purchased from a
manufacturer and sold onto a wholesale retailer in Kampala at a subsidised
price. The wholesaler will subsequently sell the kits exclusively to
participating shops. This will result in a large mark-up for the drug stores,
encouraging their participation and a low price for the customers. Services
including ‘cool-chain’ delivery, waste and stock management will be procured
from the same manufacturer using their in country importers and distributers 18.

 

The control
programme intervention will have an initial planning phase lasting six months,
after which there will be an 18-month intervention phase. There will be monthly
supervisory visits and monitoring for the first six months of the intervention phase
after which they will be scaled back. A midterm evaluation will occur in June
2019, 9 months into the intervention period and a final evaluation after the
full 18 months. At the end of the control intervention period a decision will be
made in collaboration with the Ugandan government about whether to continue the
programme and any changes that will need to be made.

 

 

 

The budget needs to include the cost of
purchasing the RDTs, their transport, storage, waste disposal, supply chain management,
training and supervision, community education and quality assurance.

 

 

 

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