Review of the Published Literature on Malaria Diagnostics, Consumer Demand, and Public

Review of the published literature on malaria diagnostics, consumer demand, and public and private sector providers in Uganda

Key Insights

October 5, 2012

JHU·CCP

Contents

Summary

Background and Methods

Misdiagnosis in Uganda

Nankabirwa. Malaria misdiagnosis in Uganda – implications for policy change (2009)

Isengoma. Accuracy of malaria rapid diagnostic tests in community studies and their impact on treatment of malaria in an area with declining malaria burden in north-eastern Tanzania (2011)

Uganda Malaria Indicator Survey (2009)

Hume. Household cost of malaria overdiagnosis in rural Mozambique (2008)

Yuckich. Cost Savings with Rapid Diagnostic Tests for Malaria in Low-Transmission Areas: Evidence from Dar es Salaam, Tanzania (2010)

Provider, community and private sector insights

Asiimwe. Early experiences on the feasibility, acceptability, and use of malaria rapid diagnostic tests at peripheral health centres in Uganda-insights into some barriers and facilitators (2012)

Chandler. Introducing malaria rapid diagnostic tests at registered drug shops in Uganda. (2012)

Chandler. How can malaria rapid diagnostic tests achieve their potential? A qualitative study of a trial at health facilities in Ghana (2010)

Cohen. Prices, Diagnostic Tests and the Demand for Malaria Treatment: Evidence from a Randomized Trial (Kenya) (2010)

Cohen. Adoption of over-the- counter malaria diagnostics in Africa: T he role of subsidies, beliefs, externalities, and competition. (2011)

Hansen. Willingness-to-pay (WTP) for a rapid malaria diagnostic test and artemisinin-based combination therapy from private drug shops in Mukono district, Uganda (2012)

Harvey. Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training (2008)

Kyabayinze. Use of RDTs to improve malaria diagnosis and fever case management at primary health care facilities in Uganda (2010)

Masanja. Increased use of malaria rapid diagnostic tests improves targeting of anti-malarial treatment in rural Tanzania: implications for nationwide rollout of malaria rapid diagnostic tests (2012)

Mukanga. Community acceptability of use of rapid diagnostic tests for malaria by community health workers in Uganda(2010)

Mukanga. Access, acceptability and utilization of community health workers using diagnostics for case management of fever in Ugandan children: a cross-sectional study (2012)

Summary

Background

Malaria in Uganda is not as prevalent as once thought. In accordance with previous policies, caregivers and providers both tended to assume that fevers were malaria and treated cases as such. This results in much misdiagnosis. In 2009, over-diagnosis of malaria was as high as 79% and as much as 49% of children under 5 were under-diagnosed. In the same year, only 17% of children under five with fever received a test for malaria. To ensure appropriate care for patients, Uganda has instituted a new policy in 2012 saying all patients should be tested first.

Data from other countries show that the benefits of testing prior to treatment for households, for now, appear to be primarily non-monetary. Households who are wrongly diagnosed with malaria tend to have more provider visits and are thus more likely to miss work. The poorest households are the most disproportionately affected. While households can save money in drugs by taking a test, these savings do not necessarily offset the cost of the test. Key benefits for households may include reduced loss of productivity and reduced risk of complications. Key benefits for the health sector include reduced waste of ACTs and reduced risk of developing ACT resistance.

Providers

Facilitators

Perception that tests boost patient satisfaction and willingness to come to health center/provider
Perception that tests are easy and fast
Perception that tests facilitate their diagnosis

Barriers

Lack of ancillary supplies
Lack of clear guidelines on how to manage negative test results
Lack of support supervision
Fear of missing a malaria case that could become severe, made harder by inability to follow-up on patients except when they see them again in the community or through a follow-up visit
Perceived by community members as rude and poorly stocked with drugs.
Demand for malaria diagnosis and antimalarials or commodities by patiehts
Fear of being perceived as less competent when patient “knows” he has malaria

Adaptive behaviors to challenges from parasite-negative patients or from self to adhere to results:

Develop good rapport with patient
Explain test result and tell patient there are other explanations for the symptoms
Provide analgesics or vitamins instead of antimalarials
Consultation with other providers

Recommendations (in addition to addressing the facilitators and barriers mentioned above):

Address consumer concerns about parasite-negative results so that communities do not lose trust in the provider when a child dies.
Clinicians should be supported incontinuing to respond to the complex social context of their workincluding to the patient’s “psychological needs” as a whole.
Raise consciousnessamongst clinicians of the reasons for and consequences of certainpractices, such as providing‘placebo’tests or drugs
Equip clinicians with skills to communicate with patients in order to elicit their specific needs, for example to understand the meaning of a negative malaria test result, and to respond to these without reliance on the use of commodities.

Private sector

Facilitators

Perception from community that they are more accessible or have a more equal footing to negotiate care.

Barriers

Perception from public sector that drug shops provide dangerously poor quality care.
Low willingness to pay by consumers
Perception from private sector that tests would decrease profits from sales of ACTs

Recommendations (in addition to addressing the facilitators and barriers mentioned above):

Public health sector and officials participate in the training and quality assurance of drug shops.
Public health sector support for roles of drug shops and health workers both.
Provision of subsidies and/or bundling RDTs and ACTs.
Increase competition among retailers

Consumers

Facilitators

Willing to try test and wait for result.
Among higher SES and younger individuals, slightly more willing to pay for test
Preference for reliable stocks and good relationships found with drug shop vendors
See tests as a way to get “proper treatment.” [except when they disagree with the presumed diagnosis; it can be interpreted as “sees tests as a way to confirm presumed diagnosis.” ]
No major fears or concerns about blood when community engagement and good interactions with health workers occur.
Appreciation for health workers when they use tests or counsel and examine them

Barriers

Preference for malaria diagnosis
Fear of missing a malaria diagnosis, just in case
Practice of finding the right diagnosis through experimentation with treatments; the treatment that worked indicates what kind of disease it was.
Lack of knowledge about new policy and RDTs (thus lack of knowledge on the right way to handle negative diagnoses)
Feel justified in rejecting negative test results (perhaps since they made effort to come to clinic)
A small proportion fear pain of finger prick
Feel comfortable requesting, and getting, incomplete doses from private sector
Wary of travel or financial costs associated with getting the test

Recommendations (in addition to addressing the facilitators and barriers mentioned above):

Raise awareness on current state of misdiagnosis in Uganda.

Background and Methods

This literature review was commissioned to support the development of Stop Malaria’s Test and Treat Campaign. The behavior change communication campaign will seek to boost testing and treatment within 24 hours of fever onset. Key audiences for the campaign include: formal health providers, drug shop vendors, caregivers of children under 5, and general consumers.

A search of the published literature using Google Scholar was conducted. Search terms included rapid diagnostic tests, malaria diagnosis, consumers, community, health workers, health providers, drug shops, retail and private sector, among others.

Studies thought to have relevance in terms of formative research for the BCC campaign were purposively selected. All publications are from Uganda, with several exceptions. A few studies from other countries were included because they had potentially relevant insights.

This was not a systematic review (for example it would not pass Cochrane or PICOS standards). As a result, it is intended to provide insights on key factors affecting uptake and adherence to rapid diagnostic test results. It is not intended to be an exhaustive summary of the literature.

Misdiagnosis in Uganda

Nankabirwa. Malaria misdiagnosis in Uganda – implications for policy change (2009)

The traditional view of Uganda as a very high malaria endemic area where most of fevers are due to malaria is unlikely to be true. A large majority of outpatients, across all age groups and transmission areas, with the exception of children below five years of age in very high transmission areas, do not have malaria parasitaemia.
Only 17–25% of patients above five years of age were parasitaemic. The overall prevalence rate of 44% was higher in children below five; however, this rate did not exceed 54% even in the areas historically described as having the highest EIRs in the world. Thus, in nearly all studied populations, the majority of patients present to outpatient facilities without malaria parasitaemia.
Given the low prevalence of malaria, high frequency of fever among outpatients (79%), and current practice of presumptive diagnosis, the current rates of outpatient malaria over-diagnosis in Uganda are massive, reaching as high as 79% for patients five years and older and remaining high even in the children below five years of age in areas of highest malaria transmission (47%).
BUT there is also a large proportion (49%) of children below five years of age who are not diagnosed although parasitaemic and subsequently not treated for malaria.
Thus, there is a need for the change of policy from presumptive to parasitological-based diagnosis.

Note: Uganda updated its national malaria policy in 2012. The new policy now states that all cases suspected of malaria (which includes all fevers) should receive a test for malaria and receive the appropriate treatment. This is in line with the updated WHO guidelines for malaria case management from 2010 and WHO’s new initiative Test, Treat and Track which launched in 2012.

Isengoma. Accuracy of malaria rapid diagnostic tests in community studies and their impact on treatment of malaria in an area with declining malaria burden in north-eastern Tanzania (2011)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3145609/

The risk of false positive RDT was significantly higher in cases with fever compared to afebrile cases (OR≥2.40, p < 0.001)
Thus, with declining malaria prevalence, RDTs will identify majority of febrile cases with parasites and lead to improved management of malaria and non-malaria fevers.

Uganda Malaria Indicator Survey (2009)

52% of children under 5 have malaria. It is higher in rural areas, and highest in Mid-Northern region. Both sexes are equally likely to have malaria. In this age group, older children are more likely to have malaria. Other socioeconomic factors include: living in a rural area, having a mother with no education or primary education, and having lower income (particularly bottom 20%). All regions are significantly affected except for Southwestern region and Kampala.
76% and 98% respectively, of those living in rural and urban areas live within 5 km of a health facility. Similarly high proportions live within 5 km of a market (where other health services and drug sellers can be found).
Only 66% of mothers aged 15-49 know that a child should seek treatment within 24 hours. Mothers in rural areas and those with no or only a primary education and lower income are less likely to state this.
Only 50% of children with fever received advice or treatment within 24 hours. Children in rural areas are less likely to be brought to a health facility within 24 hours.
44% of children with fever went to a public health facility; 56% went to a private health facility. Children of less wealthy mothers are more likely to be brought to public health facilities because they are free.
Only 17% of children with fever had a diagnostic test.
Only 60% of the children who took an ACT started the treatment within 24 hours.
The most commonly cited sources of information about malaria are the radio (77%) and health providers (17%).

Hume. Household cost of malaria overdiagnosis in rural Mozambique (2008)

Adults overdiagnosedwith malaria had more repeat visits (67% v 46%, p = 0.01–0.06) compared to those with truemalaria.
A surprisingly high number of patients (53%) sought further health advice after their initial consultation and 25% of these interactions took place with traditional medicine outlets or shops rather than the clinic they had originallyattended.
There was no difference in costs betweenpatients correctly or incorrectly diagnosed withmalaria.
Median costs over three weeks were $0.28 for those who had one visit and $0.76 for ≥3 visits and were proportionally highest among the poorest (p < 0.001). It is imperative that the treatment the poorest receive is correct in order to prevent wastage of limited economic resources.
Accurate malaria diagnosis and appropriate management at primary level is critical for improvinghealth outcomes and reducing poverty.
Several studies in developing countries [about the household cost of malaria, not misdiagnosis] have shown that indirect costs (time missed from work) are around three times higher than direct costs (medications and consultations)

Yuckich. Cost Savings with Rapid Diagnostic Tests for Malaria in Low-Transmission Areas: Evidence from Dar es Salaam, Tanzania (2010)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2912577/

RDTs decreased patient expenditure on drugs (savings = U.S. $0.36; P = 0.002) and provider drug costs (savings = U.S. $0.43; P = 0.034) compared with control facilities.
However, RDT introduction did not significantly reduce patients' overall expenditures.
The RDTs reduced drug costs in this setting but did not offset the cost of the tests, although they also resulted in non-monetary benefits, including improved management of patients and increased compliance with test results.

Provider, community and private sector insights

Asiimwe. Early experiences on the feasibility, acceptability, and use of malaria rapid diagnostic tests at peripheral health centres in Uganda-insights into some barriers and facilitators (2012)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3398266/

(92%) reported a belief that a positive mRDT result was true.
Of the same health workers, only 49% believed that a negative mRDT result was truly negative.
57% (36/63) reported failure to regularly perform the test due to programmatic constraints, such as lack of ancillary supplies , heavy workload , inadequate staffing, and unclear national guidelines
Without adequate clean tap water at the HCs, health workers were expected to perform mRDTs on patients with soiled fingers without the means to clean them properly.
We provided cotton wool to supplement the small and thin alcohol swabs supplied with the mRDT. One swab was not sufficient to clean patients’ soiled hands, which can be common in rural agricultural settings
It was common for health workers not to have a wristwatch or wall clock to time the testing process, and yet they were trained to use a timer for the process.
74% (47/63) of all health workers thought it wasteful to change gloves from one patient to the next.
Health workers reported enthusiasm to use mRDTs on a daily basis and felt that mRDTs were relevant tools for fever case management. “With blood tests, we can now confidently tell that the patient is not suffering from malaria.’
Health workers felt that health centre attendees had more confidence and respect in them because of their capacity to perform the test. “The community now has confidence in us and the services we offer because of the RDTs.”
The proportion of health workers that did not prescribe ACT or non-ACT anti-malarials to patients testing negative or ‘slightly’ positive, gave folic acid, multivitamins, or analgesics. This category of health workers reasoned that they were saving ACT for those who were mRDT positive and still meeting the expectations of patients who insisted on getting a treatment for their complaints.
mRDTs were found to be acceptable to and used by the target users, provided clear policy guide lines exist, ancillary tools are easy to use and health supplies beyond the diagnostic tools are met. Based on our results, health workers ’ needs for comprehensive case management should be met, and speci fic guidance for managing febrile patients with negative test out comes should be provided alongside the new health technology.
94% (977/1035) of HC attendees who completed the interviews were willing to have a mRDT performed on them or their children.
(59%) who were willing to take a blood test believed that they were justified to challenge or reject a negative mRDT result if it was not associated with a drug prescription. “‘I like the idea of taking a blood test, but I still need to get treated even if the test says I have no malaria. Would I have come to the clinic if I was healthy?”
99% (of those willing to take the blood test) said they were willing to wait for the mRDT result if they had to.
Lack of confidence in the mRDT result, dissatisfaction with the decision of the health worker not to give malaria treatment, or fear of the pain of the finger prick were the main reasons for reluctance to have a test done. Some patients considered testing as a waste of time, or perceived the test results as false, preferring to believe that malaria was the cause of the febrile illness.

Conceptual framework for health worker and patient acceptance of RDTs

Learnability: ability of the health worker to understand how to correctly perform the mRDT, a new health technology, and accurately read the test results.
Willingness: health worker intention to carry out a blood test each time it is necessary, wait for the results, and prescribe medication (or not) in line with national guidance and test results. Regarding the HC attendee, willingness was defined as HC attendees’ intention to have the test performed on themselves or their child, wait for test results, and take medication (or not) in line with the test results.
Suitability: health workers’ belief that the test is relevant for his/her work and that test results are a true indication of the presence or absence of malaria parasites. Regarding HC attendees, suitability was defined as HC attendees’ belief that the test is relevant in determining whether or not they or their child has malaria.
Satisfaction: a health worker’s feeling that the test is convenient to perform and that it is a process he/she likes doing. Regarding the HC attendee, suitability was described as feeling that a test is convenient to take and that it is a process they would like to carry out again. It also refers to the ease-of-use of the mRDT, which is affected by the design of the mRDT, its labelling, and instructions.
Efficacy: that the health worker is able to make the effort and time to perform a test, read, interpret, and record test results, as well as prescribe medication in line with the test results, as part of their daily routine work.
Effectiveness: that the enabling organisational and supporting systems, such as training, supervision, job aids, supplies, medicines, space, lighting, timers, storage, and disposal are present or carried out and are integrated into existing routine systems.

Chandler. Introducing malaria rapid diagnostic tests at registered drug shops in Uganda. (2012)

(not publicly accessible, see attachment)