Table 5 Outcomes, sources of data and type of analyses

Primary endpoints: Appropriate treatment

Treatment record form

The proportion of patients receiving appropriate treatment will be calculated as follows: (number of patients who are slide-positive and were given a 1^st-line anti-malarial + the number of patients who are slide-negative and not given a 1^st-line anti-malarial) divided by total febrile consultations.

Over-prescription

Treatment record form Accessibility to ACT and mRDTs

Proportion of patients who are not parasite-positive (slide-negative), who receive inappropriate ACT treatment from a drug shop, with the proportion of incorrectly treated malaria cases being based on the ‘gold standard’ of a research blood slide.

Provider adherence with mRDT result

Treatment record form

Proportion of patients who receive appropriate ACT treatment, consistent with mRDT result. Depending on the severity of symptoms an mRDT-positive patient is expected to have received either artemether-lumefantrine (Coartem) tablets or a rectal artesunate suppository.

Cost-effectiveness

Treatment record form, Implementation costs,

Incremental societal cost per additional case of appropriate treatment resulting from introducing mRDT in drug shops:

Day 14 household visits

Incremental costs of the mRDT intervention will be calculated by subtracting the societal costs in the current practice arm from the societal costs in the mRDT arm. The incremental effect will be measured as the difference in the number of cases receiving appropriate treatment (primary endpoint) in the current practice arm and the mRDT arm.

Secondary endpoints: Prompt appropriate treatment

Treatment record form

Proportion of patients seen at a registered drug shop who receive appropriate ACT treatment within 24 hours of onset of malaria symptoms

Referral: appropriate management of mRDT-negative patients

Treatment record form

Appropriate treatment of mRDT-negative patients (lack of anti-malarial sale and provision of referral.

Referral: timeliness and uptake of referral by patients

Referral forms, referral follow-up visits

Timeliness and uptake of referral at a health unit by referred patients. The mean time interval between referral and uptake for patients taking up the severe referral will be compared between arms

Patient adherence to ACT

Day 4 patient follow-up visit,

Proportion of patients followed up on day 4 that were prescribed ACT and took the full 3 day dose in the correct manner. Adherence to treatment is based on examination of the blister pack, if available, and the patient/caregivers report of how the treatment was taken during day 4 patient follow-up interview.

Equity of diagnosis

Day 14 household visits

Proportion of patients with fever receiving a diagnostic test for malaria, compared across socio-economic groups. Denominator: Households with at least one person with a history of fever within the last 14 days.

Equity of treatment

Day 14 household visits

Proportion of patients with malaria (slide-positive), receiving treatment with an ACT, compared across socio-economic groups. Denominator: Households with at least one person with a history of fever within the last 14 days.

Acceptability of mRDT to patients

Treatment record form (refusals), Day 4 patient follow-up visit, Focus group discussions

Proportion of patients with fever accepting to purchase a diagnostic test; proportion of ACT sales preceded by a positive test.

Perceptions of ACT, mRDTs and acceptability of the intervention (community, drug shops health staff)

Focus group discussions

Data from focus group discussions and key informant interviews will be transcribed and transferred to NVivo version 8 (QSR International); a software program for the management and analysis of qualitative data. Coding of the transcripts will take place through an iterative process. Initially data will be grouped into themes drawn from idea codes to generate a ‘node tree of ideas’.