Malaria treatment adherence and post treatment review Infections and Infestations Other parasitologically confirmed malaria
Conditions
Interventions
Caregivers of eligible children with uncomplicated malaria will be randomly assigned using the automated system to two different arms:
1. The current standard of care based on provider counselling and
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Caregivers of male and female children aged < 5 years old 2. Body weight eligibility for artemether-lumefantrine (AL) 3. Microscopically confirmed, mono-infection of Plasmodium falciparum (parasitaemia = 500/µL to 200,000/µL) 4. History of fever in the last 24 hours or presence of fever (axillary temperature = 37.5 °C) 5. Network coverage at patients? household 6. Owning a mobile phone or have shared access to a mobile phone in household 7. Ability to access a mobile phone on a daily basis for the period of follow up 8. Ability to open and read short message service (SMS) 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Caregivers not owning a mobile phone and have no shared access to any phone in the household 2. Severe malaria 3. Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand 4. Presence of concomitant illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with assessment 5. Severe malnutrition (weight for height < 70 % of the median NCHS/WHO reference) 6. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of pneumocysti carini pneumonia in children born to HIV+ women 7. Having taken AL in the previous one month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adherence to a complete AL course (doses 2-6) measured in category 3 only and defined as: a) adherent, if they present blister packs with the appropriate number of pills used and report taking the medications as recommended (± 1 hour for dose 2 and ± 2 hours for doses 3-6); b) probably adherent if they do not present blister packs but report taking the medications as recommended, c) probably non adherent if they do not present blister packs and do not report taking the medications as recommended, and d) non adherent if they present blister packs with at least one tablet not used 2. The proportion of patients in the intervention and control arms reporting to the health facility for post treatment review and subsequent evaluation of clinical and parasitological cure at day 3 (only category 1 and 2) and at day 28 (all categories) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adherence and timing outcomes for individual AL doses measured in category 1 for AL dose 2 and category 2 for AL doses 3 and 4, and category 3 for AL doses 5 and 6 2. Loss to follow up at day 3 defined as unable to return to the facility 24 hours after the scheduled appointment and loss to follow up at day 28 defined as unable to return to the facility 48 hours after the scheduled appointment | — |
Countries
Kenya
Outcome results
None listed