Delivery of Malaria Chemoprevention in the Post-discharge Management of Children With Severe Anaemia in Malawi (PMC)
Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-Piperaquine for the Post-discharge Management of Severe Anaemia in Children Less Than 5 Years in Malawi
Study Overview
Status
Conditions
Detailed Description
Objectives: The primary objective of the trial is to determine the optimum PMC delivery mechanism by comparing community- versus health facility-based strategies in order to inform policy.
Study Type: This is a single-centre, matched, cluster randomized, 5-arm, factorial design trial comparing the uptake of PMC-DHP delivered through health facility or community-based approaches with or without SMS/HSA reminders.
Site: 90 villages in the catchment areas of Zomba Central hospital in southern Malawi
Study Population:
Inclusion criteria: convalescent children aged less than 5 years and weighing >5 kg admitted with severe anaemia (haemoglobin<5g/dL / Ht<15%); clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL.
Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell trait, known hypersensitivity to study drug, known heart conditions, non-resident in study area, previous participation in study, known need at enrolment for prohibited medication and scheduled surgery during the course of the study. HIV infection and cotrimoxazole prophylaxis are not exclusion criteria
Study Interventions:
All children will receive Dihydroartemisinin-piperaquine (3-day treatment courses, given 2,6 and 10 weeks after discharge) either:
- at discharge + SMS Reminder;
- at discharge + No SMS Reminder;
- at discharge + HSA Reminder;
- at OPD + SMS Reminder; or
- at OPD + No SMS Reminder
Outcome Measures:
Primary: 100% of PMC drugs uptake (defined as administration of all 3-day treatment courses, given 2, 6 and 10 weeks after discharge) assessed by unannounced spot checks.
Follow-up procedures: Children will be followed up for 15 weeks by passive case detection in 2 phases: Pre-PMC (2 weeks between hospital admission and 2 weeks post-discharge); PMC (2-14 weeks post-discharge)
Sample Size: A sample size of 75 children per arm (375 total children) allows for a detection of 25% increase in uptake from 50% to 75% with 10% loss to follow-up (power 90%, α=0.05).
Data Analysis: The % of children receiving IPTpd according to schedule will be compared by relative risks (95% CI), adjusted for prognostic factors at baseline using log binomial or Poisson regression with adjustment for cluster effects
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Zomba, Malawi, 0000
- Recruiting
- College Of Medicine,Training and Research Unit Of Excellence,Zomba Central Hospital
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Contact:
- Kamija Phiri, PhD
- Phone Number: +265999957048
- Email: kphiri@medcol.mw
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Contact:
- Thandile Nkosi-Gondwe, MBBS
- Phone Number: +265995508830
- Email: tgondwe@medcol.mw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Haemoglobin <5.0g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital
- Age between 4 months (inclusive) and 59 months (inclusive)
- Body weight >5kgs
Screening (in-hospital):
- Fulfilled the pre-study screening eligibility criteria
- Clinically stable, able to switch to oral medication
- Subject completed blood transfusion(s) in accordance with routine hospital practice
- Able to feed (for breastfed children) or eat (for older children)
- Absence of known cardiac problems
- Provision of informed consent by parent or guardian
Randomization (at discharge):
- Fulfilled screening eligibility criteria
- Still clinically stable, able to take oral medication, able to feed (for breastfed children) or eat (for older children) and able to sit unaided (for older children who were able to do so prior to hospitalization
Exclusion Criteria:
- Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)
- Known sickle cell
- Child will reside for more than 25% of the 3.5months study period (i.e. 3 weeks or more) outside of catchment area Enrolment in the study (t=0) at discharge
- Previous enrolment in the present study
- Known hypersensitivity to study drug
- Sickle cell disease
- Known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.
- On-going or planned participation into another clinical trial involving on-going or scheduled treatment with medicinal products during the course of the study (3.5 months from enrolment)
- Known need, or scheduled surgery during the course of the study (3.5 months)
- Suspected non-compliance with the follow-up schedule
- Known heart conditions, or family history of congenital prolongation of the QTc interval
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Drug + short message(SMS) reminder
dihydroartemesinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with SMS reminders prior to each treatment course
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|
|
Other: Drug + no short message(SMS) reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) without SMS reminders prior to each treatment course.
|
|
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Other: Drug+ Health worker reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with Health surveillance assistants reminders prior to each treatment course.
|
Health surveillance assistants reminders prior to each treatment course
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|
Other: Drug at hospital + SMS reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department without an SMS reminders prior to each treatment course.
|
|
|
Other: Drug at Hospital+no SMS reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department with a short message reminder prior to each treatment course
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of those with 100 % uptake of PMC drugs during the 15 weeks of the study period.
Time Frame: 15 weeks
|
100 % uptake is defined as administration of all study drugs and compliance to study visits during the course of 15 weeks.
|
15 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of those with 60% uptake of PMC drugs during the 15 weeks of the study period.
Time Frame: 15 weeks
|
60 % uptake is defined as administration of 6 or more [but less than 9] of the daily dosages out of the total of 9 during the 15 week study period.
|
15 weeks
|
|
Proportion of those with 30 % uptake of PMC drugs during the 15 week trial period.
Time Frame: 15 weeks
|
30 % PMC uptake is defined as administration of 3 or more [but less than 6] of the daily dosages out of the total of 9 during the 15 week trial period.
|
15 weeks
|
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Proportion of those with <30% uptake of PMC drugs during the 15 week trial period.
Time Frame: 15 weeks
|
<30 % PMC uptake is defined as administration of less than 3 of the daily dosages out of the total of 9 assessed during the 15 week trial period.
|
15 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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All-causes of deaths and all-causes of hospital re-admissions during the 15 week trial period.
Time Frame: 15 weeks
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Assessment of all children who die or are hospitalised during the trial period
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15 weeks
|
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Assessment of the added costs of the interventions to the health system and the individual patients by conducting interviews during the 15 week trial period.
Time Frame: 15 weeks
|
15 weeks
|
|
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Assessment of how the study interventions are acceptable by patients and health workers by conducting focus group discussions and using self administered questionnaires during the 15 week trial period.
Time Frame: 15 weeks
|
15 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kamija Phiri, PhD, University of Malawi
Publications and helpful links
General Publications
- Nkosi-Gondwe T, Robberstad B, Mukaka M, Idro R, Opoka RO, Banda S, Kuhl MJ, O Ter Kuile F, Blomberg B, Phiri KS. Adherence to community versus facility-based delivery of monthly malaria chemoprevention with dihydroartemisinin-piperaquine for the post-discharge management of severe anemia in Malawian children: A cluster randomized trial. PLoS One. 2021 Sep 10;16(9):e0255769. doi: 10.1371/journal.pone.0255769. eCollection 2021.
- Nkosi-Gondwe T, Robberstad B, Blomberg B, Phiri KS, Lange S. Introducing post-discharge malaria chemoprevention (PMC) for management of severe anemia in Malawian children: a qualitative study of community health workers' perceptions and motivation. BMC Health Serv Res. 2018 Dec 19;18(1):984. doi: 10.1186/s12913-018-3791-5.
- Gondwe T, Robberstad B, Mukaka M, Lange S, Blomberg B, Phiri K. Delivery strategies for malaria chemoprevention with monthly dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years old in Malawi: a protocol for a cluster randomized trial. BMC Pediatr. 2018 Jul 20;18(1):238. doi: 10.1186/s12887-018-1199-3.
- Svege S, Kaunda B, Robberstad B, Nkosi-Gondwe T, Phiri KS, Lange S. Post-discharge malaria chemoprevention (PMC) in Malawi: caregivers; acceptance and preferences with regard to delivery methods. BMC Health Serv Res. 2018 Jul 11;18(1):544. doi: 10.1186/s12913-018-3327-z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.02/15/1679
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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