Randomized trial of spatially targeted malaria control to virtually eliminate malaria in areas of low and patchy transmission in Senegal.
The purpose of this trial is to evaluate the extent to which a targeted malaria control strategy combining vector control with indoor residual spraying (IRS) and chemotherapy, delivered by district health staff to villages reporting clinical cases, can virtually eliminate malaria, in an area in central Senegal where malaria incidence is very low and patchy. Secondly, to determine whether, as part of this strategy, chemotherapy should be delivered to all members of targeted communities or only those who have been tested and are known to be infected.
- To compare the effectiveness of MDA and MSAT,
- To evaluate the impact of the interventions on transmission in non-targeted areas,
- To assess the safety of MDA and MSAT with DHA-PQ,
- To assess the impact of MDA and MSAT on the prevalence of markers of resistance to DHA and PQ,
- To assess the social acceptability of the interventions,
- To assess the coverage of the interventions and adherence to drug treatment regimens,
- To determine the efficacy and duration of action of IRS with Actellic-300CS, and
- To determine the cost of the interventions.
- Drug & Regimen:
- MSAT: 2 rounds (September and November) for 2 years with dihydroartemisinin-piperaquine (DP)
- MDA: 2 rounds (August and October) for 2 years with dihydroartemisinin-piperaquine (DP)
- Mode of delivery: 1st dose DOT, door-to-door. District health staff to villages reporting clinical cases.
- Dosage was by age group: 160/20mg for three days (children aged 3-35 months); 320/40 (children aged 3-7 years months); 1.5 tablets 320/40 (children aged 8-11 years); 2 tablets 320/40 (children aged 12-14 years); and 3 tablets 320/40 (children 15 years and adults)
- Concomitant interventions: Health promotion to encourage care seeking for fever and LLINs
- Target population: 228 out of 716 villages (32%) were categorized as hotspots.
- Exclusion criteria: Pregnant women in the 1st trimester (for MSAT arm) and pregnant women any trimester (for MDA arm).
- Outcome measures:
- Incidence of malaria confirmed by RDT by passive detection in year 2
- Prevalence of parasitaemia in year 2 in the whole population
- Incidence of malaria and the prevalence of parasitaemia in non-targeted areas
- Incidence of malaria and prevalence of parasitaemia in targeted areas
- Incidence and prevalence in year 1
- Prevalence of antibodies to P. falciparum antigens (MSP1, AMA1)
- In a subset of samples, prevalence of P. falciparum by PCR
- Incidence of severe adverse events within 10 days of drug administration
- Tolerability of the interventions
- Coverage of and adherence to the interventions
- The prevalence of molecular markers associated with resistance to DHA and PQ in malaria cases and in persons with P. falciparum infection in the year 2 survey
- Costs of the interventions
- Follow-up at the beginning of the following year
Intervention model: Parallel assignment
Masking: None (open label)
Primary purpose: Treatment