Impact of mass screening and selective treatment with dihydroartemisinin-piperaquine plus primaquine on malaria transmission in Indonesia: a randomized cluster trial
A randomized cluster trial of MSAT using dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) will be conducted in some villages at the Belu regency, Nusa Tenggara Timur province, Central Indonesia.
There will be three arms in the study:
- intervention arm of mass screening and treatment with interval of 6 weeks;
- intervention arm of mass screening and treatment with interval of 3 months; and
- control arm without mass screening and treatment.
The intervention arm with 6 weeks interval represents a new proposed method to detection malaria infections, while the intervention arm with 3 month interval represents the Ministry of Health current policy of active case detection in Indonesia, and the third arm will serve as the control for Ministry of Health's policy.
The study will be conducted in 6 months period and will evaluate various parameters including malaria incidence and proportion of anemia in monthly cohort school children (in arm 1, 2 and 3), in addition to malaria prevalence in the community (only in arm 1 and arm 2). All positive subject in all arms will receive supervised treatment.
Secondary objectives are the proportion of gametocytemia in the community, the proportion of malaria antibody of various age groups, population genetic of local parasite, submicroscopic incidence based polymerase chain reaction and the proportion of infective mosquitoes. Data analysis will be performed according to the method for cluster randomized trial evaluation.
Factors driving MSAT success include achievable coverage and screening technology diagnostic threshold. The timing and frequency of screening, therapies applied, species involved, and intensity of transmission also impact MSAT. In the Asia Pacific region, relatively lower levels of P. falciparum transmission prevail with Plasmodium vivax. This study offers a first evaluation of MSAT in a low-transmission area with P. falciparum and P. vivax.
ClinicalTrials.gov Identifier: NCT01878357
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 1488 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment