Last Updated: 04/10/2024
Community reactive case detection versus reactive drug administration in malaria elimination areas: a cluster randomized controlled trial
Objectives
The main objective of this project is to compare the effectiveness of reactive focal drug administration versus reactive focal testing and treatment in reducing malaria prevalence and incidence within Ministry of Health health facility catchments.
Secondary objectives:
- Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing rapid diagnostic test (RDT) confirmed malaria incidence through passive case detection at health facilities;
- Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing the prevalence of malaria and preventing re-infection in individuals receiving reactive responses;
- Compare the cost-effectiveness of RFDA using DHAP with RFTAT using AL in reducing the burden of malaria in the community;
- Measure the proportion of P. falciparum infections likely attributable to importation and local transmission using parasite genotyping as well as defining genotype spatial distribution;
- Assess the utility of using serology to measure short term changes in malaria transmission and evaluate malaria elimination programs; and
- Assess the feasibility of using remotely sensed malaria risk maps to identify areas with higher potential for local malaria transmission.
The performance of highly-sensitive RDTs will be evaluated in this study:
- Evaluate the feasibility of a highly-sensitive RDT in identifying additional sub-microscopic infections compared to RDT in the RFDA arm
- Measure incidence of malaria from standard RDT, highly-sensitive RDT, Pf HRP2 Quansys Q-plex ELISA, and PCR
- Distribution of parasitemia, HRP2, and LDH in an elimination setting
- Measure sensitivity, specificity, NPV, PPV against RDT, PCR, and Q-plex ELISA
- HRP2 and LDH persistence at 0, 30, 90 day follow-up of infected individuals
- Presence of hrp2/3 deletion parasites
Zambia is pushing for, and has made great strides towards, the elimination of malaria transmission in Southern Province. Reactive focal test and treat (RFTAT) using rapid diagnostic tests and artemether-lumefantrine (AL) has been key in making this progress. Reactive focal drug administration (RFDA) using dihydroartemisinin-piperaquine (DHAP), may be superior in accelerating clearance of the parasite reservoir in humans due to the provision of enhanced chemoprophylactic protection of at-risk populations against new infections.
The study will be conducted in Southern Province, Zambia in 16 health facility catchment areas (HFCA) in four districts, namely Kalomo, Monze, Mazabuka and Pemba. The population living in these four districts is estimated to be approximately 130,000 living in approximately 33,000 households from 2010 census data.
Outcomes assessed:
- Malaria seropositivity in children under five after two-year intervention within health center catchment areas
- Total and confirmed outpatient malaria case incidence and inpatient malaria case incidence among all ages
- P. falciparum clearance rate among the cohort of individuals enrolled in a longitudinal study, defined as the percentage of individuals with a P. falciparum infection (based on polymerase chain reaction) enrolled on day 30
- P. falciparum reinfection rate among a cohort of individuals enrolled in a longitudinal study, defined as the percentage of individuals with a P. falciparum infection (based on PCR) enrolled on day 90
- Complexity of infection found during reactive responses to incident malaria infections
- Complexity of infection in endline survey
ClinicalTrials.gov Identifier: NCT02654912
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 4800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
Mar 2016 — Dec 2019
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