Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland (fMDA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02315690|
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : September 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: dihydroartemisinin-piperaquine (DHAp) Procedure: reactive case detection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Effectiveness and Feasibility of Reactive Focal Mass Drug Administration vs. Reactive Case Detection as a Community Level Intervention in Response to a Passively Identified Index Malaria Case in Swaziland|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Active Comparator: Reactive case detection (RACD)
Individuals in RACD Target Areas will be tested by RDT (rapid diagnostic test) and if positive, taken to the nearest health facility for treatment with artemether-lumefantrine per national policy.
Procedure: reactive case detection
Individuals in RACD target areas will be tested by RDT and if positive will be taken to the nearest health facility for treatment as per program operating procedures.
Other Name: screen and treat; test and treat
Experimental: Reactive focal mass drug administration (fMDA)
In the fMDA arm, all individuals in the Target Area will receive dihydroartemisinin-piperaquine (DHAp) once daily for 3 days with the first dose taken no later than 5 weeks from the index case presentation (goal within one week).
Drug: dihydroartemisinin-piperaquine (DHAp)
In the fMDA arm, all individuals in the target area will receive dihydroartemisinin-piperaquine (DHAp) once daily for 3 days with the first dose taken no later than 5 weeks from the index case presentation (goal within one week).
Other Name: Eurartesim
- Incidence of malaria cases [ Time Frame: 2 years ]Cumulative incidence of malaria cases by locality
- Seroprevalence [ Time Frame: during end line survey after intervention data collection completed ]Prevalence of antibody response to markers of recent malaria exposure in target areas
- Prevalence [ Time Frame: during end line survey after intervention data collection completed ]Prevalence of infection by loop mediated isothermal amplification (LAMP) in target areas
- Coverage [ Time Frame: 2 years ]Proportion of persons residing within approximately 200 m of the index case who consented to participate in the study and who completed the initial procedures for their study arm (finger prick for RDT (rapid diagnostic test) in the RACD arm, initial dose of DHAp in the fMDA arm)
- Adherence [ Time Frame: 2 years ]Proportion of persons who completed 3 days of therapy among all individuals initiated on fMDA as assessed by pill count in the first intervention per study locality
- Safety related to DHAp [ Time Frame: 2 years ]Number of participants experiencing serious adverse events (SAEs) deemed possibly, probably, or definitely related to DHAp
- Acceptability [ Time Frame: 2 years ]Qualitative assessment among individuals residing in target areas and with surveillance agents.
- Cost [ Time Frame: 2 years ]Cost per index case-level intervention, cost per case averted, collected in 10 RACD and 10 fMDA events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315690
|Swaziland Ministry of Health|
|Principal Investigator:||Michelle S Hsiang, MD||UTSW, UCSF|