MalariaPhase 3fMDANCT02315690
Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland
A Phase 3 study testing dihydroartemisinin-piperaquine (DHAp) and reactive case detection in people with Malaria, run by University of California, San Francisco at 1 site in Eswatini.
Trial summary
This is a cluster randomised controlled trial comparing the impact of two community based malaria interventions: reactive case detection (RACD) vs reactive targeted presumptive treatment (focal mass drug administration, fMDA) on the incidence of malaria in Swaziland. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- dihydroartemisinin-piperaquine (DHAp) and reactive case detection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteEswatini
- Study dates
- Sep 2015to Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
RACD Inclusion Criteria:
- Index case resides in study locality
- All non-index cases that reside or spent at least one night in the Target Area in the past 5 weeks
- Non-index case resides within 200 meters of index case unless study team was not able to recruit 30 individuals by 3rd visit, in which case non-index case individuals may reside up to 500 meters from index case
- Provide informed consent
RACD Exclusion Criteria:
- Refusal to participate
- Target Area overlaps with prior RACD Target Area from within the past 5 weeks fMDA Inclusion Criteria:
- Index case resides in study locality
- All non-index cases that reside or have spent at least one night in the Target Area in the past 5 weeks
- Non-index case resides within 200 meters of index case unless study team was not able to recruit 30 individuals by 3rd visit, in which case non-index case individuals may reside up to 500 meters from index case
- Provide informed consent fMDA Exclusion Criteria:
- Refusal to participate
- Temperature > 38.0⁰C, report of fever in the past 48 hours, or other illness (will be referred to the nearest health facility for further evaluation)
- fMDA Target Area overlaps with prior Target Area within the past 8 weeks
- For fMDA specifically (though still eligible for follow-up blood survey):
- Pregnancy, breastfeeding, and women who have had menarche but no menses in the past 4 weeks
- Children less than 6 months of age or <5 kg
- Known allergy or history of adverse reaction to DP (still eligible for f/u blood surveys)
- Already taken 2 courses of DP in the past year or taken 1 course within the past 2 months
- Moderate or severe renal or hepatic insufficiency
- Currently with severe malaria
- Family history of sudden death or of congenital prolongation of the QTc (correct QT interval) interval.
- Known congenital prolongation of the QTc-interval or any clinical condition known to prolong the QTc interval.
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia. Any predisposing cardiac conditions for arrhythmia such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy) or congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
- Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia (including vomiting in child)
- Taking medicinal products that are known to prolong the QTc interval. See note for list of drugs.
- Recent treatment with medicinal products known to prolong the QTc interval that may still be circulating at the time that Eurartesim is commenced (e.g. mefloquine, halofantrine, lumefantrine, chloroquine, quinine and other antimalarial agents) taking into account their elimination half-life
NOTE: Medicinal products that are known to prolong the QTc interval include:
- Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
- Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.
- Certain antimicrobial agents, including agents of the following classes: - macrolides (e.g. erythromycin, clarithromycin), - fluoroquinolones (e.g. moxifloxacin, sparfloxacin), - imidazole and triazole antifungal agents, - and also pentamidine and saquinavir.
- Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine).
- Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide
Trial locations and contacts
1 site in 1 country.
About this study
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
This is a cluster randomised controlled trial comparing the impact of two community based malaria interventions: reactive case detection (RACD) vs reactive targeted presumptive treatment (focal mass drug administration, fMDA) on the incidence of malaria in Swaziland.
Read the detailed description
Title Evaluating the effectiveness and feasibility of reactive focal mass drug administration (fMDA) vs. reactive case detection (RACD) as a community level intervention in response to a passively identified index malaria case in Swaziland
Study design Cluster randomised controlled trial
Aims
Primary aim: To compare the impact of fMDA versus RACD on malaria incidence.
Secondary aims
Effectiveness:
- To compare the impact of fMDA versus RACD on seroprevalence.
- To compare the impact of fMDA versus RACD on prevalence of infection.
Feasibility:
- To evaluate the safety of fMDA.
- To measure the adherence of DHAp using a modified DOT regimen.
- To determine the feasibility of reaching 80% coverage for fMDA.
- To compare the acceptability of fMDA.
- To compare the costs and cost-effectiveness of fMDA versus RACD.
Study site Eastern endemic region of Swaziland, a very low endemic malaria elimination setting. A total of 287 health facilities and their catchment areas are located in this area.
Time frame September 2015 - August 2017
Cluster or unit of randomisation At-risk localities will be randomized to either fMDA or RACD using a block stratified randomization based on risk rank and population
Target area Individuals residing within 200 m (fMDA arm) or 500 m (RACD arm) of an index case detected in passive surveillance, individuals residing immediately beyond 200 m in the fMDA arm will be included if a minimum of 30 individuals are not enrolled within 200 m.
Intervention All individuals residing in study localities will receive vector control preventative measures as per program. 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). Individuals in RACD target areas will be tested by RDT and taken to the nearest health facility for treatment as per program operating procedures.
Evaluation methods The primary outcome measure of incidence will be obtained through routine surveillance data.
Secondary outcomes of effectiveness will be measured at study conclusion by collecting a dried blood spot (DBS) from all residents in target areas in both arms. Prevalence of infection will be measured by loop-mediated isothermal amplification (LAMP) and seroprevalence measured by quantifying markers of recent malaria exposure.
Secondary outcomes of feasibility will be measured as follows:
- Safety: number of serious adverse events deemed possibly, probably, or definitely related to DHAp.
- Adherence: proportion of individuals who completed three days of therapy among all individuals initiated on DHAp in the fMDA arm, assessed by pill count.
- Coverage: proportion of individuals residing within 200m (fMDA localities) or 500m (RACD localities) of an index case who consented to participate and who completed the initial procedures for their study arm (initial dose of DHAp in the fMDA arm or finger prick for RDT in the RACD arm).
- Acceptability: proportion of eligible individuals refusing to take part in the study and a qualitative assessment of a subset of individuals in the fMDA arm.
- Cost: cost per index case-level intervention and cost per case averted.
Sample size The sample size is based on the number of study localities that experienced at least one incident case of malaria in the previous season. Within 77 randomized localities, we expect that 63 localities will have an incident case of malaria and receive an intervention. For the primary objective, we hypothesize that mFDA will be more effective than RACD. At the current sample size, the study is powered to detect a difference in cumulative incidence if incidence in the fMDA arm is reduced 50% compared to the RACD arm. Incidence will be measured at the locality level and among the at-risk population, or all individuals in an enumeration area (EA) where at least one case was identified (expected to be approximately 55,928 individuals among a total study population of 211,189, or a harmonic mean of 656 per locality (41,328 effective population)). Secondary outcomes of seroprevalence and prevalence will be measured on individuals residing in target areas (total N=5,400) with a harmonic mean of 60 persons receiving intervention per locality (3,780 effective population).
Primary outcome Incidence of malaria cases
Secondary outcomes
- Seroprevalence by ELISA
- Prevalence of infection
- Coverage of the intervention: proportion of the target population that receives a finger prick in the RACD arm and receives an initial dose of DHAp in the TPE arm (intention to treat analysis).
- Adherence to DHAp in TPE arm.
- Safety of DHAp
- Acceptance
- Cost per intervention episode, per case averted
- Conditions
- Malaria
- Being tested
- dihydroartemisinin-piperaquine (DHAp), reactive case detection
- Keywords
- malaria, Swaziland, reactive case detection, focal mass drug administration
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dihydroartemisinin-piperaquine (DHAp)Drug
Also called Eurartesim
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).
reactive case detectionProcedure or surgery
Also called screen and treat; test and treat
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.
| Study group | Role | What they receive |
|---|---|---|
| Reactive case detection (RACD) | Active comparator | 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. Receives: Procedure: reactive case detection |
| Reactive focal mass drug administration (fMDA) | Experimental | 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). Receives: Drug: dihydroartemisinin-piperaquine (DHAp) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malaria cases
Cumulative incidence of malaria cases by locality
Measured: 2 years
Secondary outcomes (7)
Seroprevalence
Prevalence of antibody response to markers of recent malaria exposure in target areas
Measured: during end line survey after intervention data collection completed
Prevalence
Prevalence of infection by loop mediated isothermal amplification (LAMP) in target areas
Measured: during end line survey after intervention data collection completed
Coverage
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)
Measured: 2 years
Adherence
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
Measured: 2 years
Safety related to DHAp
Number of participants experiencing serious adverse events (SAEs) deemed possibly, probably, or definitely related to DHAp
Measured: 2 years
Acceptability
Qualitative assessment among individuals residing in target areas and with surveillance agents.
Measured: 2 years
Cost
Cost per index case-level intervention, cost per case averted, collected in 10 RACD and 10 fMDA events.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startSep 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Swaziland, Clinton Health Access Initiative, Eswatini, University of Texas
- Responsible party
- Sponsor
- Investigators
- Michelle S Hsiang, MD, Principal investigator, UTSW, UCSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315690
- Sponsor's protocol ID
- Swaziland fMDA
- Acronym
- fMDA
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2014
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsiang MS, Hwang J, Kunene S, Drakeley C, Kandula D, Novotny J, Parizo J, Jensen T, Tong M, Kemere J, Dlamini S, Moonen B, Angov E, Dutta S, Ockenhouse C, Dorsey G, Greenhouse B. Surveillance for malaria elimination in Swaziland: a national cross-sectional study using pooled PCR and serology. PLoS One. 2012;7(1):e29550. doi: 10.1371/journal.pone.0029550. Epub 2012 Jan 6.
PubMed 22238621Sturrock HJ, Novotny JM, Kunene S, Dlamini S, Zulu Z, Cohen JM, Hsiang MS, Greenhouse B, Gosling RD. Reactive case detection for malaria elimination: real-life experience from an ongoing program in Swaziland. PLoS One. 2013 May 20;8(5):e63830. doi: 10.1371/journal.pone.0063830. Print 2013.
PubMed 23700437Zani B, Gathu M, Donegan S, Olliaro PL, Sinclair D. Dihydroartemisinin-piperaquine for treating uncomplicated Plasmodium falciparum malaria. Cochrane Database Syst Rev. 2014 Jan 20;2014(1):CD010927. doi: 10.1002/14651858.CD010927.
PubMed 24443033Lwin KM, Phyo AP, Tarning J, Hanpithakpong W, Ashley EA, Lee SJ, Cheah P, Singhasivanon P, White NJ, Lindegardh N, Nosten F. Randomized, double-blind, placebo-controlled trial of monthly versus bimonthly dihydroartemisinin-piperaquine chemoprevention in adults at high risk of malaria. Antimicrob Agents Chemother. 2012 Mar;56(3):1571-7. doi: 10.1128/AAC.05877-11. Epub 2012 Jan 17.
PubMed 22252804Nankabirwa JI, Wandera B, Amuge P, Kiwanuka N, Dorsey G, Rosenthal PJ, Brooker SJ, Staedke SG, Kamya MR. Impact of intermittent preventive treatment with dihydroartemisinin-piperaquine on malaria in Ugandan schoolchildren: a randomized, placebo-controlled trial. Clin Infect Dis. 2014 May;58(10):1404-12. doi: 10.1093/cid/ciu150. Epub 2014 Mar 12.
PubMed 24621953Hsiang MS, Hwang J, Tao AR, Liu Y, Bennett A, Shanks GD, Cao J, Kachur SP, Feachem RG, Gosling RD, Gao Q. Mass drug administration for the control and elimination of Plasmodium vivax malaria: an ecological study from Jiangsu province, China. Malar J. 2013 Nov 1;12:383. doi: 10.1186/1475-2875-12-383.
PubMed 24175930Vilakati S, Mngadi N, Benjamin-Chung J, Dlamini N, Dufour MK, Whittemore B, Bhangu K, Prach LM, Baltzell K, Nhlabathi N, Malambe C, Dlamini B, Helb D, Greenhouse B, Maphalala G, Pindolia D, Kalungero M, Tesfa G, Gosling R, Ntshalintshali N, Kunene S, Hsiang MS. Effectiveness and safety of reactive focal mass drug administration (rfMDA) using dihydroartemisinin-piperaquine to reduce malaria transmission in the very low-endemic setting of Eswatini: a pragmatic cluster randomised controlled trial. BMJ Glob Health. 2021 Jun;6(6):e005021. doi: 10.1136/bmjgh-2021-005021.
PubMed 34193475
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02315690
- Acronym / sponsor ID
- fMDA / Swaziland fMDA
- Conditions
- Malaria
- Keywords
- malaria, Swaziland, reactive case detection, focal mass drug administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Ministry of Health, Swaziland, Clinton Health Access Initiative, Eswatini, University of Texas
- Study start
- Sep 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cluster randomised controlled trial comparing the impact of two community based malaria interventions: reactive case detection (RACD) vs reactive targeted presumptive treatment (focal mass drug administration, fMDA) on the incidence of malaria in Swaziland.
Detailed description
Title Evaluating the effectiveness and feasibility of reactive focal mass drug administration (fMDA) vs. reactive case detection (RACD) as a community level intervention in response to a passively identified index malaria case in Swaziland
Study design Cluster randomised controlled trial
Aims
Primary aim: To compare the impact of fMDA versus RACD on malaria incidence.
Secondary aims
Effectiveness:
- To compare the impact of fMDA versus RACD on seroprevalence.
- To compare the impact of fMDA versus RACD on prevalence of infection.
Feasibility:
- To evaluate the safety of fMDA.
- To measure the adherence of DHAp using a modified DOT regimen.
- To determine the feasibility of reaching 80% coverage for fMDA.
- To compare the acceptability of fMDA.
- To compare the costs and cost-effectiveness of fMDA versus RACD.
Study site Eastern endemic region of Swaziland, a very low endemic malaria elimination setting. A total of 287 health facilities and their catchment areas are located in this area.
Time frame September 2015 - August 2017
Cluster or unit of randomisation At-risk localities will be randomized to either fMDA or RACD using a block stratified randomization based on risk rank and population
Target area Individuals residing within 200 m (fMDA arm) or 500 m (RACD arm) of an index case detected in passive surveillance, individuals residing immediately beyond 200 m in the fMDA arm will be included if a minimum of 30 individuals are not enrolled within 200 m.
Intervention All individuals residing in study localities will receive vector control preventative measures as per program. 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). Individuals in RACD target areas will be tested by RDT and taken to the nearest health facility for treatment as per program operating procedures.
Evaluation methods The primary outcome measure of incidence will be obtained through routine surveillance data.
Secondary outcomes of effectiveness will be measured at study conclusion by collecting a dried blood spot (DBS) from all residents in target areas in both arms. Prevalence of infection will be measured by loop-mediated isothermal amplification (LAMP) and seroprevalence measured by quantifying markers of recent malaria exposure.
Secondary outcomes of feasibility will be measured as follows:
- Safety: number of serious adverse events deemed possibly, probably, or definitely related to DHAp.
- Adherence: proportion of individuals who completed three days of therapy among all individuals initiated on DHAp in the fMDA arm, assessed by pill count.
- Coverage: proportion of individuals residing within 200m (fMDA localities) or 500m (RACD localities) of an index case who consented to participate and who completed the initial procedures for their study arm (initial dose of DHAp in the fMDA arm or finger prick for RDT in the RACD arm).
- Acceptability: proportion of eligible individuals refusing to take part in the study and a qualitative assessment of a subset of individuals in the fMDA arm.
- Cost: cost per index case-level intervention and cost per case averted.
Sample size The sample size is based on the number of study localities that experienced at least one incident case of malaria in the previous season. Within 77 randomized localities, we expect that 63 localities will have an incident case of malaria and receive an intervention. For the primary objective, we hypothesize that mFDA will be more effective than RACD. At the current sample size, the study is powered to detect a difference in cumulative incidence if incidence in the fMDA arm is reduced 50% compared to the RACD arm. Incidence will be measured at the locality level and among the at-risk population, or all individuals in an enumeration area (EA) where at least one case was identified (expected to be approximately 55,928 individuals among a total study population of 211,189, or a harmonic mean of 656 per locality (41,328 effective population)). Secondary outcomes of seroprevalence and prevalence will be measured on individuals residing in target areas (total N=5,400) with a harmonic mean of 60 persons receiving intervention per locality (3,780 effective population).
Primary outcome Incidence of malaria cases
Secondary outcomes
- Seroprevalence by ELISA
- Prevalence of infection
- Coverage of the intervention: proportion of the target population that receives a finger prick in the RACD arm and receives an initial dose of DHAp in the TPE arm (intention to treat analysis).
- Adherence to DHAp in TPE arm.
- Safety of DHAp
- Acceptance
- Cost per intervention episode, per case averted
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reactive case detection (RACD) | Active comparator | Procedure: reactive case detectionIndividuals 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. |
| Reactive focal mass drug administration (fMDA) | Experimental | 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dihydroartemisinin-piperaquine (DHAp)Also: EurartesimIn 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 | Reactive focal mass drug administration (fMDA) |
| reactive case detectionAlso: screen and treat; test and treatIndividuals 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. | Procedure or surgery | Reactive case detection (RACD) |
Primary outcome
Incidence of malaria cases
Time frame: 2 years
Cumulative incidence of malaria cases by locality
7 secondary outcomes
Seroprevalence
Time frame: during end line survey after intervention data collection completed
Prevalence
Time frame: during end line survey after intervention data collection completed
Coverage
Time frame: 2 years
Adherence
Time frame: 2 years
Safety related to DHAp
Time frame: 2 years
Acceptability
Time frame: 2 years
Cost
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 22238621Hsiang MS, Hwang J, Kunene S, Drakeley C, Kandula D, Novotny J, Parizo J, Jensen T, Tong M, Kemere J, Dlamini S, Moonen B, Angov E, Dutta S, Ockenhouse C, Dorsey G, Greenhouse B. Surveillance for malaria elimination in Swaziland: a national cross-sectional study using pooled PCR and serology. PLoS One. 2012;7(1):e29550. doi: 10.1371/journal.pone.0029550. Epub 2012 Jan 6.
- Background: PubMed 23700437Sturrock HJ, Novotny JM, Kunene S, Dlamini S, Zulu Z, Cohen JM, Hsiang MS, Greenhouse B, Gosling RD. Reactive case detection for malaria elimination: real-life experience from an ongoing program in Swaziland. PLoS One. 2013 May 20;8(5):e63830. doi: 10.1371/journal.pone.0063830. Print 2013.
- Background: PubMed 24443033Zani B, Gathu M, Donegan S, Olliaro PL, Sinclair D. Dihydroartemisinin-piperaquine for treating uncomplicated Plasmodium falciparum malaria. Cochrane Database Syst Rev. 2014 Jan 20;2014(1):CD010927. doi: 10.1002/14651858.CD010927.
- Background: PubMed 22252804Lwin KM, Phyo AP, Tarning J, Hanpithakpong W, Ashley EA, Lee SJ, Cheah P, Singhasivanon P, White NJ, Lindegardh N, Nosten F. Randomized, double-blind, placebo-controlled trial of monthly versus bimonthly dihydroartemisinin-piperaquine chemoprevention in adults at high risk of malaria. Antimicrob Agents Chemother. 2012 Mar;56(3):1571-7. doi: 10.1128/AAC.05877-11. Epub 2012 Jan 17.
- Background: PubMed 24621953Nankabirwa JI, Wandera B, Amuge P, Kiwanuka N, Dorsey G, Rosenthal PJ, Brooker SJ, Staedke SG, Kamya MR. Impact of intermittent preventive treatment with dihydroartemisinin-piperaquine on malaria in Ugandan schoolchildren: a randomized, placebo-controlled trial. Clin Infect Dis. 2014 May;58(10):1404-12. doi: 10.1093/cid/ciu150. Epub 2014 Mar 12.
- Background: PubMed 24175930Hsiang MS, Hwang J, Tao AR, Liu Y, Bennett A, Shanks GD, Cao J, Kachur SP, Feachem RG, Gosling RD, Gao Q. Mass drug administration for the control and elimination of Plasmodium vivax malaria: an ecological study from Jiangsu province, China. Malar J. 2013 Nov 1;12:383. doi: 10.1186/1475-2875-12-383.
- Derived from this study: PubMed 34193475Vilakati S, Mngadi N, Benjamin-Chung J, Dlamini N, Dufour MK, Whittemore B, Bhangu K, Prach LM, Baltzell K, Nhlabathi N, Malambe C, Dlamini B, Helb D, Greenhouse B, Maphalala G, Pindolia D, Kalungero M, Tesfa G, Gosling R, Ntshalintshali N, Kunene S, Hsiang MS. Effectiveness and safety of reactive focal mass drug administration (rfMDA) using dihydroartemisinin-piperaquine to reduce malaria transmission in the very low-endemic setting of Eswatini: a pragmatic cluster randomised controlled trial. BMJ Glob Health. 2021 Jun;6(6):e005021. doi: 10.1136/bmjgh-2021-005021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle S Hsiang, MD principal investigator
UTSW, UCSF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dihydroartemisinin-piperaquine (DHAp) and reactive case detection in people with Malaria, run by University of California, San Francisco at 1 site in Eswatini.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of malaria cases (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02315690, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.