Study protocol for a cluster randomised controlled factorial design trial to assess the effectiveness and feasibility of reactive focal mass drug administration and vector control to reduce malaria transmission in the low endemic setting of Namibia

Oliver F. Medzihradsky, Immo Kleinschmidt, Davis Mumbengegwi, Kathryn W. Roberts, Patrick McCreesh, Mi Suk Kang Dufour, Petrina Uusiku, Stark Katokele, Adam Bennett, Jennifer Smith, Hugh Sturrock, Lisa M. Prach, Henry Ntuku, Munyaradzi Tambo, Bradley Didier, Bryan Greenhouse, Zaahira Gani, Ann Aerts, Roly Gosling, Michelle S. Hsiang

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

INTRODUCTION: To interrupt malaria transmission, strategies must target the parasite reservoir in both humans and mosquitos. Testing of community members linked to an index case, termed reactive case detection (RACD), is commonly implemented in low transmission areas, though its impact may be limited by the sensitivity of current diagnostics. Indoor residual spraying (IRS) before malaria season is a cornerstone of vector control efforts. Despite their implementation in Namibia, a country approaching elimination, these methods have been met with recent plateaus in transmission reduction. This study evaluates the effectiveness and feasibility of two new targeted strategies, reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) in Namibia.

METHODS AND ANALYSIS: This is an open-label cluster randomised controlled trial with 2×2 factorial design. The interventions include: rfMDA (presumptive treatment with artemether-lumefantrine (AL)) versus RACD (rapid diagnostic testing and treatment using AL) and RAVC (IRS with Acellic 300CS) versus no RAVC. Factorial design also enables comparison of the combined rfMDA+RAVC intervention to RACD. Participants living in 56 enumeration areas will be randomised to one of four arms: rfMDA, rfMDA+RAVC, RACD or RACD+RAVC. These interventions, triggered by index cases detected at health facilities, will be targeted to individuals residing within 500 m of an index. The primary outcome is cumulative incidence of locally acquired malaria detected at health facilities over 1 year. Secondary outcomes include seroprevalence, infection prevalence, intervention coverage, safety, acceptability, adherence, cost and cost-effectiveness.

ETHICS AND DISSEMINATION: Findings will be reported on clinicaltrials.gov, in peer-reviewed publications and through stakeholder meetings with MoHSS and community leaders in Namibia.

TRIAL REGISTRATION NUMBER: NCT02610400; Pre-results.

Original languageEnglish (US)
Pages (from-to)e019294
JournalBMJ Open
Volume8
Issue number1
DOIs
StatePublished - Jan 27 2018

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Namibia
Malaria
Pharmaceutical Preparations
Health Facilities
Seroepidemiologic Studies
Culicidae
Cost-Benefit Analysis
Publications
Parasites
Randomized Controlled Trials
Safety
Costs and Cost Analysis
Incidence
Infection

Keywords

  • Plasmodium falciparum
  • artemether-lumefantrine
  • cluster randomisation
  • elimination
  • indoor residual spraying
  • low transmission
  • malaria
  • mass drug administration
  • Namibia
  • pirimiphos-methyl
  • presumptive treatment
  • reactive case detection
  • vector control

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Study protocol for a cluster randomised controlled factorial design trial to assess the effectiveness and feasibility of reactive focal mass drug administration and vector control to reduce malaria transmission in the low endemic setting of Namibia. / Medzihradsky, Oliver F.; Kleinschmidt, Immo; Mumbengegwi, Davis; Roberts, Kathryn W.; McCreesh, Patrick; Dufour, Mi Suk Kang; Uusiku, Petrina; Katokele, Stark; Bennett, Adam; Smith, Jennifer; Sturrock, Hugh; Prach, Lisa M.; Ntuku, Henry; Tambo, Munyaradzi; Didier, Bradley; Greenhouse, Bryan; Gani, Zaahira; Aerts, Ann; Gosling, Roly; Hsiang, Michelle S.

In: BMJ Open, Vol. 8, No. 1, 27.01.2018, p. e019294.

Research output: Contribution to journalArticle

Medzihradsky, OF, Kleinschmidt, I, Mumbengegwi, D, Roberts, KW, McCreesh, P, Dufour, MSK, Uusiku, P, Katokele, S, Bennett, A, Smith, J, Sturrock, H, Prach, LM, Ntuku, H, Tambo, M, Didier, B, Greenhouse, B, Gani, Z, Aerts, A, Gosling, R & Hsiang, MS 2018, 'Study protocol for a cluster randomised controlled factorial design trial to assess the effectiveness and feasibility of reactive focal mass drug administration and vector control to reduce malaria transmission in the low endemic setting of Namibia', BMJ Open, vol. 8, no. 1, pp. e019294. https://doi.org/10.1136/bmjopen-2017-019294
Medzihradsky, Oliver F. ; Kleinschmidt, Immo ; Mumbengegwi, Davis ; Roberts, Kathryn W. ; McCreesh, Patrick ; Dufour, Mi Suk Kang ; Uusiku, Petrina ; Katokele, Stark ; Bennett, Adam ; Smith, Jennifer ; Sturrock, Hugh ; Prach, Lisa M. ; Ntuku, Henry ; Tambo, Munyaradzi ; Didier, Bradley ; Greenhouse, Bryan ; Gani, Zaahira ; Aerts, Ann ; Gosling, Roly ; Hsiang, Michelle S. / Study protocol for a cluster randomised controlled factorial design trial to assess the effectiveness and feasibility of reactive focal mass drug administration and vector control to reduce malaria transmission in the low endemic setting of Namibia. In: BMJ Open. 2018 ; Vol. 8, No. 1. pp. e019294.
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T1 - Study protocol for a cluster randomised controlled factorial design trial to assess the effectiveness and feasibility of reactive focal mass drug administration and vector control to reduce malaria transmission in the low endemic setting of Namibia

AU - Medzihradsky, Oliver F.

AU - Kleinschmidt, Immo

AU - Mumbengegwi, Davis

AU - Roberts, Kathryn W.

AU - McCreesh, Patrick

AU - Dufour, Mi Suk Kang

AU - Uusiku, Petrina

AU - Katokele, Stark

AU - Bennett, Adam

AU - Smith, Jennifer

AU - Sturrock, Hugh

AU - Prach, Lisa M.

AU - Ntuku, Henry

AU - Tambo, Munyaradzi

AU - Didier, Bradley

AU - Greenhouse, Bryan

AU - Gani, Zaahira

AU - Aerts, Ann

AU - Gosling, Roly

AU - Hsiang, Michelle S.

PY - 2018/1/27

Y1 - 2018/1/27

N2 - INTRODUCTION: To interrupt malaria transmission, strategies must target the parasite reservoir in both humans and mosquitos. Testing of community members linked to an index case, termed reactive case detection (RACD), is commonly implemented in low transmission areas, though its impact may be limited by the sensitivity of current diagnostics. Indoor residual spraying (IRS) before malaria season is a cornerstone of vector control efforts. Despite their implementation in Namibia, a country approaching elimination, these methods have been met with recent plateaus in transmission reduction. This study evaluates the effectiveness and feasibility of two new targeted strategies, reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) in Namibia.METHODS AND ANALYSIS: This is an open-label cluster randomised controlled trial with 2×2 factorial design. The interventions include: rfMDA (presumptive treatment with artemether-lumefantrine (AL)) versus RACD (rapid diagnostic testing and treatment using AL) and RAVC (IRS with Acellic 300CS) versus no RAVC. Factorial design also enables comparison of the combined rfMDA+RAVC intervention to RACD. Participants living in 56 enumeration areas will be randomised to one of four arms: rfMDA, rfMDA+RAVC, RACD or RACD+RAVC. These interventions, triggered by index cases detected at health facilities, will be targeted to individuals residing within 500 m of an index. The primary outcome is cumulative incidence of locally acquired malaria detected at health facilities over 1 year. Secondary outcomes include seroprevalence, infection prevalence, intervention coverage, safety, acceptability, adherence, cost and cost-effectiveness.ETHICS AND DISSEMINATION: Findings will be reported on clinicaltrials.gov, in peer-reviewed publications and through stakeholder meetings with MoHSS and community leaders in Namibia.TRIAL REGISTRATION NUMBER: NCT02610400; Pre-results.

AB - INTRODUCTION: To interrupt malaria transmission, strategies must target the parasite reservoir in both humans and mosquitos. Testing of community members linked to an index case, termed reactive case detection (RACD), is commonly implemented in low transmission areas, though its impact may be limited by the sensitivity of current diagnostics. Indoor residual spraying (IRS) before malaria season is a cornerstone of vector control efforts. Despite their implementation in Namibia, a country approaching elimination, these methods have been met with recent plateaus in transmission reduction. This study evaluates the effectiveness and feasibility of two new targeted strategies, reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) in Namibia.METHODS AND ANALYSIS: This is an open-label cluster randomised controlled trial with 2×2 factorial design. The interventions include: rfMDA (presumptive treatment with artemether-lumefantrine (AL)) versus RACD (rapid diagnostic testing and treatment using AL) and RAVC (IRS with Acellic 300CS) versus no RAVC. Factorial design also enables comparison of the combined rfMDA+RAVC intervention to RACD. Participants living in 56 enumeration areas will be randomised to one of four arms: rfMDA, rfMDA+RAVC, RACD or RACD+RAVC. These interventions, triggered by index cases detected at health facilities, will be targeted to individuals residing within 500 m of an index. The primary outcome is cumulative incidence of locally acquired malaria detected at health facilities over 1 year. Secondary outcomes include seroprevalence, infection prevalence, intervention coverage, safety, acceptability, adherence, cost and cost-effectiveness.ETHICS AND DISSEMINATION: Findings will be reported on clinicaltrials.gov, in peer-reviewed publications and through stakeholder meetings with MoHSS and community leaders in Namibia.TRIAL REGISTRATION NUMBER: NCT02610400; Pre-results.

KW - Plasmodium falciparum

KW - artemether-lumefantrine

KW - cluster randomisation

KW - elimination

KW - indoor residual spraying

KW - low transmission

KW - malaria

KW - mass drug administration

KW - Namibia

KW - pirimiphos-methyl

KW - presumptive treatment

KW - reactive case detection

KW - vector control

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