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Completed

NCT Number: NCT03576313

Mass Drug Administration of Ivermectin and Dihydroartemisinin-piperaquine as an Additional Intervention for Malaria Elimination

This is a community-based cluster-randomized trial in which a novel approach to interrupt residual malaria transmission by mass drug administration (MDA) with ivermectin (IVM) combined with dihydroartemisinin-piperaquine (DP) will be tested. This cluster-randomized trial will involve 32 villages in the Upper River Region of The Gambia that will be randomized to MDA with IVM and DP or to standard of care in a ratio 1:1. This trial aims at establishing whether MDA with IVM and DP can reduce or interrupt malaria transmission in medium to low transmission settings by reducing vector survival and the human reservoir of infection. MDA with IVM and DP will be implemented in the intervention villages and all human settlements in the buffer zone, with the aim of minimizing spillover effects. Control clusters will receive standard malaria control interventions as implemented by the National Malaria Control Program. The primary outcomes will be the prevalence of malaria infection determined by molecular methods in all age groups at the peak of the second transmission season (November-December 2019) and the vector's parous rate 7-14 days after MDA.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Basse Villages

Basse Santa Su, The Gambia

About this study

The hypothesis of this project is that mass drug administration (MDA) with ivermectin (IVM) and dihydroartemisinin-piperaquine (DP) can reduce or interrupt malaria transmission in medium to low transmission settings by reducing vector survival and the human reservoir of infection. The research questions include the following:

  • Will MDA with IVM plus DP (3 rounds per transmission season) in communities with high coverage of vector control interventions further reduce malaria transmission (up to local elimination)?
  • Will MDA with IVM suppress the vector population?
  • What is the most socially acceptable and sustainable way of achieving and maintaining high coverage of MDA with IVM and DP, and of embedding it within local communities and stakeholders?
  • What is the impact of MDA with IVM on prevalence of ectoparasites and helminths
  • What is the cost and cost-effectiveness of this intervention compared to standard malaria control measures?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age/anthropometry
  • For IVM: weight ≥ 15kg or height ≥90 cm;
  • For DP: age > 6 months
  • Willingness to comply with trial procedures
  • Individual written informed consent obtained at the beginning of the study

Exclusion criteria

  • Exclusion criteria for both IVM and DP will include the following:
  • Known chronic illness (eg HIV, TB, hepatitis and severe malnutrition).

Additionally for IVM:

  • Pregnancy (any trimester) and breast feeding
  • Hypersensitivity to IVM
  • Travel to Loa loa endemic countries (e.g. Central Africa)

Additionally for DP:

  • First trimester pregnancy
  • Hypersensitivity to DP
  • Taking drugs that influence cardiac function or prolong QTc interval

Treatment and study plan

Dihydroartemisinin-piperaquine (DP)

Drug

DP will be available as tablets of 320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet. Administration of a full course of DP will be done as per manufacturer's guidelines once daily for 3 days and according to body weight. DP will be taken orally with water and without food

ivermectin (IVM)

Drug

IVM will be available as tablets of 3mg or 6mg strength. It will be given at 300-400μg/kg/day over 3 days (to the nearest whole tablet). IVM will also be taken on an empty stomach with water

standard malaria control interventions only

Other

this is the standard malaria control interventions in the Gambia

Primary outcomes

  1. prevalence of malaria infection

    Time frame: at 12 months

    Prevalence of malaria infection determined by molecular methods number of participants with a positive varATS quantitative PCR divided by the total number of participants sampled

  2. Vector's parous rate

    Time frame: 7-14 days after mass drug administration (MDA)

    Malaria prevalence will be used as an indicator of on-going malaria transmission, while vector's parous rate will quantify the effect of IVM on vector survival and mosquito population age structure. Proportion: number of parous vectors divided by the total number of collected vectors

Secondary outcomes

  1. malaria prevalence

    Time frame: at 6 months

    malaria prevalence at the peak of the first transmission season of number of participants with a positive varATS quantitative PCR divided by the total number of participants sampled

  2. incidence of clinical (laboratory confirmed) malaria cases

    Time frame: after MDA over 6 months period

    incidence of clinical (laboratory confirmed) malaria cases at health facilities of Number of clinical malaria cases observed divided by person-years of follow-up

  3. serological markers of recent malaria

    Time frame: after MDA over 6 months period

    serological markers of recent malaria infection by Mean Fluorescent Intensity of the different antigens will be determined and presented as a geometric mean

  4. serological markers of recent Anopheles exposure

    Time frame: after MDA over 6 months period

    serological markers of recent Anopheles exposure by Mean Fluorescent Intensity of the different antigens will be determined and presented as a geometric mean

  5. mosquito density

    Time frame: over 24 months after MDA

    Total number of mosquitoes collected during the study period across both intervention and control villages

  6. mosquito mortality

    Time frame: 21 days post treatment

    mosquito mortality after feeding on IVM treated individuals Number of mosquitoes that die after a blood meal 21 days post-treatment divided by total number of mosquitoes blood fed

  7. sporozoite rates in field-caught mosquitoes

    Time frame: over 24 months after MDA

    Number of P. falciparum circumsporozoite antibody (CSP) positive mosquitoes divided by the total number of mosquitoes caught

Other outcomes

  1. drug resistance markers

    Time frame: after MDA 6 months

    prevalence of drug resistance markers in the number of malaria parasites with drug-resistance markers divided by the total number of samples tested

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Imperial College London
  • Institute of Tropical Medicine, Belgium
  • Liverpool School of Tropical Medicine
  • National Malaria Control Programme, The Gambia
  • Radboud University Medical Center
  • University of Durham

Registry information

Acronym: MASSIV

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jul 3, 2018
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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