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MalariaPhase 3MASSIVNCT03576313

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

A Phase 3 study testing dihydroartemisinin-piperaquine (DP) and ivermectin (IVM) in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
dihydroartemisinin-piperaquine (DP) and ivermectin (IVM)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,939 participants
Where
1 siteThe Gambia
Study dates
11 Aug 2018to 31 Jul 2021
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 6 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • Additionally for DP:
  • First trimester pregnancy
  • Hypersensitivity to DP
  • Taking drugs that influence cardiac function or prolong QTc interval

Trial locations and contacts

1 site in 1 country.

The Gambia1 site

  • Basse Villages

    Basse Santa Su

Other trials in The Gambia

About this study

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.

Read the detailed description

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:

  1. 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)?
  2. Will MDA with IVM suppress the vector population?
  3. 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?
  4. What is the impact of MDA with IVM on prevalence of ectoparasites and helminths
  5. What is the cost and cost-effectiveness of this intervention compared to standard malaria control measures?
Conditions
Malaria
Being tested
dihydroartemisinin-piperaquine (DP), ivermectin (IVM), standard malaria control interventions only
Keywords
transmission, reduction
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 (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 onlyOther

    this is the standard malaria control interventions in the Gambia

Study groups in NCT03576313
Study groupRoleWhat they receive
intervention: IVM and DPExperimentalMass Drug Administration with ivermectin (IVM) and dihydroartemisinin-piperaquine (DP) will be given to participants in the intervention villages plus the NMCP standard malaria control intervention
Receives: Drug: dihydroartemisinin-piperaquine (DP); Drug: ivermectin (IVM); Other: standard malaria control interventions only
control: standard malaria control intervetionsActive comparatorParticipants in the control clusters will receive only standard malaria control interventions such as Artemether Lumefantrine, LLINs, IRS, SMC and IPTp as implemented by the National Malaria Control Program (NMCP) of the Gambia
Receives: Other: standard malaria control interventions only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prevalence of malaria infection

    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

    Measured: at 12 months

  2. Vector's parous rate

    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

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

Secondary outcomes (7)

  1. malaria prevalence

    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

    Measured: at 6 months

  2. incidence of clinical (laboratory confirmed) malaria cases

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

    Measured: after MDA over 6 months period

  3. serological markers of recent malaria

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

    Measured: after MDA over 6 months period

  4. serological markers of recent Anopheles exposure

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

    Measured: after MDA over 6 months period

  5. mosquito density

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

    Measured: over 24 months after MDA

  6. mosquito mortality

    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

    Measured: 21 days post treatment

  7. sporozoite rates in field-caught mosquitoes

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

    Measured: over 24 months after MDA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2018
  2. Study start11 Aug 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Jul 2021

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,939 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03576313
Sponsor's protocol ID
SCC 1593
Acronym
MASSIV
Status last verified
Mar 2022
First submitted
31 May 2018
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kositz C, Vasileva H, Mohammed N, Achan J, Dabira ED, D'Alessandro U, Bradley J, Marks M. Risk factors for non-participation in ivermectin and dihydroartemisinin-piperaquine mass drug administration for malaria control in the MASSIV trial. Malar J. 2024 Feb 22;23(1):54. doi: 10.1186/s12936-024-04878-2.

    PubMed 38383367

  • Fehr A, Nieto-Sanchez C, Muela J, Manneh E, Baldeh D, Ceesay O, D'Alessandro U, Dabira E, Kingori P, Peeters Grietens K, Bardaji A, Bunders-Aelen J, Zuiderent-Jerak T. Doing 'reciprocity work': The role of fieldworkers in a mass drug administration trial in the Gambia. Glob Public Health. 2022 Dec;17(12):4116-4128. doi: 10.1080/17441692.2022.2125998. Epub 2022 Oct 2.

    PubMed 36183416

  • Dabira ED, Soumare HM, Conteh B, Ceesay F, Ndiath MO, Bradley J, Mohammed N, Kandeh B, Smit MR, Slater H, Peeters Grietens K, Broekhuizen H, Bousema T, Drakeley C, Lindsay SW, Achan J, D'Alessandro U. Mass drug administration of ivermectin and dihydroartemisinin-piperaquine against malaria in settings with high coverage of standard control interventions: a cluster-randomised controlled trial in The Gambia. Lancet Infect Dis. 2022 Apr;22(4):519-528. doi: 10.1016/S1473-3099(21)00557-0. Epub 2021 Dec 15.

    PubMed 34919831

  • Dabira ED, Soumare HM, Lindsay SW, Conteh B, Ceesay F, Bradley J, Kositz C, Broekhuizen H, Kandeh B, Fehr AE, Nieto-Sanchez C, Ribera JM, Peeters Grietens K, Smit MR, Drakeley C, Bousema T, Achan J, D'Alessandro U. Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial. JMIR Res Protoc. 2020 Nov 19;9(11):e20904. doi: 10.2196/20904.

    PubMed 33211022

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dihydroartemisinin-piperaquine (DP) and ivermectin (IVM) in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2022. 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 The Gambia. 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?

prevalence of malaria infection (time frame: at 12 months). The study lists 2 primary outcomes in all. 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 NCT03576313, which also lists 4 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 14 Mar 2022.

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