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

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 3

Conditions: Malaria

Treatments: Other: standard malaria control interventions only; Drug: ivermectin (IVM); Drug: dihydroartemisinin-piperaquine (DP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03576313

SCC 1593

Details and patient eligibility

About

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.

Full 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?

Enrollment: 4,939 patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age/anthropometry

  1. For IVM: weight ≥ 15kg or height ≥90 cm;
  2. 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:

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

Additionally for DP:

1. First trimester pregnancy
2. Hypersensitivity to DP
3. Taking drugs that influence cardiac function or prolong QTc interval

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,939 participants in 2 patient groups

intervention: IVM and DP

Experimental group

Description:

Mass 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

Treatment:

Drug: ivermectin (IVM)

Other: standard malaria control interventions only

Drug: dihydroartemisinin-piperaquine (DP)

control: standard malaria control intervetions

Active Comparator group

Description:

Participants 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

Treatment:

Other: standard malaria control interventions only