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

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.

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?

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