Effectiveness of Mass Drug Administration (MDA) for Reducing Seasonal Malaria Transmission Towards Its Elimination in Hotspot Areas in Zanzibar – a Cluster-randomised Controlled Trial (MaDrAZ)

Cluster randomized control trial consisting of 2 rounds of Mass Drug Administration 4 weeks apart. The drugs used are dihydroartemisinin-piperaquine + primaquine (single low dose, 0.25mg/kg) through house-to-house campaigns.

In both arms, there will be the distribution of LLINs, IRS and passive case detection of individuals seeking treatment at local health facilities. 16 hotspot Shehias (8 Shehias randomly allocated to each arm) will be selected in three districts (West, Central and South) in Unguja Island, Zanzibar, with an estimated enrollment of 24000 individuals. 

Outcome measures:

(Primary)

• Cumulative notified malaria incidence in the MDA and control Shehias 6 months after the second round of MDA

(Secondary)

• PCR determined community prevalence of Plasmodium infections in the MDA and control Shehias at baseline and 6 months after the second round of MDA
• Population coverage of the MDA intervention at each round
• Proportion of population receiving two rounds of MDA
• Population compliance to the MDA intervention at each round
• Occurence of adverse events after MDA
• Cumulative notified malaria incidence in the MDA and control Shehias during the following high transmission season 15 months after the second round of MDA

Exclusion criteria: 

• First-trimester pregnancy
• Severe disease
• Concurrent antimalarial treatment at time of MDA or during the last 14 days
• Inability to take oral medication
• Additional exclusion criteria for treatment with Primaquine
  • Pregnancy all trimesters
  • Women breastfeeding infants aged <6 months

Clinicaltrials.gov ID: NCT02721186

Type: Interventional
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Primary purpose: Prevention

MaDrAZ

Drug-based Strategies

Jan 2016 — Dec 2016

Tanzania

Mass Drug Administration (MDA)