Mass Drug Administration of Ivermectin and Dihydroartemisinin-piperaquine as an Additional Intervention for Malaria Elimination
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 4,939
- Locations
- 1
- Primary Endpoint
- prevalence of malaria infection
Study Overview
Brief 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. 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.
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:
- 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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Malaria prevalence will be determined by technicians blinded to the treatment arm
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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
Arms & Interventions
intervention: IVM and DP
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
Intervention: dihydroartemisinin-piperaquine (DP) (Drug)
intervention: IVM and DP
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
Intervention: ivermectin (IVM) (Drug)
intervention: IVM and DP
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
Intervention: standard malaria control interventions only (Other)
control: standard malaria control intervetions
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
Intervention: standard malaria control interventions only (Other)
Outcomes
Primary Outcomes
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
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
- malaria prevalence(at 6 months)
- incidence of clinical (laboratory confirmed) malaria cases(after MDA over 6 months period)
- serological markers of recent malaria(after MDA over 6 months period)
- serological markers of recent Anopheles exposure(after MDA over 6 months period)
- mosquito density(over 24 months after MDA)
- mosquito mortality(21 days post treatment)
- sporozoite rates in field-caught mosquitoes(over 24 months after MDA)