Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute of Tropical Medicine, Belgium | OTHER |
| National Malaria Control Programme, The Gambia | OTHER_GOV |
| Liverpool School of Tropical Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention: IVM and DP | Experimental | 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 |
|
| control: standard malaria control intervetions | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 12 months |
| 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 | 7-14 days after mass drug administration (MDA) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 6 months |
| incidence of clinical (laboratory confirmed) malaria cases |
| Measure | Description | Time Frame |
|---|---|---|
| drug resistance markers | prevalence of drug resistance markers in the number of malaria parasites with drug-resistance markers divided by the total number of samples tested | after MDA 6 months |
Inclusion Criteria
Age/anthropometry
Willingness to comply with trial procedures
Individual written informed consent obtained at the beginning of the study
Exclusion Criteria:
Additionally for IVM:
Additionally for DP:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Umberto D'alessandro, MD, PhD | MRC @ LSHTM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basse Villages | Basse Santa Su | The Gambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38383367 | Derived | 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. | |
| 36183416 | Derived |
Not provided
Not provided
Not provided
| Radboud University Medical Center |
| OTHER |
| University of Durham | OTHER |
| Imperial College London | OTHER |
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
Not provided
Not provided
Malaria prevalence will be determined by technicians blinded to the treatment arm
|
| 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 only | Other | this is the standard malaria control interventions in the Gambia |
|
incidence of clinical (laboratory confirmed) malaria cases at health facilities of Number of clinical malaria cases observed divided by person-years of follow-up |
| after MDA over 6 months period |
| 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 | after MDA over 6 months period |
| 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 | after MDA over 6 months period |
| mosquito density | Total number of mosquitoes collected during the study period across both intervention and control villages | over 24 months after MDA |
| 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 | 21 days post treatment |
| sporozoite rates in field-caught mosquitoes | Number of P. falciparum circumsporozoite antibody (CSP) positive mosquitoes divided by the total number of mosquitoes caught | over 24 months after MDA |
| 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. |
| 34919831 | Derived | 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. |
| 33211022 | Derived | 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. |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided