Malaria Clinical Trial
Official title:
Estimating the Malaria Prevention Impact of New Nets: Observational Analyses to Evaluate the Evidence Generated During Piloted New Net Distributions in Burkina Faso
NCT number | NCT04157894 |
Other study ID # | 1379279-2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 7, 2019 |
Est. completion date | July 6, 2022 |
Verified date | January 2022 |
Source | PATH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The use of insecticide-treated bed nets (ITN) has contributed to the substantial reduction in malaria cases and deaths. This progress is threatened by increasing resistance commonly used insecticides in mosquito populations. Newly developed, next-generation ITNs using two insecticides or an insecticide synergist and an insecticide are effective against resistant mosquitoes, but large-scale uptake of these nets has been slow due to higher costs and lack of enough evidence to support broad policy recommendations. This observational study will occur alongside a pilot distribution of next-generation ITNs and collect data over three years on their entomological and epidemiological impact as well as anthropological factors that influence their uptake and use. Data collection will occur in three districts: one receiving dual-active ingredient ITNs, Interceptor® G2 (BASF), one receiving a standard pyrethroid long-lasting insecticidal net (LLIN), Interceptor® (BASF), and one receiving PermaNet®3.0 (Vestergaard) an LLIN containing an insecticide and an insecticide synergist. Data will be collected on malaria vector bionomics, disease epidemiology, and human behaviors in order to help better demonstrate the public health value of next-generation ITNs and to support donors, policymakers, and National Malaria Control Programs in their ITN decision-making and planning processes.
Status | Completed |
Enrollment | 5606 |
Est. completion date | July 6, 2022 |
Est. primary completion date | July 6, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months and older |
Eligibility | Inclusion Criteria: - Passive data collection: All suspected malaria cases (fevers) that self-present to the national health system and are counted in the district health surveillance systems. - Cross-sectional survey: Households in the district with a family member from the target age group. - Residents of the household visited. - Questionnaire: parent or guardian giving written informed consent (cross-sectional). - Malaria screening: child aged 6 to 59 months from the above consenting household. - Individuals of box sexes, not belonging to vulnerable categories (those with cognitive impairment or other person for whom full and open consent cannot be guaranteed) (Key informant interviews, focus group discussions, and participant observations). - Individuals 20 years old and above (key informant interviews, focus group discussions, participant observations). - Individuals of both sexes regardless of age (structured observations). Exclusion Criteria: - District non-residents. - Malaria screening: history of recent (within one month) malaria infection or treatment with anti-malarial medication (cross-sectional). - Parents or guardians who have not yet reached age of consent (20 years) and their children will not be included in study activities requiring consent. - Individuals belonging to vulnerable categories (key informant interviews, focus group discussions, participant observations). - Individuals unwilling and/or unable of giving consent (key informant interviews, focus group discussions, participant observations). - Individuals below age of consent (20 years) (key informant interviews, focus group discussions, participant observations) - Heads of households unwilling and/or unable of giving consent (structured observations) - Individuals who do not wish to be included in observations will be excluded (structured observations) |
Country | Name | City | State |
---|---|---|---|
Burkina Faso | Centre National de Recherche et de Formation sur le Paludisme | Ouagadougou |
Lead Sponsor | Collaborator |
---|---|
PATH | Centre national de recherche et de formation sur le paludisme, Liverpool School of Tropical Medicine |
Burkina Faso,
Alonso P, Noor AM. The global fight against malaria is at crossroads. Lancet. 2017 Dec 9;390(10112):2532-2534. doi: 10.1016/S0140-6736(17)33080-5. Epub 2017 Nov 29. No abstract available. — View Citation
Badolo A, Traore A, Jones CM, Sanou A, Flood L, Guelbeogo WM, Ranson H, Sagnon N. Three years of insecticide resistance monitoring in Anopheles gambiae in Burkina Faso: resistance on the rise? Malar J. 2012 Jul 16;11:232. doi: 10.1186/1475-2875-11-232. — View Citation
Bass C, Nikou D, Donnelly MJ, Williamson MS, Ranson H, Ball A, Vontas J, Field LM. Detection of knockdown resistance (kdr) mutations in Anopheles gambiae: a comparison of two new high-throughput assays with existing methods. Malar J. 2007 Aug 13;6:111. doi: 10.1186/1475-2875-6-111. — View Citation
Bayili K, N'do S, Namountougou M, Sanou R, Ouattara A, Dabire RK, Ouedraogo AG, Malone D, Diabate A. Evaluation of efficacy of Interceptor(R) G2, a long-lasting insecticide net coated with a mixture of chlorfenapyr and alpha-cypermethrin, against pyrethroid resistant Anopheles gambiae s.l. in Burkina Faso. Malar J. 2017 May 8;16(1):190. doi: 10.1186/s12936-017-1846-4. — View Citation
Bhatt S, Weiss DJ, Cameron E, Bisanzio D, Mappin B, Dalrymple U, Battle K, Moyes CL, Henry A, Eckhoff PA, Wenger EA, Briet O, Penny MA, Smith TA, Bennett A, Yukich J, Eisele TP, Griffin JT, Fergus CA, Lynch M, Lindgren F, Cohen JM, Murray CLJ, Smith DL, Hay SI, Cibulskis RE, Gething PW. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature. 2015 Oct 8;526(7572):207-211. doi: 10.1038/nature15535. Epub 2015 Sep 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative malaria incidence | Malaria incidence measured through passive case detection at health facilities in each district. This measure accounts for symptomatic cases self-reporting to the formal health system for care. | July 2019 to December 2022, monthly | |
Secondary | Vector species composition | All Anopheles mosquitoes sampled during Centers for Disease Control and Prevention light traps (CDCLT) and human landing collections (HLC) will be identified morphologically to species group | July 2019 to December 2022, monthly | |
Secondary | Species-specific population densities | Based on Anopheles mosquitoes sampled during CDCLT | July 2019 to December 2022, monthly | |
Secondary | Biting behaviors | Based on Anopheles mosquitoes sampled during CDCLT | July 2019 to December 2022, monthly | |
Secondary | Estimated entomological inoculation rates | Based on Anopheles mosquitoes sampled during CDCLT and HLC | July 2019 to December 2022, monthly | |
Secondary | Insecticide resistance profile | Measurement of kdr and ace-1 mutation frequencies, WHO tube bioassays at minimum and CDC bottle bioassays to characterize insecticide resistance intensity | July 2019 to December 2022, monthly | |
Secondary | Parasite prevalence in children 6-59 months | Prevalence calculated from cross-sectional surveys conducted during the peak transmission season. | July 2019, July 2020, July 2021, July 2022 |
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