NCT02910934: COST

Cost-effectiveness Evaluation of Vector Control Strategies in Mozambique

Completed NA Last updated 17 September 2020

What this trial tests

NA trial testing Actellic CS in Malaria in 3,915 participants. Completed in 31 December 2019.

Timeline

10 January 2017

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	PATH
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	3,915
Start date	10 January 2017
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	2 locations across Mozambique, United States

Drugs / interventions tested

• Actellic CS

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

PATH — full company profile →

Who can join

6 Months and older, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to provide National Malaria Control Programs (NMCP), international donors and other key stakeholders with clear evidence on the impact and cost-effectiveness of using indoor residual spraying (IRS) with a non-pyrethroid insecticide in a high malaria transmission area that has universal long-lasting insecticidal net (LLIN) coverage. This is an interventional study with IRS serving as the research intervention.

The district of Mopeia, in the province of Zambezia, Mozambique will be the study site. This is a high transmission area with a malaria parasite prevalence of 54% in children. The Ministry of Health distributed LLINs in Mopeia in 2014-2015.

The NMCP through funding from President's Malaria Initiative Africa Indoor Residual Spraying Project (PMI-AIRS) was able to cover half a district with indoor residual spraying. A simplified census took place in mid-2016 to determine the number of children five years of age and under in the district and enumerate and map the households to assist in implementation.

From the 115 villages/bairros existent in Mopeia, 86 clusters were randomized in a government randomization ceremony to either receive IRS with Actellic or maintain no IRS. The IRS was implemented through a partnership between the NMCP and PMI-AIRS according to standard operational and consent procedures. From each cluster, a cohort of 18 children five years of age and under will be followed monthly to assess malaria incidence at the community level in both IRS and non-IRS villages. There will be 774 children in the IRS villages and 774 children in the no-IRS villages (total cohort will be 1548). Additionally, the routine health centre reporting system will be strengthened to assess malaria incidence in children five years of age and under by passive case detection. Three cross sectional studies in April 2017, April 2018, and April 2019 will assess changes in net use, health seeking behaviour and malaria prevalence at the community level.

Entomological data will be collected from both IRS and non-IRS areas to assess the vector dynamics and insecticide resistance pattern of the local vector populations from sprayed and unsprayed areas. Data on the costs of the implementation as well as health-related expenditures at health system and household levels will be collected prospectively throughout the study. These costs will be determined using both health system and societal perspectives.

The incidence rate in IRS and no-IRS areas will be combined with the micro-costing data to calculate the cost per case averted at community and health facility level.

These findings will be disseminated to the NMCP and international donors and stakeholders to complement the World Health Organization (WHO) guidance on combining indoor residual spraying and long-lasting insecticidal nets.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Incremental impact on malaria incidence following indoor residual spraying in a highly endemic area with high standard ITN access in Mozambique: results from a cluster-randomized study.
   Chaccour C, Zulliger R, Wagman J, Casellas A, et al · · 2021 · cited 31× · PMID 33568137 · DOI 10.1186/s12936-021-03611-7
2. Reduced exposure to malaria vectors following indoor residual spraying of pirimiphos-methyl in a high-burden district of rural Mozambique with high ownership of long-lasting insecticidal nets: entomological surveillance results from a cluster-randomized trial.
   Wagman JM, Varela K, Zulliger R, Saifodine A, et al · · 2021 · cited 23× · PMID 33478533 · DOI 10.1186/s12936-021-03583-8
3. Combination of indoor residual spraying with long-lasting insecticide-treated nets for malaria control in Zambezia, Mozambique: a cluster randomised trial and cost-effectiveness study protocol.
   Chaccour CJ, Alonso S, Zulliger R, Wagman J, et al · · 2018 · cited 20× · PMID 29564161 · DOI 10.1136/bmjgh-2017-000610
4. Cost and cost-effectiveness of indoor residual spraying with pirimiphos-methyl in a high malaria transmission district of Mozambique with high access to standard insecticide-treated nets.
   Alonso S, Chaccour CJ, Wagman J, Candrinho B, et al · · 2021 · cited 13× · PMID 33691706 · DOI 10.1186/s12936-021-03687-1