Cost-effectiveness Evaluation of Vector Control Strategies in Mozambique

NCT02910934 | Completed

• 1 other identifier: 946238-1 (EOM)
• Study Type: interventional
• Target: 3,915
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Malaria

Keywords

Indoor Residual Spray; IRS; Insecticide Treated Net; LLIN; ITN; Long lasting insecticidal net

Outcome Measures

Primary Outcomes (1)

• Cost per case averted in children five years of age and under at health facility level by adding Actellic-IRS

  Incidence at health facility level by passive case detection (with enhanced surveillance and quality control) along with implementation costing data using an ingredients approach

  24 months

Secondary Outcomes (4)

• Entomological Indicators

  24 months

• Parasite prevalence

  12 months

• Health Behavior

  24 months

• Cost per malaria case averted in children five years of age and under at the community

  24months

Study Arms (2)

IRS

EXPERIMENTAL

This arm is comprised of village clusters that have received indoor residual spray with Actellic CS.

Other: Actellic CS

non-IRS

NO INTERVENTION

This arm is comprised of village clusters that will not receive indoor residual spray

Interventions

Actellic CS OTHER

Indoor residual spray with Actellic CS

IRS

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all consenting adults, assenting minors (12-18) and caregivers of children under 12

You may not qualify if:

• all infants 0-6 months of age

Sponsors & Collaborators

• PATH: lead
• United States Agency for International Development (USAID): collaborator
• Abt Associates: collaborator
• Centers for Disease Control and Prevention: collaborator
• Ministry of Health, Mozambique: collaborator
• Centro de Investigacao em Saude de Manhica: collaborator

Study Sites (2)

Molly Robertson

Washington D.C., District of Columbia, 20010, United States

Location

Centro de Investigacoes de Manhica

Manhiça, Maputo Province, Mozambique

Location

Related Publications (4)

• Alonso S, Chaccour CJ, Wagman J, Candrinho B, Muthoni R, Saifodine A, Saute F, Robertson M, Zulliger R. 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. Malar J. 2021 Mar 10;20(1):143. doi: 10.1186/s12936-021-03687-1.

  PMID: 33691706 DERIVED

• Chaccour C, Zulliger R, Wagman J, Casellas A, Nacima A, Elobolobo E, Savaio B, Saifodine A, Fornadel C, Richardson J, Candrinho B, Robertson M, Saute F. 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. Malar J. 2021 Feb 10;20(1):84. doi: 10.1186/s12936-021-03611-7.

  PMID: 33568137 DERIVED

• Wagman JM, Varela K, Zulliger R, Saifodine A, Muthoni R, Magesa S, Chaccour C, Gogue C, Tynuv K, Seyoum A, Dengela D, Saute F, Richardson JH, Fornadel C, Linton YM, Slutsker L, Candrinho B, Robertson M. 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. Malar J. 2021 Jan 21;20(1):54. doi: 10.1186/s12936-021-03583-8.

  PMID: 33478533 DERIVED

• Chaccour CJ, Alonso S, Zulliger R, Wagman J, Saifodine A, Candrinho B, Macete E, Brew J, Fornadel C, Kassim H, Loch L, Sacoor C, Varela K, Carty CL, Robertson M, Saute F. 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. BMJ Glob Health. 2018 Jan 30;3(1):e000610. doi: 10.1136/bmjgh-2017-000610. eCollection 2018.

  PMID: 29564161 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Francisco Saute, Md, MSc, PhD

  Centro de Investigacoes de Manhica

  PRINCIPAL INVESTIGATOR

• Molly Robertson, MA, MPH

  PATH

  PRINCIPAL INVESTIGATOR

• Carlos Chaccour, MD, MSc, PhD

  Barcelona Institute for Global Health

  PRINCIPAL INVESTIGATOR

• Rose Zulliger, PhD

  US Presidents Malaria Initiative, Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Abuchama Saifodine, PhD

  US Presidents Malaria Initiative, USAID

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 22, 2016
• Study Start: January 10, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); MO (1)