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Cost-effectiveness Evaluation of Vector Control Strategies in Mozambique (COST)

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ClinicalTrials.gov Identifier: NCT02910934
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Abt Associates
Centers for Disease Control and Prevention
Ministry of Health, Mozambique
Centro de Investigacao em Saude de Manhica
Information provided by (Responsible Party):
PATH

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.


Condition or disease Intervention/treatment Phase
Malaria Other: Actellic CS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3915 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Cost-effectiveness Evaluation of Vector Control Strategies in Mozambique
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: IRS
This arm is comprised of village clusters that have received indoor residual spray with Actellic CS.
Other: Actellic CS
Indoor residual spray with Actellic CS

No Intervention: non-IRS
This arm is comprised of village clusters that will not receive indoor residual spray



Primary Outcome Measures :
  1. Cost per case averted in children five years of age and under at health facility level by adding Actellic-IRS [ Time Frame: 24 months ]
    Incidence at health facility level by passive case detection (with enhanced surveillance and quality control) along with implementation costing data using an ingredients approach


Secondary Outcome Measures :
  1. Entomological Indicators [ Time Frame: 24 months ]
    Entomological measurements including descriptions of vector densities, estimates of human biting rates, sporozoite rates, measures of indoor and outdoor feeding behaviors, insecticide resistance patterns and estimates of entomological inoculation rates (EIR)

  2. Parasite prevalence [ Time Frame: 12 months ]
    Changes in community-based parasitaemia measured through cross-sectional surveys

  3. Health Behavior [ Time Frame: 24 months ]
    Changes in malaria avoidance and health seeking behavior through cohort surveys and cross-sectional surveys

  4. Cost per malaria case averted in children five years of age and under at the community [ Time Frame: 24months ]
    Derived from incidence in children five years of age and under at the community levels by active case detection along with implementation costing data using an ingredients approach



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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • all infants 0-6 months of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910934


Locations
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United States, District of Columbia
Molly Robertson
Washington, District of Columbia, United States, 20010
Mozambique
Centro de Investigacoes de Manhica
Manhica, Maputo, Mozambique
Sponsors and Collaborators
PATH
United States Agency for International Development (USAID)
Abt Associates
Centers for Disease Control and Prevention
Ministry of Health, Mozambique
Centro de Investigacao em Saude de Manhica
Investigators
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Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02910934    
Other Study ID Numbers: 946238-1 (EOM)
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by PATH:
Indoor Residual Spray
IRS
Insecticide Treated Net
LLIN
ITN
Long lasting insecticidal net
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases