Targeting High Risk Populations With Enhanced Reactive Focal Mass Drug Administration in Thailand

Not Applicable

• Conditions: Plasmodium Falciparum Malaria; Plasmodium Vivax Malaria
• Interventions: Other: Case Management and Follow-up; Other: Reactive focal mass drug administration (rfMDA)

• Registration Number: NCT05052502
• Lead Sponsor: University of California, San Francisco

Brief Summary

This study assesses the effectiveness of reactive focal mass drug administration (rfMDA), targeting both village and forest working populations, compared to control for reducing the health promotion hospital-level (sub-district) incidence and prevalence of P. falciparum and P. vivax within five provinces in Thailand.

Detailed Description

Thailand currently has a well-developed and robust surveillance system based on detailed mapping of all cases to the village foci level and stratification of response. In fiscal year 2019, 5,833 cases of malaria were reported with 83.0% P. vivax and 12.9% P. falciparum; nine deaths were reported. This represents a 20.8% decrease in total cases from fiscal year 2018. Currently, there are 701 "A1" villages in 44 provinces.

The research proposed here will evaluate the effectiveness and feasibility of enhanced reactive focal mass drug administration, results of which will have direct implications for continued roll out the community-led foci management, providing practical guidance that other malaria programs can utilize. Responding to the malaria among high risk populations is a requirement from the National Malaria Elimination Strategy in Thailand. Additionally, Thailand has experienced outbreaks related to forest work over the past several years, and consequently the Department of Vector Borne Disease (DVBD) is interested in introducing more aggressive parasite elimination strategies, including rfMDA for P. falciparum and P. vivax specifically targeting high-risk populations to interrupt transmission and rapidly accelerate elimination.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49118

Inclusion Criteria

Not provided

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Exclusion Criteria

• For rfMDA:

• Previous participation in the study as a result of any rfMDA event in the past 30 days
• Individuals with severe disease or drug contra-indications will be excluded from the treatment component only
• Artesunate-Mefloquine: Pregnancy in the first trimester, or known drug allergy
• Use of Mefloquine within 60 days of first treatment prior to enrollment date.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
reactive focal mass drug administration (rfMDA)	Case Management and Follow-up	Reactive FMDA (rfMDA) led by VMVs in response to cases in study area sub-district, in both villages and forest workers; quantitative G6PD testing for all individuals and 14-day PQ for G6PD non-deficient.
reactive focal mass drug administration (rfMDA)	Reactive focal mass drug administration (rfMDA)	Reactive FMDA (rfMDA) led by VMVs in response to cases in study area sub-district, in both villages and forest workers; quantitative G6PD testing for all individuals and 14-day PQ for G6PD non-deficient.
Control	Case Management and Follow-up	Standard of care including case management through health facilities and malaria posts/VMVs; village-based RACD conducted by district staff in some areas.

Primary Outcome Measures

Name	Time	Method
PCR-based P. falciparum and P. vivax parasite prevalence in sampled sub-districts	3 months	Defined as the proportion of individuals ≥18 months old with P. falciparum or P. vivax infection (detected by PCR) out of all individuals ≥18 months tested within the end line survey.
Confirmed P. falciparum and P. vivax malaria parasite incidence	3 months	Defined as the number of outpatient (OPD) malaria confirmed and suspected cases per person per year for each sub-district, as ascertained from the health facility registers, utilizing administrative catchment population size estimates for the exposure denominator.

Secondary Outcome Measures

Name	Time	Method
Adverse event rate	3 months	Safety measures will include the adverse event rate amongst treated individuals and hemoglobin measurement pre and post treatment for individuals receiving PQ.
Acceptability of rfMDA approach	3 months	Acceptability will be determined based upon refusal rates during interventions and responses of community members and VMWs to end line questionnaire, interviews, and focus groups.
Population coverage of rfMDA interventions	3 months	This indicator will be measured in two ways. Operational program coverage will be defined as the proportion of individuals ≥18 months old and households visited and offered the rfMDA interventions within the target areas per time period. Effective program coverage is defined as the proportion of individuals (≥18 months old) that agreed to participate in the rfMDA intervention among all individuals ≥18 months old eligible to participate in the intervention in the target population per time period.
Feasibility of conducting rfMDA at the community level	3 months	Feasibility will be determined based upon a combination of population coverage data, responses of provincial, district, and health staff, VMWs, and community members to interviews and focus groups at baseline and end line, village malaria workers (VMWs) competency checklists at baseline, midline, and end line, and cost data.
Operational feasibility of glucose-6-phosphate dehydrogenase (G6PD) testing and referral	3 months	Operational feasibility of G6PD testing and referral will be determined by responses of health staff and VMWs to interviews and focus groups at baseline and end line and competency checklists at baseline, midline, and end line, the proportion of P. vivax cases with a valid G6PD result, and proportion of referred cases presenting at a health facility for G6PD testing.
Assessment of P. vivax treatment adherence	3 months	Treatment adherence will be determined by the proportion of P. vivax cases with physical evidence of adherence through pill count and the P. vivax relapse rate across study arms.

Trial Locations

Locations (1)

Division of Vector Born Diseases, Ministry of Health; 🇹🇭 Bangkok, Thailand