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

University of California San Francisco (UCSF)

Status: Unknown

Conditions: Plasmodium Vivax Malaria; Plasmodium Falciparum Malaria

Treatments: Other: Reactive focal mass drug administration (rfMDA); Other: Case Management and Follow-up

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05052502

19-04062020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49,118 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for rfMDA:

• Index cases: Presented as a confirmed malaria case to an intervention health facility or village malaria worker, and lives in a village within a selected intervention subdistrict, or worked or spent at least one night at a forest or forest-fringe site in the past 30 days located within an intervention subdistrict
• Village residents: Lives in a village within a selected intervention subdistrict area and in one of the five households closest to the residence of an index case of malaria
• Co-worker/traveler referral: Worked or traveled and spent at least one night in forest in past 30 days in same location within an intervention subdistrict as an index case of malaria
• All participants: Willing and available to participate in the study and informed consent for participant under the age of 18 will be provided by the parent or guardian. Participants for focus group discussions (FGDs) and key informant interviews (KIIs); 18 years of age or older

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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49,118 participants in 2 patient groups

reactive focal mass drug administration (rfMDA)

Experimental group

Description:

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.

Treatment:

Other: Reactive focal mass drug administration (rfMDA)

Other: Case Management and Follow-up

Control

Active Comparator group

Description:

Standard of care including case management through health facilities and malaria posts/VMVs; village-based RACD conducted by district staff in some areas.

Treatment:

Other: Case Management and Follow-up