Clinical trial NCT05052502: Targeting High Risk Populations With Enhanced Reactive Focal Mass Drug Administration in Thailand
Official title: Targeting High-risk Populations With Enhanced Reactive Focal Mass Drug Administration: A Study to Assess the Effectiveness and Feasibility for Plasmodium Falciparum and Plasmodium Vivax Malaria in Thailand
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plasmodium Falciparum Malaria
Plasmodium Vivax Malaria
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Center for Malariology, Parasitology, and Entomology
name: Tulane University School of Public Health and Tropical Medicine
name: University of Massachusetts, Amherst
name: Centers for Disease Control and Prevention
First posted: 2021-09-22
Enrollment: 49118
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

Eligibility 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.

Primary outcomes:
measure: Confirmed P. falciparum and P. vivax malaria parasite incidence
timeFrame: 3 months
measure: PCR-based P. falciparum and P. vivax parasite prevalence in sampled sub-districts
timeFrame: 3 months
Secondary outcomes:
measure: Population coverage of rfMDA interventions
timeFrame: 3 months
measure: Feasibility of conducting rfMDA at the community level
timeFrame: 3 months
measure: Acceptability of rfMDA approach
timeFrame: 3 months
measure: Adverse event rate
timeFrame: 3 months
measure: Operational feasibility of glucose-6-phosphate dehydrogenase (G6PD) testing and referral
timeFrame: 3 months
measure: Assessment of P. vivax treatment adherence
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Vector Born Diseases, Ministry of Health
Study officials:
affiliation: University of California, San Francisco
name: Adam Bennett, MA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health, Thailand
name: Cheewanan Lertpiriyasuwat, MD
role: PRINCIPAL_INVESTIGATOR
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