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

NCT05052502 | Completed DMC

• 1 other identifier: 19-04062020
• Study Type: interventional
• Target: 14,977
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasmodium Falciparum Malaria; Plasmodium Vivax Malaria

Outcome Measures

Primary Outcomes (2)

• Confirmed P. falciparum and P. vivax malaria parasite incidence

  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.

  3 months

• PCR-based P. falciparum and P. vivax parasite prevalence in sampled sub-districts

  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.

  3 months

Secondary Outcomes (6)

• Population coverage of rfMDA interventions

  3 months

• Feasibility of conducting rfMDA at the community level

  3 months

• Acceptability of rfMDA approach

  3 months

• Adverse event rate

  3 months

• Operational feasibility of glucose-6-phosphate dehydrogenase (G6PD) testing and referral

  3 months

Study Arms (2)

reactive focal mass drug administration (rfMDA)

EXPERIMENTAL

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.

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

Control

ACTIVE COMPARATOR

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

Other: Case Management and Follow-up

Interventions

Case Management and Follow-up OTHER

Individuals will be told of their test result and a positive test result on either RDT will prompt treatment as per the national treatment guidelines. * Individuals with P. falciparum infection will be treated with an age-appropriate course of dihydroartemisinin/piperaquine (DHAP) or artesunate-pyronaridine (Pyramax) and PQ. * At all study sites in Thailand, patients with a P. vivax infection identified by the standard combination RDT will be tested by the VMV and Health Promotion Hospital (HPH) staff member using the quantitative G6PD RDT. G6PD normal individuals will be treated with Chloroquine (CQ) and a 14-day course of primaquine (PQ). G6PD deficient individuals will receive CQ alone and referred to the nearest health facility for further primaquine management decisions.

Control; reactive focal mass drug administration (rfMDA)

Reactive focal mass drug administration (rfMDA) OTHER

Reactive focal mass administration (rfMDA) will be implemented around the index case household and to forest co-workers/co-travelers in Thailand. The VMV will conduct the investigation visit within 7 days after the notification of the index case. All members of the index case's household as well as all members of the nearest five households around the index case's household, including temporary visitors will be invited to participate in the study and to be treated for malaria without a malaria test. After obtaining participants' or parents/guardians' consent, the VMV will proceed with the participant questionnaire, and all consenting household members will be tested for G6PD using the G6PD quantitative test prior to administration of antimalarials. For rfMDA, all eligible participants will be offered artesunate-mefloquine (AS-MQ). Per national policy, a 14-day course of primaquine will be administered to G6PD non-deficient study participants.

reactive focal mass drug administration (rfMDA)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Center for Malariology, Parasitology, and Entomology: collaborator
• University of Massachusetts, Amherst: collaborator
• Centers for Disease Control and Prevention: collaborator
• Tulane University School of Public Health and Tropical Medicine: collaborator

Study Sites (1)

Division of Vector Born Diseases, Ministry of Health

Bangkok, Thailand

Location

Related Publications (19)

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MeSH Terms

Conditions

Malaria, Falciparum; Malaria, Vivax

Interventions

Case Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Adam Bennett, MA, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Cheewanan Lertpiriyasuwat, MD

  Ministry of Health, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: November 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)