Targeting High Risk Populations With Enhanced Reactive Case Detection in Southern Lao Peoples Democratic Republic

NCT04416945 | Withdrawn DMC

• 1 other identifier: 19-27966
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses the effectiveness and feasibility of enhanced reactive case detection (RACD) targeting high-risk villages and forest workers for reducing Plasmodium falciparum and Plasmodium vivax transmission in southern Lao Peoples Democratic Republic. The authors hypothesize that enhanced community-based RACD will be more effective than standard of care case management and RACD at reducing P. falciparum and P. vivax confirmed case incidence and parasite prevalence over an 18-month period in Lao Peoples Democratic Republic.

Conditions

Plasmodium Falciparum Malaria; Plasmodium Vivax Malaria

Outcome Measures

Primary Outcomes (3)

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

  This is defined as the number of outpatient (OPD) malaria confirmed and suspected cases per person per year for each Health Center Catchment Area (HCCA), as ascertained from the health facility registers, utilizing administrative catchment population size estimates for the exposure denominator.

  4 months

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

  This is 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 (2020).

  4 months

• HS-RDT/RDT-based test positivity rate in village and forest-based reactive case detection

  This is defined as the proportion of all individuals tested by HS-RDT/RDT in response to an index cases, with a positive HS-RDT/RDT, among the population older than 18 months.

  4 months

Study Arms (2)

RACD

EXPERIMENTAL

Reactive case detection led by VMWs in response to cases in study area HCCA, with follow up testing with HS-RDTs/RDTs in both villages and forest workers; referrals for qualitative G6PD testing for P. vivax cases and 14-day PQ for G6PD non-deficient

Other: Household Reactive Case Detection; Other: RACD of cases' co-workers/co-travelers; Other: Case Management and Follow-up

Control

ACTIVE COMPARATOR

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

Other: Case Management and Follow-up

Interventions

Household Reactive Case Detection OTHER

Within 7 days of the index case notification, all members of the index case's household and everyone in the neighboring five households will then be invited to participate in the study. After consenting, a finger stick blood sample will be collected for each consenting individual for testing with the HS-RDT for P. falciparum, a standard combination RDT, and four blood spots on filter paper.

RACD

RACD of cases' co-workers/co-travelers OTHER

Index cases will be screened by the VMW at their households at the time of case investigation to determine if they have traveled or worked in a forest or forest-fringe area within the past 30 days. If eligible, the case will trigger two reactive recruitment strategies to screen and treat others who recently traveled or worked with the case in a forest or forest-fringe location: 1. Peer-referral RACD (PR-RACD): In this strategy, the case will identify specific co-travelers or co-workers resident in their village who had spent the night with the case at a forest or forest-fringe area and spent the night there in the past 30 days. 2. Venue-based RACD (VB-RACD): In this strategy, co-workers will be recruited directly from (accessible) forest or forest-fringe work sites where the index case worked and spent at least one night in the past 30 days.

RACD

Case Management and Follow-up OTHER

All individuals who test positive by either HS-RDT or Standard RDT will be told of their results and treated on site per national guidelines: * Individuals with P. falciparum infection will be treated with an age-appropriate course of artemether-lumefantrine (AL) and a single low dose of primaquine (SLD-PQ). Weight-based dosing is described in Tables 2 and 3 below. * At all study sites in Lao Peoples Democratic Republic, patients with a P. vivax infection identified by RDT (both febrile and asymptomatic) will be given a unique coded and signed informational letter directing them to the nearest district hospital (or other testing facility) for G6PD deficiency testing and possible radical cure administration depending on results. At the health facility, G6PD normal individuals will be treated with AL and a 14-day course of PQ, whereas G6PD deficient individuals will receive AL alone as per the national guidelines and referred to a hospital for further primaquine management decisions.

Control; RACD

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:

• Informed consent for participant under the age of 18 will be provided by the parent or guardian.

You may not qualify if:

• Previous participation in the study as a result of any RACD event in the past 30 days.
• Individuals with suspected severe malaria or other severe illness (including those with symptoms of severe anemia, prostration, impaired consciousness, respiratory distress, convulsions, circulatory collapse, abnormal bleeding, jaundice or passing dark urine) will be excluded from the treatment component and referred to the nearest health facility for clinical assessment and treatment

Sponsors & Collaborators

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

Study Sites (1)

Center for Malariology, Parasitology, Entomology, Laos Ministry of Health

Vientiane, Laos

Location

Related Publications (18)

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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

• Viengxay Vanisaveth, MD

  Center of Malariology, Parasitology, Entomology in Laos

  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: June 1, 2020
• First Posted: June 4, 2020
• Study Start: September 20, 2020
• Primary Completion: September 30, 2021
• Study Completion: November 1, 2021
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)