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

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

Interventions

OTHER

Household Reactive Case Detection

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.

OTHER

RACD of cases' co-workers/co-travelers

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.

OTHER

Case Management and Follow-up

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.

Sponsors & Collaborators

• Center for Malariology, Parasitology, and Entomology

  collaborator UNKNOWN

• Tulane University School of Public Health and Tropical Medicine

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• University of Massachusetts, Amherst

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Adam Bennett, MA, PhD · University of California, San Francisco

• Viengxay Vanisaveth, MD · Center of Malariology, Parasitology, Entomology in Laos

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-20

Primary Completion

2021-09-30

Completion

2021-11-01

Countries

• Laos

Study Locations