Targeted Active Case Detection Among High Risk Populations in Southern Lao Peoples Democratic Republic

Summary

This study assesses the effectiveness of targeted active case detection among high-risk populations in Southern Lao Peoples Democratic Republic (PDR). The investigators hypothesize that active case detection using the next generation of HRP-2 rapid diagnostic tests (RDTs) can help bridge gaps in identification of high-risk asymptomatic individuals with low density parasitemia, allowing for targeting of this reservoir and thereby reducing transmission. The investigators hypothesize that active case detection (testing and treating positive cases) with these RDTs will lead to a reduction in P. falciparum transmission.

Conditions

• Plasmodium Falciparum Malaria

Interventions

DIAGNOSTIC_TEST

Standard RDT and HS-RDT

All household members (residents and temporary visitors) aged 18 months and older will be invited to participate in an RDT and blood collection component. After consenting, the MTAT team will capture axillary temperature, and test each individual using both a standard RDT (SD Bioline Pf/Pv RDT) and HS-RDT (SD Bioline Malaria Ag P.f High Sensitive Cat# 05FK140)

DIAGNOSTIC_TEST

Standard RDT and HS-RDT

All individuals will be invited to participate in an RDT and blood collection component. Informed consent will be obtained from all participants. After consenting, the PNs will capture axillary temperature, and test each individual using both a standard RDT (SD Bioline Pf/Pv RDT) and HS-RDT (SD Bioline Alere Malaria Ag Pf High Sensitive Cat #05FK140). Dried blood spots (DBS) will also be collected on all HRPs if deemed feasible.

DRUG

Artemether-lumefantrine

If found positive by standard RDT or HS-RDT, treatment will be administered, and women of reproductive age will be assessed as outlined in the protocol. All individuals who have provided informed consent, test positive by either HS-RDT or standard RDT, are ≥18 months old, are not pregnant or breastfeeding, and who do not have symptoms associated with severe malaria or another severe illness, will be offered an age-appropriate course of AL (age-specific blister packages) and SLD-PQ according to national treatment guidelines.

DRUG

Primaquine Phosphate

If found positive by standard RDT or HS-RDT, treatment will be administered, and women of reproductive age will be assessed as outlined in the protocol. All individuals who have provided informed consent, test positive by either HS-RDT or standard RDT, are ≥18 months old, are not pregnant or breastfeeding, and who do not have symptoms associated with severe malaria or another severe illness, will be offered an age-appropriate course of AL (age-specific blister packages) and SLD-PQ according to national treatment guidelines.

Sponsors & Collaborators

• Center for Malariology, Parasitology, and Entomology

  collaborator UNKNOWN

• The National Institute of Public Health

  collaborator UNKNOWN

• Health Poverty Action

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-28

Primary Completion

2018-11-30

Completion

2018-12-31

Countries

• Laos

Study Locations