Clinical trial NCT04416945: Targeting High Risk Populations With Enhanced Reactive Case Detection in Southern Lao Peoples Democratic Republic
Official title: Targeting High-risk Populations With Enhanced Reactive Case Detection: a Study to Assess the Effectiveness and Feasibility for Reducing Plasmodium Falciparum and P. Vivax Malaria in Southern Lao Peoples Democratic Republic
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: 2020-06-04
Enrollment: 31443
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 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.

Detailed description: In the Greater Mekong Subregion (GMS), the risk of malaria infection is often due not to village-based transmission but rather to occupational and behavioral risk factors leading to exposure in forest settings. Additionally, a substantial portion of infections are asymptomatic and/or submicroscopic, limiting the scope of current diagnostics and surveillance approaches. The proposed research will evaluate the effectiveness of reactive case detection (RACD) using highly-sensitive rapid diagnostic tests (HS-RDTs), targeting both village and forest working populations, compared to control for reducing the health center catchment-level incidence and prevalence of P. falciparum and P. vivax within two provinces in Lao People's Democratic Republic.

To test this hypothesis, this study will employ a cluster randomized controlled trial design with two comparison arms: (1) Control: standard of care - passive case management provided through community-based Village Malaria Workers (VMWs) and existing health facilities; includes village-based RACD with conventional rapid diagnostic tests (RDTs) conducted by district surveillance teams and (2) enhanced community-based RACD: RACD conducted by community-based VMWs using both HS-RDTs and conventional RDTs within villages and among forest workers.

The primary outcome measures to assess effectiveness include P. falciparum and P. vivax confirmed case incidence over the study period; PCR-based P. falciparum and P. vivax prevalence at end line; and HS-RDT test positivity rate in village and forest worker RACD. Secondary outcomes measures will examine the operational feasibility, safety, and acceptability of VMW-led reactive approaches and glucose-6-phosphate dehydrogenase (G6PD) testing, referral to district or provincial-level facilities, safety and treatment adherence for P. vivax cases.

Eligibility criteria: RACD:

- Inclusion Criteria

* Inclusion Criteria for 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 health facility catchment area, or worked or spent at least one night at a forest or forest-fringe site in the past 30 days located within an intervention health facility catchment area
* Inclusion criteria for village residents: Lives in a village within a selected intervention health facility catchment area and in one of the five households closest to the residence of an index case of malaria
* Inclusion criteria for 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 health facility catchment area as an index case of malaria
* Inclusion criteria for all participants: Willing and available to participate in the study

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

- Exclusion Criteria:

* 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

Primary outcomes:
measure: Confirmed P. falciparum and P. vivax malaria parasite incidence
timeFrame: 4 months
measure: PCR-based P. falciparum and P. vivax parasite prevalence in sampled HCCAs
timeFrame: 4 months
measure: HS-RDT/RDT-based test positivity rate in village and forest-based reactive case detection
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vientiane
country: Lao People's Democratic Republic
facility: Center for Malariology, Parasitology, Entomology, Laos Ministry of Health
Study officials:
affiliation: University of California, San Francisco
name: Adam Bennett, MA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of Malariology, Parasitology, Entomology in Laos
name: Viengxay Vanisaveth, MD
role: PRINCIPAL_INVESTIGATOR
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