Evidence map›Paper›PMID 38922648›Full record

Trial reportJMIR public health and surveillance2024

Effectiveness, Safety, and Acceptability of Primaquine Mass Drug Administration in Low-Endemicity Areas in Southern Thailand: Proof-of-Concept Study.

Jaranit Kaewkungwal, Wanlapa Roobsoong, Saranath Lawpoolsri, Wang Nguitragool, Suwich Thammapalo, Pathomporn Prikchoo, Amnat Khamsiriwatchara, Rungrawee Pawarana, Pawinee Jarujareet, Daniel M Parker and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in JMIR public health and surveillance, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Jaranit Kaewkungwal *Department of Tropical Hygiene, Mahidol University, Bangkok, Thailand.ORCID 0000-0001-7916-8460
Wanlapa RoobsoongMahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID 0000-0002-1789-0439
Saranath LawpoolsriDepartment of Tropical Hygiene, Mahidol University, Bangkok, Thailand.ORCID 0000-0003-4841-7924
Wang NguitragoolDepartment of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID 0000-0002-5484-7130
Suwich ThammapaloMinistry of Public Health, Nonthaburi, Thailand.ORCID 0009-0007-2858-4748
Pathomporn PrikchooMinistry of Public Health, Nonthaburi, Thailand.ORCID 0009-0007-7171-6910
Amnat KhamsiriwatcharaCenter of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID 0000-0001-9715-6658
Rungrawee PawaranaCenter of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID 0000-0003-4401-8803
Pawinee JarujareetCenter of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID 0009-0004-2972-0076
Daniel M ParkerDepartment of Population Health and Disease Prevention, University of California, Irvine, Irvine, CA, United States.ORCID 0000-0002-5352-7338
Piyarat SripooroteMahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID 0009-0004-1590-6654
Mondha KengganpanichDepartment of Health Education and Behavioral Sciences, Faculty of Public Health, Mahidol University, Bangkok, Thailand.ORCID 0009-0008-7125-0193
Chetta NgamjarusDepartment of Epidemiology and Biostatistics, Faculty of Public Health, Khon Kaen University, Khon Kaen, Thailand.ORCID 0000-0002-5737-5941
Jetsumon SattabongkotMahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.ORCID 0000-0002-3938-4588
Liwang CuiDivision of Infectious Diseases and Internal Medicine, Department of Internal Medicine, University of South Florida, Tampa, FL, United States.ORCID 0000-0002-8338-1974

Funding

Southeast Asia Malaria Research CenterU19AI089672 · NIAID · UNIVERSITY OF SOUTH FLORIDA · PI CUI, LIWANG · 2010 to 2023
$28.9M
NIAID NIH HHS U19 AI089672
6 · The paper itself

Abstract

backgroundA challenge in achieving the malaria-elimination target in the Greater Mekong Subregion, including Thailand, is the predominance of Plasmodium vivax malaria, which has shown extreme resilience to control measures.

objectiveThis proof-of-concept study aimed to provide evidence for implementing primaquine mass drug administration (pMDA) as a strategy for P. vivax elimination in low-endemicity settings.

methodsThe study employed a mixed-methods trial to thoroughly evaluate the effectiveness, safety, acceptability, and community engagement of pMDA. The quantitative part was designed as a 2-period cluster-crossover randomized controlled trial. The intervention was pMDA augmented to the national prevention and control standards with directly observed treatment (DOT) by village health volunteers. The qualitative part employed in-depth interviews and brainstorming discussions. The study involved 7 clusters in 2 districts of 2 southern provinces in Thailand with persistently low P. vivax transmission. In the quantitative part, 5 cross-sectional blood surveys were conducted in both the pMDA and control groups before and 3 months after pMDA. The effectiveness of pMDA was determined by comparing the proportions of P. vivax infections per 1000 population between the 2 groups, with a multilevel zero-inflated negative binomial model adjusted for cluster and time as covariates and the interaction. The safety data comprised adverse events after drug administration. Thematic content analysis was used to assess the acceptability and engagement of stakeholders.

resultsIn the pre-pMDA period, the proportions of P. vivax infections in the pMDA (n=1536) and control (n=1577) groups were 13.0 (95% CI 8.2-20.4) and 12.0 (95% CI 7.5-19.1), respectively. At month 3 post-pMDA, these proportions in the pMDA (n=1430) and control (n=1420) groups were 8.4 (95% CI 4.6-15.1) and 5.6 (95% CI 2.6-11.5), respectively. No statistically significant differences were found between the groups. The number of malaria cases reduced in all clusters in both groups, and thus, the impact of pMDA was inconclusive. There were no major safety concerns. Acceptance among the study participants and public health care providers at local and national levels was high, and they believed that pMDA had boosted awareness in the community.

conclusionspMDA was associated with high adherence, safety, and tolerability, but it may not significantly impact P. vivax transmission. As this was a proof-of-concept study, we decided not to scale up the intervention with larger clusters and samples. An alternative approach involving a targeted primaquine treatment strategy with primaquine and DOT is currently being implemented. We experienced success regarding effective health care workforces at point-of-care centers, effective collaborations in the community, and commitment from authorities at local and national levels. Our efforts boosted the acceptability of the malaria-elimination initiative. Community engagement is recommended to achieve elimination targets.

trial registrationThai Clinical Trials Registry TCTR20190806004; https://www.thaiclinicaltrials.org/show/TCTR20190806004.

Indexed as

AntimalarialsMalaria, VivaxMass Drug AdministrationPrimaquineAdolescentAdultChildCross-Over StudiesCross-Sectional StudiesFemaleHumansMaleMiddle AgedPatient Acceptance of Health CareProof of Concept StudyThailandAntimalarialsPrimaquinecluster-crossover randomized controlled trialcommunity-based trialmass drug administrationparticipatory epidemiologyPlasmodium vivaxprimaquine

Identifiers

PMID38922648
PMCPMC11237773

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.