UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058071
Receipt number R000065631
Scientific Title Project for malaria and neglected parasitic diseases control and elimination using advanced research technique, communication tools and eco-health education
Date of disclosure of the study information 2025/09/01
Last modified on 2025/06/03 17:21:35

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Basic information

Public title

Project for malaria and neglected parasitic diseases control and elimination using advanced research technique, communication tools and eco-health education

Acronym

Project for malaria and neglected parasitic diseases control and elimination using advanced research technique, communication tools and eco-health education

Scientific Title

Project for malaria and neglected parasitic diseases control and elimination using advanced research technique, communication tools and eco-health education

Scientific Title:Acronym

Project for malaria and neglected parasitic diseases control and elimination using advanced research technique, communication tools and eco-health education

Region

Asia(except Japan)


Condition

Condition

Opisthorchiasis, Mekong schistosomiasis

Classification by specialty

Nursing Not applicable Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

"An epidemiological survey will be conducted to prevent infections of Mekong schistosomiasis and Opisthorchiasis viverrini (Thai liver fluke), along with community education programs. The aim is to investigate changes in preventive behaviors and infection status among the residents.

Basic objectives2

Others

Basic objectives -Others

A questionnaire-based survey will be administered to residents both prior to and following the intervention. The questionnaire will collect demographic information such as gender and age, as well as data on knowledge, attitudes, and practices (KAP) related to infectious diseases and their prevention. In addition, stool examinations will be conducted to assess the prevalence of infection.

The intervention will comprise educational activities utilizing various materials, including lectures, printed handouts, and video content. Community engagement will be emphasized through resident meetings and participatory approaches."

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The knowledge, attitudes, and practices (KAP) and infection prevalence among the population in Laos"

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The four villages in Champasak Province, Lao PDR, will be divided into two intervention villages and two control villages. From 2024 to 2025, educational activities will be conducted widely among the general population.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

5 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The target population includes both the general residents and school-aged children in the designated villages.

Key exclusion criteria

There are no specific exclusion criteria.

Target sample size

20000


Research contact person

Name of lead principal investigator

1st name Moritoshi
Middle name
Last name Ishigami

Organization

Japan Institute for Health Security

Division name

Research Institute

Zip code

162-8655

Address

Toyama 1-21-1, Sinjyuku, Tokyo

TEL

0332027181

Email

iwagami.m@jihs.go.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Akiyama

Organization

Nagano College of Nursing

Division name

Department of Human Science

Zip code

399-4117

Address

Akaho1694, Komagane, Nagano

TEL

0265815100

Homepage URL


Email

takeshiak@nagano-nurs.ac.jp


Sponsor or person

Institute

Nagano College of Nursing

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagano College of Nursing

Address

Akaho1694, Komagane, Nagano

Tel

0265815100

Email

takeshiak@nagano-nurs.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2025 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

3000

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2024 Year 06 Month 01 Day

Date of IRB

2024 Year 06 Month 01 Day

Anticipated trial start date

2024 Year 06 Month 01 Day

Last follow-up date

2029 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 06 Month 03 Day

Last modified on

2025 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065631