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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048972
Receipt No. R000055776
Scientific Title Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Date of disclosure of the study information 2022/09/20
Last modified on 2022/09/20

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Basic information
Public title Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Acronym Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Scientific Title Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Scientific Title:Acronym Examining the Effects of Film-based Intervention on Sexual and Reproductive Health-seeking Intention and Behavior of Cambodian Youth: A Randomized Controlled Trial
Region
Asia(except Japan)

Condition
Condition Healthy
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the effects of film-based intervention on SRH seeking intention of Cambodian youth aged 18-24 in Cambodia.
Basic objectives2 Others
Basic objectives -Others - Examine the effects of film-based intervention on SRH seeking behavior of Cambodian youth aged 18-24 in Cambodia
- Determine the perception of Cambodian youth, aged 18-24 in Cambodia, on the accessibility and reliability of sources of SRH information
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes The outcomes for this study are SRH seeking intention and behavior. SRH seeking intention is the desire to find SRH information, whereas SRH seeking behavior is performing the action of actively looking for SRH information from various sources. Their SRH seeking intention and behavior will be measured by their level of self-efficacy towards finding SRH information and perception of the level of reliability and accessibility of sources of SRH information.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Participants of the intervention arm will first be introduced to the title of the film, which will hint the main topic(s) of the intervention. Participants will continue to watch the film just as they would when consuming an online video. The film will explore the character's issue as the story unfolds. However, the participants will be presented with the story in a way that is dramatic and urgent that can be somewhat personal within the context of film, and allows for the participant to be more empathetic with the character. The film will not only show the character facing the problem, but will also show the methods and steps that the character in the film takes to solve the issue. At the end of the film intervention, contact information to a local youth-friendly service will be provided to the participant.
Interventions/Control_2 Participants of the control arm will first be introduced to the main topic(s) of the text-based intervention. They will start reading the text-based intervention in which a character is faced with a SRH related situation. The scenario will continue to elaborate the chracter's issue until the end of the story. Then, the participant will be presented with possible steps that the character should take to approach the issue. Ultimately, contact information to a local youth-friendly service will be available at the end of the intervention.
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
18 years-old <=
Age-upper limit
24 years-old >=
Gender Male and Female
Key inclusion criteria The participants of this study will be youths aged 18 to 24 who are living in Cambodia and have access to the Internet via a personal computer or a smartphone at the time of data collection.
Key exclusion criteria Those who are unable to watch the film intervention, read the text-based intervention, respond to questions in Khmer language, and/or are not able to use the Internet will be excluded from the study.
Target sample size 334

Research contact person
Name of lead principal investigator
1st name Inrasothythep
Middle name
Last name Neth
Organization The University of Tokyo
Division name Department of Community and Global Health, Graduate School of Medicine
Zip code 113-0033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 070-4422-5240
Email inrasothythep.neth@gmail.com

Public contact
Name of contact person
1st name Inrasothythep
Middle name
Last name Neth
Organization The University of Tokyo
Division name Department of Community and Global Health, Graduate School of Medicine
Zip code 113-0033
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 070-4422-5240
Homepage URL
Email inrasothythep.neth@gmail.com

Sponsor
Institute Not applicable
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (21H03160)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee, Graduate School of Medicine, The University of Tokyo
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan, 113-0033
Tel 03-5841-0818
Email ethics@m.u-tokyo.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
2022 Year 09 Month 20 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
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 Preinitiation
Date of protocol fixation
2022 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2022 Year 10 Month 01 Day
Last follow-up date
2023 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 09 Month 20 Day
Last modified on
2022 Year 09 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055776

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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