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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021781
Receipt No. R000025103
Scientific Title Efficacy of serious games in increasing HIV risk perception in Swaziland: A randomized intervention trial
Date of disclosure of the study information 2016/04/06
Last modified on 2016/04/05

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Basic information
Public title Efficacy of serious games in increasing HIV risk perception in Swaziland: A randomized intervention trial
Acronym SGprev Trial
Scientific Title Efficacy of serious games in increasing HIV risk perception in Swaziland: A randomized intervention trial
Scientific Title:Acronym SGprev Trial
Region
Africa

Condition
Condition HIV infection
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test whether a serious game intervention delivered on mobile phones to increase HIV prevention behavior and attitude.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in the proportion of participants of the intervention groups who have higher HIV risk perception between pre- and post-intervention
Key secondary outcomes -The change in the proportion of participants of the intervention groups who have higher intention to have HIV testbetween pre- and post-intervention.
-The change in the proportion of participants of the intervention groups who have higher intention to reduce multiple concurrent partnershipspre- and post-intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 <Intervention group>
People who will be voluntarily exposed to the serious game (SwaziYolo) durign the 2 week intervention period
Note: SwaziYolo is an online serious game designed to induce HIV prevetion behavior developed by our teame
Interventions/Control_2 <Delayed control group>
People who will not be allowed to access tto the SwaziYolo during the intervention period but will be allowed to do so 4 weeks after the intervention period
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
28 years-old >=
Gender Male and Female
Key inclusion criteria 1) are between 18 and 28 year of age;
2) own a smart phone running an android based operating system;
3) currently have the WhatsApp messaging application;
4) currently live in Swaziland; and
5) are able to adequately grant informed consent.
Key exclusion criteria People other than above
Target sample size 380

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Kihara
Organization School of Public Health, Graduate School of Medicine, Kyoto University
Division name Department of Global Health and Socio-epidemiology
Zip code
Address YoshidaKonoe-cho, Sakyo-ku, Kyoto 606-8501
TEL 075-753-4350
Email kihara.masahiro.4n@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Bhekumusa Wellington Lukhele
Organization School of Public Health, Graduate School of Medicine, Kyoto University
Division name Department of Global Health and Socio-epidemiology
Zip code
Address YoshidaKonoe-cho, Sakyo-ku, Kyoto 606-8501
TEL 075-753-4350
Homepage URL
Email bhekumusa.lukhele.36x@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Hayao Nakayama Foundation for Science &Technology and Culture
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
Address
Tel
Email

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
2016 Year 04 Month 06 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
2016 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 05 Day
Last modified on
2016 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103

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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