UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of serious games in increasing HIV risk perception in Swaziland: A randomized intervention trial
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masahiro Kihara
Organization	School of Public Health, Graduate School of Medicine, Kyoto University
Division name	Department of Global Health and Socio-epidemiology
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	Bhekumusa Wellington Lukhele
Organization	School of Public Health, Graduate School of Medicine, Kyoto University
Division name	Department of Global Health and Socio-epidemiology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000025103