UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021781 |
|---|---|
| Receipt number | 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 12:25:10 |
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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
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
bhekumusa.lukhele.36x@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
