UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050136 |
|---|---|
| Receipt number | R000057115 |
| Scientific Title | Examining the Effectiveness of a Community-Based Program to Protect Lower Caste Women from Sexual Violence in India: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/01/25 |
| Last modified on | 2023/01/25 21:48:14 |
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Basic information
Public title
Trial of a Community-Based Program to Protect Lower Caste Women from Sexual Violence in India
Acronym
GAWAIN Study
Scientific Title
Examining the Effectiveness of a Community-Based Program to Protect Lower Caste Women from Sexual Violence in India: A Randomized Controlled Trial
Scientific Title:Acronym
GAWAIN study
Region
| Asia(except Japan) |
Condition
Condition
Sexual violence
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to distribute crime prevention buzzers to women living in slums in India, as well as to provide psychoeducation on sexual violence prevention to local residents, and to examine their effectiveness in preventing sexual violence through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Event of sexual violence during the 6-months trial period (Stalking, touching, peeping, underware theft, sexual assault, rape)
Key secondary outcomes
Trust, Well-being, QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Distribution of crime prevention buzzers
Psychoeducation
Interventions/Control_2
No 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
| Not applicable |
Gender
Female
Key inclusion criteria
Residing in designated blocks within the study area
Key exclusion criteria
Inability to communicate in English or Hindi
A criminal record other than possession or use of illegal drugs in the past
A serious mental or physical illness
Someone in the same household who has already been selected as a participant
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takayuyki |
| Middle name | |
| Last name | Harada |
Organization
University of Tsukuba
Division name
Faculty of Human Scioences
Zip code
112-0012
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3942-5188
tkharada@human.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Sakurai |
Organization
GAWAIN
Division name
CEO
Zip code
150-0002
Address
2-7-14-302 Shibuya, Shikuya-ku, Tokyo
TEL
03-3942-5188
Homepage URL
contact@sirgawain.org
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Takayuki Harada
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
3-29-1 Otsuka, Bunkyo-ku, Tokyo
Tel
03-3942-6919
hitorinri@un.tsukuba.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
筑波大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
484
Results
Stalking was significantly less in the intervention group (3 vs 12)(Chi2(1)=4.40, p<0.05). Similarly, molestation was significantly less in the intervention group (4 vs 17) (Chi2(1)=6.70, p<0.01). There were no other significant differences in victimization for obscene word, peeping, and exposure. Psychological scales were also administered at the end of the study. Comparing the results, there was no significant between-group differences.
Results date posted
| 2023 | Year | 01 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 10 | Day |
Baseline Characteristics
Adult women residing in three camps in slums in metropolitan India.
Participant flow
The following dropout/withdrawal criteria were applied.
-Explicit statement of withdrawal from study participation
-Failure to comply with institutional regulations.
During the trial, 16 participants were dropped out.
Adverse events
None
Outcome measures
Event of sexual victimazation dunring the 6-months-trial
Psychological scales (feeling of trust, well-being, QOL)
Plan to share IPD
None
IPD sharing Plan description
NA
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2023 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057115
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