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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037065
Receipt No. R000042232
Scientific Title Positive deviance for dual-method promotion among women in Uganda
Date of disclosure of the study information 2019/06/14
Last modified on 2020/08/09

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Basic information
Public title Positive deviance for dual-method promotion among women in Uganda
Acronym Positive deviance for dual-method promotion
Scientific Title Positive deviance for dual-method promotion among women in Uganda
Scientific Title:Acronym Positive deviance for dual-method promotion
Region
Africa

Condition
Condition Healthy adult female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of an 8-month health education formulated under the positive deviance approach on dual-method use among women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dual-method selection and adherence in the last two months, prior to each follow-up interview
Key secondary outcomes Self-reported first occurrence of pregnancy and STIs in the last two months, prior to each follow-up interview
Communication about HIV/STI risk with partners in the last two months, prior to each follow-up interview

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The following Interventions formulated based on unique practice identified in the study area in addition to regular family planning counseling:

-Dual-method use counseling (1 time: on the day of enrollment)
-Participatory learning workshop (1 time: 2 weeks after the enrollment)
-Bimonthly telephone counseling (3 time: 3, 5 and 7 months after the enrollment)
Interventions/Control_2 The following Interventions using existing materials in addition to regular family planning counseling:

-Dual-method use counseling (1 time: on the day of enrollment)
-Bimonthly phone calls on family planning and HIV/STI risk (3 time: 3, 5 and 7 months after the enrollment)
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
49 years-old >
Gender Female
Key inclusion criteria -Women
-18-49 years old
-Sexually active
-Using HECs at the time of recruitment
-Have a desire to avoid pregnancy for 12 months from recruitment
-Have a husband or live-in sexual partner
-Have access to a working phone number
Key exclusion criteria -Pregnant women and women who are infertile for other reasons
-Women who used dual-method use in the last two months prior to the recruitment
Target sample size 960

Research contact person
Name of lead principal investigator
1st name Masamine
Middle name
Last name Jimba
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Community and Global Health
Zip code 113-0033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL 03-5841-3698
Email ohjimba@gmail.com

Public contact
Name of contact person
1st name Hodaka
Middle name
Last name Kosugi
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Community and Global Health
Zip code 113-0033
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL +256-772-147034
Homepage URL
Email hodakos@gmail.com

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization FASID Scholarship Program
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Mbarara University of Science and Technology, Uganda
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Research Ethics Committee of the Graduate School of Medicine, the University of Tokyo, Japan
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
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
2019 Year 06 Month 14 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 980
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 No longer recruiting
Date of protocol fixation
2019 Year 06 Month 10 Day
Date of IRB
2019 Year 07 Month 29 Day
Anticipated trial start date
2019 Year 10 Month 20 Day
Last follow-up date
2020 Year 03 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
2019 Year 06 Month 14 Day
Last modified on
2020 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042232

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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