UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037065 |
|---|---|
| Receipt number | 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 | 2021/06/20 17:31:54 |
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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
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
hodakos@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
960
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
Main results already published
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 | 07 | Month | 05 | 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
| 2021 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042232
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
