UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
Acronym	The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
Scientific Title	The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
Scientific Title:Acronym	The effectiveness of a behavioral science and design intervention for family savings on increased use of maternal health services and male involvement: a randomized controlled trial
Region	Africa

Condition
Condition	Financial savings, maternal Health Service Utilization
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the effectiveness of a behavioral intervention designed to encourage financial savings for healthcare costs among pregnant women and their partners in Uganda. To examine whether increased earmarked financial savings for healthcare costs leads to increased utilization of maternal health services and male involvement in maternal healthcare.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is usage of maternal health services, assessed by antenatal care attendance (ANC), skilled birth attendance, and birth at a health facility, as well as the amount of validated expenditure in participants' clinicPesa accounts from the day of enrollment during the intervention period.
Key secondary outcomes	Secondary outcomes include male involvement in maternal healthcare, measured by financial support, attendance to ANC, assisting with planning the delivery, and providing perceived emotional support to the mother, as well as total savings for healthcare, assessed using the validated amount of savings accrued in participants' clinicPesa accounts from the day of enrollment plus any withdrawals for healthcare expenditures during the intervention period.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
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 intervention was formulated using behavioral science approaches for promoting health savings towards the costs of maternal health care among pregnant women and their partners. The intervention consists of a basic mobile money health savings account offered by clinicPesa and additional behavioral designs to encourage savings for maternal health costs. In the intervention group, participants receive the standard clinicPesa offering in addition to behavioral designs that encourage saving. The intervention group will also have fun designs that encourage savings, such as gold coin "rewards," an animated smiling baby character, and other designs to help them keep track of savings targets, such as reminder SMS messages that sound like they are from their child. In the control group, participants receive the standard clinicPesa offering (a mobile money savings account with interest and basic SMS reminders). Both groups will have access to a smartphone application that has a mobile money health savings account as offered by clinicPesa with the ability to deposit and withdraw health savings or set targets.
Interventions/Control_2	The intervention was formulated using behavioral science approaches for promoting health savings towards the costs of maternal health care among pregnant women and their partners. The intervention consists of a basic mobile money health savings account offered by clinicPesa and additional behavioral designs to encourage savings for maternal health costs. In the intervention group, participants receive the standard clinicPesa offering in addition to behavioral designs that encourage saving. The intervention group will also have fun designs that encourage savings, such as gold coin "rewards," an animated smiling baby character, and other designs to help them keep track of savings targets, such as reminder SMS messages that sound like they are from their child. In the control group, participants receive the standard clinicPesa offering (a mobile money savings account with interest and basic SMS reminders). Both groups will have access to a smartphone application that has a mobile money health savings account as offered by clinicPesa with the ability to deposit and withdraw health savings or set targets.
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	Male and Female
Key inclusion criteria	To be eligible for joining in this study, participants should have the following characteristics: 18-49 years old, between 12-32 gestational weeks (pregnant female) OR partner of someone who is (male), own a smartphone with internet connection, has a registered mobile money account, willingness to enroll in clinicPesa. Women who are between 12-32 gestational weeks inclusive can partake in the study. Men will partake in the study if their female partner is between 12-32 gestational weeks inclusive at the time of enrollment into the study.
Key exclusion criteria	Participants are ineligible if their partner is known to already be participating in the study to avoid duplicating results of savings amounts; only one member per household may participate in the study.
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Lisa Middle name Last name Hartwig
Organization	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	81-3-3812-2111
Email	lisahartwig@g.ecc.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Lisa Middle name Last name Hartwig
Organization	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	81-3-3812-2111
Homepage URL	http://www.ich.m.u-tokyo.ac.jp/en/
Email	lisahartwig@g.ecc.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo, Graduate School of Medicine, Department of Community and Global Health
Institute
Department

Funding Source
Organization	Murata Science Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	clinicPesa, Ltd Uganda
Name of secondary funder(s)	The University of Tokyo

IRB Contact (For public release)
Organization	The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel	81-3-3812-2111
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	The University of Tokyo

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 19 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	2021 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 02 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	2021 Year 12 Month 24 Day
Last modified on	2022 Year 01 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053008

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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