UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053332 |
|---|---|
| Receipt number | R000060875 |
| Scientific Title | Effectiveness of an intervention through mobile money shops to promote the uptake of modern contraceptives among teenagers in Uganda: A hybrid intervention study |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2026/02/03 10:55:38 |
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Basic information
Public title
Intervention study on unintended pregnancy among teenagers in Uganda
Acronym
Intervention study on unintended pregnancy among teenagers in Uganda
Scientific Title
Effectiveness of an intervention through mobile money shops to promote the uptake of modern contraceptives among teenagers in Uganda: A hybrid intervention study
Scientific Title:Acronym
Intervention study to promote modern contraceptive use among teenagers in Uganda
Region
| Africa |
Condition
Condition
Unintended Pregnancy among Teenagers
Classification by specialty
| Obstetrics and Gynecology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will test the effectiveness and applicability of a new intervention to prevent unintended pregnancies among teenagers, using mobile money shops as entry points to provide information on sexual and reproductive health and rights (SRHR) and contraceptives, as well as referrals to necessary health facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Percentage increase in modern contraceptive use among sexually active unmarried teens who do not want to become pregnant after a 4-month intervention
Key secondary outcomes
(1) Improvement in knowledge of SRHR among teenagers, (2) Improvement in awareness of SRHR among teenagers, and (3) Degree of implementation capacity of mobile money shops.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: unmarried healthy men and women, aged 15-19 years, residing in Iganga district in Uganda, who are users of the mobile money shops.
For 18-19 year olds, those with their consent, and for 15-17 year olds, those with parental/guardian's consent in addition to their own.
The selected 30 mobile money shops will provide SRHR information, contraceptives, and referrals to appropriate health facilities for teen customers. The intervention period is 4 months. During that time, the mobile money shop owners will record the number of clients and the amount of services provided. In addition, a researcher will visit the shops once a week to monitor the shop's service delivery and the reactions of the youth and community members.
Interventions/Control_2
Control group: unmarried healthy men and women, aged 15-19 years, living in Bugiri district in Uganda, who are users of the mobile money shops. The intervention period is 4 months. During this period, the selected 30 mobile money shops will not provide any services. After the Endline survey, the full set of services will be provided to the control mobile money shops.
For 18-19 years, the consent of the individual is obtained, and for 15-17 years, the consent of their parents/guardian in addition to the individual is obtained.
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
| 15 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Unmarried boys and girls aged 15-19 years old, living in Iganga and Bugiri districts in Uganda, who are healthy users of mobile money shops; for 18-19 years old, with their consent, and for 15-17 years, with the consent of their parents/guardian in addition to themselves.
Key exclusion criteria
Teens who have a plan to move outside the districts within 6 months.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Komasawa |
Organization
Nagasaki University
Division name
School of Tropical Medicine and Global Health (TMGH)
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki-city, Japan
TEL
095-819-7816
mkomasa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Komasawa |
Organization
Nagasaki University
Division name
School of Tropical Medicine and Global Health (TMGH)
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki-city, Japan
TEL
095-819-7816
Homepage URL
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000060875
mkomasa@juntendo.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Makiko Komasawa
Funding Source
Organization
Japan Society for the Promotion of Science, Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Busoga Health Forum
Name of secondary funder(s)
Japan International Cooperation Agency
IRB Contact (For public release)
Organization
JICA Ogata Sadako Research Institute for Peace and Development
Address
10-5 Ichigaya Honmuracho, Shinjuku-ku, Tokyo, Japan
Tel
+81-3-3269-2911
Suzuki.Satoko@jica.go.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
| 2024 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/14/4/e084539
Publication of results
Published
Result
URL related to results and publications
https://www.jahonline.org/article/S1054-139X(25)00322-2/fulltext
Number of participants that the trial has enrolled
1204
Results
Of the 1,204 participants, condom use significantly increased in the intervention group (adjusted odds ratio [AOR]=1.50, 95% confidence interval [CI] = 1.01-2.22), but no significant increase was observed in the control group (AOR = 1.12, 95% CI = 0.76-1.66). Furthermore, the intervention group showed improvements in knowledge regarding contraceptive methods and the fertile period. The proportion obtaining contraceptives from shops increased from 0% to 64.6% (p < .001).
Results date posted
| 2026 | Year | 01 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 13 | Day |
Baseline Characteristics
Sixty vendors participated, 30 in each arm. Of the 1,281 valid responses received at baseline, 1,204 participants (585 intervention, 619 control) were followed up at endline (77 dropouts, 95.0% retention rate). The only significant difference between the two groups was currently in education (46.3% intervention vs. 55.6% control, p = .001). Other characteristics were comparable: 52.7% were male, mean age was 17.8 years, 65.4% lived with parents, and 58.5% visited vendors more than once or once a day.
Participant flow
Of the 1,281 valid responses received at baseline, 1,204 participants (585 intervention, 619 control) were followed up at endline (77 dropouts, 95.0% retention rate). Major reasons for dropout were: inability to contact, relocation outside the city, and being a boarding student at school with no contact possible.
Adverse events
None.
Outcome measures
Primary outcome: Condom use rate during sexual intercourse over the past four months. Secondary outcomes: Knowledge about sexual and reproductive health and contraceptive intentions.
Plan to share IPD
We plan to store the anonymized individual participant data at UMIN-ICDS.
IPD sharing Plan description
We plan to store the anonymized individual participant data at UMIN-ICDS. Then, we will share them upon reasonable request.
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 20 | Day |
Other
Other related information
A manuscript on impact research has been accepted for publication in the Journal of Adolescent Health (July 25, 2025). Currently writing a manuscript from an implementation research perspective.
Management information
Registered date
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060875
