UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062204 |
|---|---|
| Receipt number | R000071164 |
| Scientific Title | Evaluation of a Consultation Program for HIV-Positive Outpatients by HIV Coordinator Nurses |
| Date of disclosure of the study information | 2026/07/17 |
| Last modified on | 2026/07/10 09:24:28 |
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Basic information
Public title
Evaluation of a Consultation Program for HIV-Positive Outpatients by HIV Coordinator Nurses
Acronym
Evaluation of a Consultation Program for HIV-Positive by Nurses
Scientific Title
Evaluation of a Consultation Program for HIV-Positive Outpatients by HIV Coordinator Nurses
Scientific Title:Acronym
Evaluation of a Consultation Program for HIV-Positive by Nurses
Region
| Japan |
Condition
Condition
HIV-Positive individuals
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate a consultation program for stress reduction provided by HIV coordinator nurses.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress levels will be measured using a VAS scale at points namely before the intervention, immediately after the intervention, and immediately after the second intervention (3 months later).
Key secondary outcomes
Social support and coping status will be measured before the intervention and immediately after the second intervention (3 months later), and the program's effectiveness will be assessed immediately after the second intervention (3 months later) using a self-developed scale.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Provision of a consultation program based on stress coping and crisis-avoidance problem-solving by HIV coordinator nurses.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals assessed by their primary physician as experiencing minimal physical and psychological burden related to research participation.
Key exclusion criteria
Individuals who lack the capacity to make autonomous decisions and cannot provide written informed consent.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Nakao |
Organization
Osaka Metropolitan University
Division name
Graduate School of Nursing
Zip code
545-0051
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-9020
t-nakao@omu.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Nakao |
Organization
Osaka Metropolitan University
Division name
Graduate School of Nursing
Zip code
545-0051
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-9020
Homepage URL
t-nakao@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Osaka National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee, Graduate School of Nursing, Osaka Metropolitan University
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
Tel
06-6645-3456
gr-hab-rinri@omu.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
| 2026 | Year | 07 | Month | 17 | 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
| 2026 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 07 | Month | 10 | Day |
Last modified on
| 2026 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071164
