UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044232 |
|---|---|
| Receipt number | R000050335 |
| Scientific Title | A Study of Patient Reported Symptomatic Adverse Events in Patients Infected with Human Immunodeficiency Virus after Starting Antiretroviral Therapy |
| Date of disclosure of the study information | 2021/05/29 |
| Last modified on | 2025/05/21 11:21:50 |
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Basic information
Public title
A Study of Patient Reported Symptomatic Adverse Events in Patients Infected with Human Immunodeficiency Virus after Starting Antiretroviral Therapy
Acronym
PROSPECT study
Scientific Title
A Study of Patient Reported Symptomatic Adverse Events in Patients Infected with Human Immunodeficiency Virus after Starting Antiretroviral Therapy
Scientific Title:Acronym
PROSPECT study
Region
| Japan |
Condition
Condition
HIV:Human Immunodeficiency Virus
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will electronically collect symptom-related adverse events during antiretroviral therapy (ART) treatment using PRO-CTCAE, a Patient Reported Outcome (PRO).
The purpose of this study is to clarify the mode of occurrence and persistence of symptom-related adverse events in the early phase of treatment (up to 3 months).
Differences in adverse event assessment between providers and patients, and the relationship between adverse event occurrence and decision-making regarding ART treatment will be examined.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determine the incidence of symptom-related adverse events early in the course of antiretroviral therapy (ART) treatment (up to 3 months).
Key secondary outcomes
1. Changes in adverse events early in the course of treatment (up to 3 months)
2. the worst adverse event and its rate in the early phase (up to 3 months) of treatment
3. time to occurrence of certain Grade 2 and 3 or higher adverse events early in treatment (up to 3 months)
4. differences in DCS categories and regimens between groups at 1 and 3
5. comparison of CTCAEs and PRO-CTCAEs (with and without baseline subtraction) at Visit 4
6. differences in DRS between DCS categories
7. internal consistency and construct validity of the HIVTSQ (confirmatory factor analysis)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 20 years old or older
2. diagnosed with HIV infection
3. ART untreated and starting ART for the first time
Key exclusion criteria
1. Does not have a smartphone or tablet that can be used with ePRO
2. Severe mental illness
3. Cognitive impairment that may affect the completion of the questionnaire
4. Native language is not Japanese
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Sekine |
Organization
Tokyo Medical University Hospital
Division name
Department of Pharmacy
Zip code
1600023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
y-sekine@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sekine |
Organization
Tokyo Medical University Hospital
Division name
Department of Pharmacy
Zip code
1600023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
y-sekine@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant Research on Policy Planning and Evaluation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University
Tokyo University of Pharmacy and Life Sciences
Sapporo Medical University Hospital
National Center for Global Health and Medicine
National Hospital Organization Osaka National Hospital
National Hospital Organization Nagoya Medical Center
Gifu University Hospital
Chiba University Hospital
Hiroshima University Hospital
Ehime University Hospital
Sendai Medical Center
National Hospital Organization Kyushu Medical Center
Japanese Network of People living with HIV/AIDS
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Hospital
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
Sys_IRB@tokyo-med.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
| 2021 | Year | 05 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adverse events have been reported to cause discrepancies in perception between patient reports and health care providers.
HIV patients have high levels of decision-making conflict in initiating treatment.
Adverse events are thought to affect QOL, regret of decision-making, and satisfaction.
In light of the above, we will examine decision-making conflict, decision regret, QOL, CTCAEs by medical professionals, satisfaction, and patient background as relevant information for PRO-CTCAEs.
Management information
Registered date
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050335
