UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061905 |
|---|---|
| Receipt number | R000070837 |
| Scientific Title | Role of SPST in Improving the Social Life of People Living with HIV/AIDS |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/15 00:42:04 |
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Basic information
Public title
Role of SPST in Improving the Social Life of People Living with HIV/AIDS
Acronym
SPST for Social Life of People Living with HIV/AIDS
Scientific Title
Role of SPST in Improving the Social Life of People Living with HIV/AIDS
Scientific Title:Acronym
SPST for Social Life of People Living with HIV/AIDS
Region
| Africa |
Condition
Condition
social maladjustment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated the effectiveness of Social Problem-Solving Therapy (SPST) on the social adjustment of people living with HIV/AIDS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Social Maladjustment Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
22 participants received the SPST intervention, which consists of 12 sessions, each lasting approximately 60 minutes.
Interventions/Control_2
The other 22 participants received a placebo and were active during the intervention, which also consists of 12 sessions, each lasting approximately 60 minutes.
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
| 25 | years-old | < |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a) must be an HIV/AIDS outpatient,
b) must give consent to participate,
c) must have been socially maladjusted,
d) must have been diagnosed with HIV, and
e) must be resident in Nsukka, Enugu state, Nigeria
Key exclusion criteria
Those who did not meet up were excluded.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Moses |
| Middle name | Onyemaechi |
| Last name | Ede |
Organization
University of Nigeria
Division name
University
Zip code
410001
Address
University of Nigeria
TEL
+2347066725165
onyemaechi.moses@gmail.com
Public contact
Name of contact person
| 1st name | Moses |
| Middle name | Onyemaechi |
| Last name | Ede |
Organization
University of Nigeria
Division name
University
Zip code
410001
Address
University of Nigeria
TEL
+2347066725165
Homepage URL
onyemaechi.moses@gmail.com
Sponsor or person
Institute
University of Nigeria
Institute
Department
Personal name
Funding Source
Organization
University of Nigeria
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Nigeria
Address
University of Nigeria
Tel
+2347066725165
onyemaechi.moses@gmail.com
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 | 06 | Month | 15 | Day |
Related information
URL releasing protocol
No URL
Publication of results
Unpublished
Result
URL related to results and publications
No URL
Number of participants that the trial has enrolled
44
Results
Findings revealed that SPST significantly improved social adjustment among participants, while gender had no significant effect, and there was no interaction effect between SPST and gender.
Results date posted
| 2026 | Year | 06 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Social maladjustment
Participant flow
22 participants in the intervention group and 22 participants in the comparison group
Adverse events
No adverse effect
Outcome measures
Social maladjustment scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 17 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070837
