UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027983 |
|---|---|
| Receipt number | R000032048 |
| Scientific Title | Highly Active Antiretroviral Therapy and Cardiovascular Risk factor profiles of HIV-infected Subjects in Nigeria: a cross-sectional study |
| Date of disclosure of the study information | 2017/07/10 |
| Last modified on | 2017/06/28 18:55:12 |
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Basic information
Public title
Highly Active Antiretroviral Therapy and Cardiovascular Risk factor profiles of HIV-infected Subjects in Nigeria: a cross-sectional study
Acronym
A risk prediction model for hypertension screening among HIV-positive Africans
Scientific Title
Highly Active Antiretroviral Therapy and Cardiovascular Risk factor profiles of HIV-infected Subjects in Nigeria: a cross-sectional study
Scientific Title:Acronym
A risk prediction model for hypertension screening among HIV-positive Africans
Region
| Africa |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare blood pressure, blood glucose, lipid profile, body mass index, waist circumference, hypertension, diabetes, obesity and metabolic syndrome between HIV patients exposed and non-exposed to antiretroviral therapy
Basic objectives2
Others
Basic objectives -Others
Measures of association between antiretroviral therapy and cardio-metabolic disorders
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Hypertension
Key secondary outcomes
Diabetes
Overweight/obesity
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HIV positive
18 years and above
Exposed to antiretroviral therapy for at least three months
Provide consent
Key exclusion criteria
HIV negative
Age below 18 years
Presence of opportunistic infections
Pregnant or lactating
Inadequate adherence to regular visits at HIV clinic
No consent provided.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr Chidozie Nduka |
Organization
Warwick Medical School, University of Warwick
Division name
Health Sciences
Zip code
Address
Gibbet Hill Road, Division of health Sciences, Warwick Medical School Building, University of Warwick, Coventry, CV4 7AL, United Kingdom
TEL
02476150711
c.nduka@warwick.ac.uk
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr Chidozie Nduka |
Organization
Warwick Medical School, University of Warwick
Division name
Health Sciences
Zip code
Address
Gibbet Hill Road, Warwick Medical School, Coventry, CV4 7AL, United Kingdom
TEL
02476150711
Homepage URL
c.nduka@warwick.ac.uk
Sponsor or person
Institute
University of Warwick
Benue State University Teaching Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Warwick
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
United Kingdom
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
REGO-2014-711
Org. issuing International ID_1
Warwick Medical School, University of Warwick
Study ID_2
NHREC/08/11/2013B
Org. issuing International ID_2
Benue State University Teaching Hospital
IND to MHLW
Institutions
Institutions
Benue State University Teaching Hospital (Makurdi, Nigeria)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was cross-sectional in nature and the sampling method was consecutive.
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032048
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
