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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027983
Receipt No. 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

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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
Email 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
Email c.nduka@warwick.ac.uk

Sponsor
Institute University of Warwick


Benue State University Teaching Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032048

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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