UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Highly Active Antiretroviral Therapy and Cardiovascular Risk factor profiles of HIV-infected Subjects in Nigeria: a cross-sectional study
Title of the study (Brief title)	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	Dr Chidozie Nduka
Organization	Warwick Medical School, University of Warwick
Division name	Health Sciences
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	Dr Chidozie Nduka
Organization	Warwick Medical School, University of Warwick
Division name	Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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