Regional Differences in Human Immunodeficiency Virus (HIV... | NCT03158987

Studies
Regional Differences in Human Immunodeficiency Virus (HIV) Testing

NCT03158987

Sponsor

Jena University Hospital

Status

Completed

Last Update Posted

Sep 2, 2021Actual

Enrollment

999Actual

Phase

Not provided

Conditions

HIV Seropositivity
CD4+ T Lymphocytopenia

Interventions

Medical record review

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jan 30, 2019Actual

Completion Date

Jan 30, 2019Actual

First Submitted Date

May 17, 2017

First Submission Date that Met QC Criteria

May 17, 2017

First Posted Date

May 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2021

Last Update Posted Date

Sep 2, 2021Actual

Name	Class
University of Magdeburg	OTHER
University of Leipzig	OTHER
University of Rostock	OTHER
Technische Universität Dresden

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This retrospective observational study aims at the examination of regional differences in the procedure of referral for serological HIV testing between eastern (new) and western (old) German federal states.

Detailed Description

Increasing incidence of HIV infections urges early recognition and timely introduction of therapy. Regional differences in referral approach and patient behavior are presumably associated with considerable delays in infection recognition and therapy onset. Comparison of records of new cases which were diagnosed in 2014 in several eastern federal states and a major western German city is expected to disclose whether the regionally preferred type of the primary care institution affects the time point of first diagnosis and the elapsed time since the emergence of the infection, as assessed by Cluster of Differentiation 4 positive (CD4+) lymphocyte counts and manifestation of clinical symptoms of immune deficiency.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

999Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical record review	Other	Review of medical records of patients diagnosed for the first time as HIV seropositivity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Type of HIV-verifying medical institution	Medical Institution (university hospital, general practitioner, specialized medical office) which has diagnosed HIV seropositivity for the first time	1 day

Secondary Outcomes

Measure	Description	Time Frame
CD4+ lymphocyte counts	Number of CD4+ lymphocytes at the time of HIV diagnosis	1 day
Symptoms of AIDS-related diseases	Presence of AIDS-related disease symptoms at the time of first HIV seropositivity diagnosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

first-time HIV seropositivity

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who have displayed for the first time a serological proof of HIV infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Schleenvoigt, M.D.	University Hospital Jena	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Jena		Jena	Thuringia	07747	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006679	HIV Seropositivity
D018344	T-Lymphocytopenia, Idiopathic CD4-Positive

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided