Regional Differences in Human Immunodeficiency Virus (HIV) Testing (HIVRegional)

August 30, 2021 updated by: Jena University Hospital

Regional Differences in Human Immunodeficiency Virus (HIV) Testing Procedures in Eastern German Federal States

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • University Hospital Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • first-time HIV seropositivity

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jena University Hospital

Collaborators

University of Leipzig
Technische Universität Dresden
University of Magdeburg
University of Rostock
MUC Research GmbH

Investigators

  • Study Director: Benjamin Schleenvoigt, M.D., University Hospital Jena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

January 30, 2019

Study Completion (ACTUAL)

January 30, 2019

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (ACTUAL)

May 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZKS00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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