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

• Sponsor: Jena University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03158987
• Collaborator: University of Magdeburg (Other), University of Leipzig (Other), University of Rostock (Other), Technische Universität Dresden (Other), MUC Research GmbH (Other)
• Enrollment: 999
• Location: 1
• Actual Duration (Months): 20
• Patients Per Site Per Month: 50

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Seropositivity; CD4+ T Lymphocytopenia	Other: Medical record review

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 Design

• Study Type: Observational
• Actual Enrollment: 999 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Regional Differences in Human Immunodeficiency Virus (HIV) Testing Procedures in Eastern German Federal States
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Jan 30, 2019
• Actual Study Completion Date: Jan 30, 2019

Outcome Measures

Primary Outcome Measures

1. Type of HIV-verifying medical institution [1 day]

   Medical Institution (university hospital, general practitioner, specialized medical office) which has diagnosed HIV seropositivity for the first time

Secondary Outcome Measures

1. CD4+ lymphocyte counts [1 day]

   Number of CD4+ lymphocytes at the time of HIV diagnosis

2. Symptoms of AIDS-related diseases [1 day]

   Presence of AIDS-related disease symptoms at the time of first HIV seropositivity diagnosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• first-time HIV seropositivity

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Jena	Jena	Thuringia	Germany	07747

Sponsors and Collaborators

• Jena University Hospital
• University of Magdeburg
• University of Leipzig
• University of Rostock
• Technische Universität Dresden
• MUC Research GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jena University Hospital
• ClinicalTrials.gov Identifier: NCT03158987
• Other Study ID Numbers: ZKS00
• First Posted: May 18, 2017
• Last Update Posted: Sep 2, 2021
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; HIV Seropositivity; Lymphopenia; T-Lymphocytopenia, Idiopathic CD4-Positive

Study Results

No Results Posted as of Sep 2, 2021