Regional Differences in Human Immunodeficiency Virus (HIV) Testing

HIV Seropositivity Clinical Trial

— HIVRegional  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158987
• Other study ID #: ZKS00
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: May 2017
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 999
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• first-time HIV seropositivity

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• CD4+ T Lymphocytopenia
• HIV Infections
• HIV Seropositivity
• Lymphopenia

Intervention

Other:
• Medical record review
Review of medical records of patients diagnosed for the first time as HIV seropositivity

Locations

Country	Name	City	State
Germany	University Hospital Jena	Jena	Thuringia

Sponsors (6)

Lead Sponsor	Collaborator
Jena University Hospital	MUC Research GmbH, Technische Universität Dresden, University of Leipzig, University of Magdeburg, University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CD4+ lymphocyte counts	Number of CD4+ lymphocytes at the time of HIV diagnosis	1 day
Secondary	Symptoms of AIDS-related diseases	Presence of AIDS-related disease symptoms at the time of first HIV seropositivity diagnosis	1 day