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Completed

NCT Number: NCT03158987

Regional Differences in Human Immunodeficiency Virus (HIV) Testing

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.

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Key information

Conditions

HIV Seropositivity Blood-Borne Infections CD4+ T Lymphocytopenia Communicable Diseases Cytopenia Genital Diseases HIV Infections Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Leukocyte Disorders Leukopenia Lymphopenia RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral T-Lymphocytopenia, Idiopathic CD4-Positive Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Jena

Jena, Thuringia, 07747, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first-time HIV seropositivity

Exclusion criteria

  • N/A

Treatment and study plan

Medical Record Review

Other

Review of medical records of patients diagnosed for the first time as HIV seropositivity

Primary outcomes

  1. 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

Secondary outcomes

  1. CD4+ lymphocyte counts

    Time frame: 1 day

    Number of CD4+ lymphocytes at the time of HIV diagnosis

  2. Symptoms of AIDS-related diseases

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HIVRegional

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2017
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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