HIV SeropositivityHIVRegionalNCT03158987
Regional Differences in Human Immunodeficiency Virus (HIV) Testing
An observational study of HIV Seropositivity and CD4+ T Lymphocytopenia, run by Jena University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Seropositivity, CD4+ T Lymphocytopenia
- What is being tested?
- Medical record review
- How many people
- 999 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have displayed for the first time a serological proof of HIV infection
Who may be able to join
- first-time HIV seropositivity
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Seropositivity, CD4+ T Lymphocytopenia
- Being tested
- Medical record review
- Medical subject headings
- HIV Seropositivity, T-Lymphocytopenia, Idiopathic CD4-Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical record reviewOther
Review of medical records of patients diagnosed for the first time as HIV seropositivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of HIV-verifying medical institution
Medical Institution (university hospital, general practitioner, specialized medical office) which has diagnosed HIV seropositivity for the first time
Measured: 1 day
Secondary outcomes (2)
CD4+ lymphocyte counts
Number of CD4+ lymphocytes at the time of HIV diagnosis
Measured: 1 day
Symptoms of AIDS-related diseases
Presence of AIDS-related disease symptoms at the time of first HIV seropositivity diagnosis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Jun 2017
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Magdeburg, University of Leipzig, University of Rostock, Technische Universität Dresden, MUC Research GmbH
- Responsible party
- Sponsor
- Investigators
- Benjamin Schleenvoigt, M.D., Study director, University Hospital Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158987
- Sponsor's protocol ID
- ZKS00
- Acronym
- HIVRegional
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Differences in Human Immunodeficiency Virus (HIV) Testing Procedures in Eastern German Federal States
- ClinicalTrials.gov ID
- NCT03158987
- Acronym / sponsor ID
- HIVRegional / ZKS00
- Conditions
- HIV Seropositivity, CD4+ T Lymphocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- University of Magdeburg, University of Leipzig, University of Rostock, Technische Universität Dresden, MUC Research GmbH
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have displayed for the first time a serological proof of HIV infection
Key inclusion criteria (1 listed)
- first-time HIV seropositivity
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical record reviewReview of medical records of patients diagnosed for the first time as HIV seropositivity | Other | – |
Primary outcome
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
2 secondary outcomes
CD4+ lymphocyte counts
Time frame: 1 day
Symptoms of AIDS-related diseases
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for HIV Seropositivity
Active, not recruitingPhase 2
Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
Idiopathic CD4 T Cell Lymphocytopenia
RecruitingObservational study
Thinking and Memory Problems in People With HIV
HIV Positive
Recruiting
Immuno-virological Evaluation of Persons Living With HIV (PLWH)
HIV-1-infection, HIV Seropositivity
Enrolling by invitation
A Multilevel, Multiphase Optimization Strategy for PrEP (MOST:PrEP)
HIV Seropositivity
RecruitingObservational study
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
HIV, Seroconversion, HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Schleenvoigt, M.D. study director
University Hospital Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity and CD4+ T Lymphocytopenia, run by Jena University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of HIV-verifying medical institution (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.