NCT03158987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

September 2, 2021

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

May 17, 2017

Last Update Submit

August 30, 2021

Conditions

HIV SeropositivityCD4+ T Lymphocytopenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • CD4+ lymphocyte counts

    1 day

  • Symptoms of AIDS-related diseases

    1 day

Interventions

Medical record reviewOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • first-time HIV seropositivity

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Jena

Jena, Thuringia, 07747, Germany

Location

MeSH Terms

Conditions

HIV SeropositivityT-Lymphocytopenia, Idiopathic CD4-Positive

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLymphopeniaLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Benjamin Schleenvoigt, M.D.

    University Hospital Jena

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 18, 2017

Study Start

June 1, 2017

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

September 2, 2021

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)