NCT05326061

Brief Summary

The main objective of this prospective observational cohort study is to investigate the epidemiology, the risk factors and ultimately the incidence of novel HIV infections among individuals at high risk for acquiring HIV via sex practices.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Jul 2020Dec 2030

Study Start

First participant enrolled

July 1, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

10.4 years

First QC Date

April 6, 2022

Last Update Submit

April 6, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of HIV

    Time from inclusion to HIV infection

    Up to 10 years (=Study Period)

Secondary Outcomes (1)

  • Incidence of sexually transmitted infections

    Up to 10 years (=Study Period)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting at the HIV- and/or STI ward of the Department of Dermatology at General Hospital of Vienna which are characterized as individuals at high risk for acquiring HIV will be considered as potential participants for the HIVEX registry.

You may qualify if:

  • High risk for acquiring HIV defined as followed: HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex'.
  • Age \>18 years and \<100 years.
  • Written informed consent for this registry study.

You may not qualify if:

  • \. Withdrawal of the written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted DiseasesGonorrheaChlamydia InfectionsSyphilis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialChlamydiaceae InfectionsTreponemal InfectionsSpirochaetales Infections

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.-Prof. Dr.med.univ.

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 13, 2022

Study Start

July 1, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations