NCT05225493

Brief Summary

Patients are frequently evaluated by physicians for medical work-up of HIV indicator conditions in hospital and in primary care at the general practitioner. Testing for HIV is indicated with HIV indicator disorder but often omitted in clinical work-up. Besides the fact that HIV testing is forgotten, there are other reasons such as an underestimation of the risk of HIV in the event of indicator disorders, stigma and difficulties in discussing the test with a patient. Also and more relevant for primary care than for the hospital, practical challenges can exist for a patient to go to a laboratory, or costs are a hurdle. This project focuses on improving HIV indicator condition driven testing in different settings of the HIV epidemic, initially in the Netherlands as low HIV prevalence setting followed by an assessment of its benefit in different international settings. A specific focus will also be on the Rotterdam area in the Netherlands which has a high prevalence of undiagnosed HIV in the Netherlands. The ultimate aim is to decrease the number of undiagnosed HIV in populations, improve the 90-90-90 HIV cascade of care goals particularly its first pillar, and to help supporting the UNAIDS goal to end HIV/AIDS

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

4.3 years

First QC Date

January 17, 2022

Last Update Submit

January 26, 2022

Conditions

Keywords

General Practitioner, Medical Specialist, HIV indicator condition, HIV risk group, AIDS

Outcome Measures

Primary Outcomes (2)

  • The number of adequately performed HIV tests of identified HIV indicator conditions in relation to the total number of identified HIV indicator conditions by physicians in hospital settings during the project.

    3 year

  • The number of adequately performed HIV tests of identified HIV indicator conditions in relation to the total number of identified HIV indicator conditions by general practitioners in primary care during the project.

    3 year

Secondary Outcomes (7)

  • The number of positive HIV tests in relation to the total number of HIV tests for identified HIV indicator conditions.

    3 year

  • The percentage of adequately HIV tested patients per HIV indicator condition and per medical specialism.

    31 year

  • The prevalence of HIV indicator conditions in primary care and hospitals.

    3 year

  • The incidence of HIV indicator conditions in primary care and hospitals.

    3 year

  • A sensitive and specific supervised artificial Intelligence tool that recognizes risk factors for HIV and HIV indicator conditions through natural language processing (NLP) and supports the hospital and primary care in proactive HIV testing policies.

    3 year

  • +2 more secondary outcomes

Other Outcomes (2)

  • The number of HIV tests in relation to the total number of HIV tests done by gender, ethnical background, age, previous HIV test and HIV indicator conditions of the patient, primary care setting and hospital setting.

    3 year

  • Center for Disease Control and Prevention (CDC) HIV classification of the patients with an HIV positive test.

    3 year

Study Arms (2)

Hospital

Medical specialists in hospitals and their patients aged 18 years and older in the participating hospitals who are diagnosed there with an HIV indicator condition.

Behavioral: Peer to peer feedback

Primary care

General practitioners and their patients aged 18 years and older in the participating general practices who are diagnosed there with an HIV indicator condition.

Behavioral: Peer to peer feedbackDiagnostic Test: HIV rapid test

Interventions

HIV experts contact non-HIV specialised treating physicians on individual patient care to recommend HIV testing

HospitalPrimary care
HIV rapid testDIAGNOSTIC_TEST

Free HIV rapid tests are provided to non-HIV specialised treating physicians to use in individual patient care in patients at risk of HIV

Primary care

Eligibility Criteria

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

Medical specialists, general practitioners and their patients aged 18 years and older in the participating hospitals and primary care who present there with an HIV indicator condition.

You may qualify if:

  • Diagnosis of an HIV indicator conditions.

You may not qualify if:

  • Below 18 years of age
  • Recent HIV test (\< 12 months, except for mononucleosis-like disease and STDs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carlijn CCE Jordans

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Related Publications (1)

  • Jordans CCE, Niemantsverdriet-Rokx L, Struik JL, van der Waal EC, van der Voorn PVJM, Bakker N, Verbon A, Bindels PJE, Rokx C. Implementing HIV teams to improve HIV indicator condition-guided testing in general practitioner centers in the Netherlands. BMC Prim Care. 2024 Dec 27;25(1):440. doi: 10.1186/s12875-024-02666-0.

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeSexually Transmitted Diseases, ViralHerpes ZosterDermatitis, SeborrheicPneumoniaInfectious MononucleosisPsoriasisCandidiasisLymphadenopathyUterine Cervical DysplasiaWeight LossLeukopeniaThrombocytopenia

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesSkin Diseases, EczematousSkin Diseases, PapulosquamousRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesEpstein-Barr Virus InfectionsLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersMycosesBacterial Infections and MycosesPrecancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsBody Weight ChangesBody WeightSigns and SymptomsCytopeniaBlood Platelet Disorders

Central Study Contacts

Casper Rokx, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 4, 2022

Study Start

January 1, 2020

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

February 4, 2022

Record last verified: 2022-01

Locations