HIV Indicator Diseases in Hospital and Primary Care (#AwareHIV)

January 26, 2022 updated by: Casper Rokx, Erasmus Medical Center

Supporting Health Care Professionals in Hospital and Primary Care to Promote Adequate HIV Risk and Indicator Condition Driven Testing in Routine Care.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • South-Holland
      • Rotterdam, South-Holland, Netherlands, 3015GD
        • Recruiting
        • Carlijn CCE Jordans
        • Sub-Investigator:
          • Annelies Verbon, Prof
        • Sub-Investigator:
          • David vd Vijver, PharmD PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Casper C Rokx, PhD MD
        • Sub-Investigator:
          • Bart B Rijnders, PhD MD
        • Sub-Investigator:
          • Carlijn C Jordans, PhD
        • Sub-Investigator:
          • Adam A Anas, PhD MD
        • Sub-Investigator:
          • Jeroen J van Kampen, PhD MD
        • Sub-Investigator:
          • Robert Jan Sips, PhD
        • Sub-Investigator:
          • Jet Gisolf, MD PhD
        • Sub-Investigator:
          • Femke Mollema, MD PhD
        • Sub-Investigator:
          • Rachida El Moussaoudi, MD PhD
        • Sub-Investigator:
          • Zoltan Szlavik, PhD
        • Sub-Investigator:
          • Renee Finkenflugel, Msc
        • Sub-Investigator:
          • Anna Roukens, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • Diagnosis of an HIV indicator conditions.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
HIV experts contact non-HIV specialised treating physicians on individual patient care to recommend HIV testing
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 feedback
HIV experts contact non-HIV specialised treating physicians on individual patient care to recommend HIV testing
Diagnostic test: HIV rapid 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3 year
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.
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of positive HIV tests in relation to the total number of HIV tests for identified HIV indicator conditions.
Time Frame: 3 year
3 year
The percentage of adequately HIV tested patients per HIV indicator condition and per medical specialism.
Time Frame: 31 year
31 year
The prevalence of HIV indicator conditions in primary care and hospitals.
Time Frame: 3 year
3 year
The incidence of HIV indicator conditions in primary care and hospitals.
Time Frame: 3 year
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.
Time Frame: 3 year
3 year
Acceptance of HIV testing in by patients, medical specialist and in primary care.
Time Frame: 3 year
Assessed by questionnaire
3 year
The costs of pro-active HIV indicator case finding and relation to the savings and QALY's gained
Time Frame: 3 year
Costs of the program in relation to the savings in costs and QALY's lost as a consequence of earlier HIV diagnosis with subsequent prevented HIV transmission, AIDS comorbidity and hospital admissions.
3 year

Other Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3 year
3 year
Center for Disease Control and Prevention (CDC) HIV classification of the patients with an HIV positive test.
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Leiden University Medical Center
Medical Center Haaglanden
Rijnstate Hospital
Maasstadziekenhuis
Huisartspraktijk Gezondheidscentrum Mathenesserlaan
TU Delft department of Artificial Intelligence and MyTomorrows
Huisartsen Groep Rotterdam
AwareHIV Project Group
Huisartspraktijk Handellaan
Huisartspraktijk Leerdam
Huisartspraktijk Capelle ad IJssel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2021-0277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe