#AwareHIV: HIV Indicator Diseases in Hospital and Primary Care

Sponsor

Erasmus Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05225493

Collaborator

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

1,500

Enrollment

Location

Anticipated Duration (Months)

28.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Primary Health Care Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases, Viral Herpes Zoster Dermatitis, Seborrheic Pneumonia Infectious Mononucleosis Psoriasis Candida Infection Lymphadenopathy Uterine Cervical Dysplasia Weight Loss Diarrhea Chronic Leukopenia Thrombocytopenia AIDS Defining Illness HIV Indicator Condition	Behavioral: Peer to peer feedback Diagnostic Test: HIV rapid test

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Acceptance of HIV testing in by patients, medical specialist and in primary care. [3 year]
Assessed by questionnaire
The costs of pro-active HIV indicator case finding and relation to the savings and QALY's gained [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.

Other Outcome Measures

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]