Clinical trial NCT05225493: HIV Indicator Diseases in Hospital and Primary Care
Official title: Supporting Health Care Professionals in Hospital and Primary Care to Promote Adequate HIV Risk and Indicator Condition Driven Testing in Routine Care.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Keywords: General Practitioner, Medical Specialist, HIV indicator condition, HIV risk group, AIDS
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Huisartspraktijk Gezondheidscentrum Mathenesserlaan
name: TU Delft department of Artificial Intelligence and MyTomorrows
name: Huisartsen Groep Rotterdam
name: AwareHIV Project Group
name: Huisartspraktijk Handellaan
name: Huisartspraktijk Leerdam
name: Huisartspraktijk Capelle ad IJssel
name: Leiden University Medical Center
name: Maasstadziekenhuis
name: Rijnstate Hospital
name: Medical Center Haaglanden
First posted: 2022-02-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 3 year
measure: 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.
timeFrame: 3 year
Secondary outcomes:
measure: The number of positive HIV tests in relation to the total number of HIV tests for identified HIV indicator conditions.
timeFrame: 3 year
measure: The percentage of adequately HIV tested patients per HIV indicator condition and per medical specialism.
timeFrame: 31 year
measure: The prevalence of HIV indicator conditions in primary care and hospitals.
timeFrame: 3 year
measure: The incidence of HIV indicator conditions in primary care and hospitals.
timeFrame: 3 year
measure: 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.
timeFrame: 3 year
measure: Acceptance of HIV testing in by patients, medical specialist and in primary care.
timeFrame: 3 year
measure: The costs of pro-active HIV indicator case finding and relation to the savings and QALY's gained
timeFrame: 3 year
Other outcomes:
measure: 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.
timeFrame: 3 year
measure: Center for Disease Control and Prevention (CDC) HIV classification of the patients with an HIV positive test.
timeFrame: 3 year
Locations:
city: Rotterdam
country: Netherlands
facility: Carlijn CCE Jordans
state: South-Holland
Study officials:
References: