HIV Indicator Diseases in Hospital and Primary Care

• Conditions: Candida Infection; Acquired Immunodeficiency Syndrome; Infectious Mononucleosis; Psoriasis; AIDS Defining Illness; Primary Health Care; Herpes Zoster; Uterine Cervical Dysplasia; Weight Loss; Leukopenia

• Registration Number: NCT05225493
• Lead Sponsor: Erasmus Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-26
• Last Update Submitted: 2022-01-26
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The number of positive HIV tests in relation to the total number of HIV tests for identified HIV indicator conditions.	3 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
Acceptance of HIV testing in by patients, medical specialist and in primary care.	3 year	Assessed by questionnaire
The percentage of adequately HIV tested patients per HIV indicator condition and per medical specialism.	31 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
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.

Trial Locations

Locations (1)

Carlijn CCE Jordans; 🇳🇱 Rotterdam, South-Holland, Netherlands