HIV Infections#AwareHIVNCT05225493
HIV Indicator Diseases in Hospital and Primary Care
An observational study of HIV Infections and Primary Health Care, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Primary Health Care, Acquired Immunodeficiency Syndrome
- What is being tested?
- Peer to peer feedback and HIV rapid test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2020to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of an HIV indicator conditions.
Who cannot join
- Below 18 years of age
- Recent HIV test (< 12 months, except for mononucleosis-like disease and STDs)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Carlijn CCE Jordans
Rotterdam, South Holland, 3015GD
Carlijn C Jordans, PhD, +31634304279, c.jordans@erasmusmc.nl
Maartje M Wagemaker, RN, +31631145074, m.wagemaker@erasmusmc.nl
About this study
Official title: 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
- Conditions
- HIV Infections, Primary Health Care, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Viral, Herpes Zoster, Dermatitis, Seborrheic
- Being tested
- Peer to peer feedback, HIV rapid test
- Keywords
- General Practitioner, Medical Specialist, HIV indicator condition, HIV risk group, AIDS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Viral, Herpes Zoster, Dermatitis, Seborrheic, Pneumonia, Infectious Mononucleosis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer to peer feedbackBehavioural
HIV experts contact non-HIV specialised treating physicians on individual patient care to recommend HIV testing
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Peer to peer feedback; Diagnostic Test: HIV rapid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 year
The percentage of adequately HIV tested patients per HIV indicator condition and per medical specialism.
Measured: 31 year
The prevalence of HIV indicator conditions in primary care and hospitals.
Measured: 3 year
The incidence of HIV indicator conditions in primary care and hospitals.
Measured: 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.
Measured: 3 year
Acceptance of HIV testing in by patients, medical specialist and in primary care.
Assessed by questionnaire
Measured: 3 year
The costs of pro-active HIV indicator case finding and relation to the savings and QALY's gained
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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Jan 2020
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Leiden University Medical Center, Maasstadziekenhuis, Rijnstate Hospital, Medical Center Haaglanden
- Responsible party
- Principal investigator, Casper Rokx, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225493
- Sponsor's protocol ID
- MEC-2021-0277
- Acronym
- #AwareHIV
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable request
Publications
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.
PubMed 39731054
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Health Care Professionals in Hospital and Primary Care to Promote Adequate HIV Risk and Indicator Condition Driven Testing in Routine Care.
- ClinicalTrials.gov ID
- NCT05225493
- Acronym / sponsor ID
- #AwareHIV / MEC-2021-0277
- Conditions
- HIV Infections, Primary Health Care, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Viral, Herpes Zoster, Dermatitis, Seborrheic
- Keywords
- General Practitioner, Medical Specialist, HIV indicator condition, HIV risk group, AIDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- 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, Leiden University Medical Center, Maasstadziekenhuis, Rijnstate Hospital, Medical Center Haaglanden
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital | – | Behavioral: Peer to peer feedbackMedical specialists in hospitals and their patients aged 18 years and older in the participating hospitals who are diagnosed there with an HIV indicator condition. |
| Primary care | – | Behavioral: Peer to peer feedback, Diagnostic Test: HIV rapid testGeneral practitioners and their patients aged 18 years and older in the participating general practices who are diagnosed there with an HIV indicator condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of an HIV indicator conditions.
Key exclusion criteria (2 listed)
- Below 18 years of age
- Recent HIV test (< 12 months, except for mononucleosis-like disease and STDs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer to peer feedbackHIV experts contact non-HIV specialised treating physicians on individual patient care to recommend HIV testing | Behavioural | Hospital, Primary care |
| HIV rapid testFree HIV rapid tests are provided to non-HIV specialised treating physicians to use in individual patient care in patients at risk of HIV | Diagnostic test | Primary care |
Primary outcome
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
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
7 secondary outcomes
The number of positive HIV tests in relation to the total number of HIV tests for identified HIV indicator conditions.
Time frame: 3 year
The percentage of adequately HIV tested patients per HIV indicator condition and per medical specialism.
Time frame: 31 year
The prevalence of HIV indicator conditions in primary care and hospitals.
Time frame: 3 year
The incidence of HIV indicator conditions in primary care and hospitals.
Time frame: 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
Acceptance of HIV testing in by patients, medical specialist and in primary care.
Time frame: 3 year
The costs of pro-active HIV indicator case finding and relation to the savings and QALY's gained
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Derived from this study: PubMed 39731054Jordans 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.
- Individual participant dataSharing planned: Undecided. Available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Primary Health Care, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Casper Rokx, MD PhD (+31681336328, c.rokx@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05225493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.