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Completed

NCT Number: NCT04056156

Development and Implementation of an HIV-testing Intervention for Primary Care in Belgium

An innovative HIV-testing strategy is developed based on mathematical modeling results on undiagnosed HIV and being implemented in primary care settings in Belgian's Flemish region.

The systematically developed intervention aims at increasing the number of targeted HIV tests in primary care in order to identify people with undiagnosed HIV.

The intervention tool is an HIV-screening advice targeting general practitioners (GPs), combining indicator-condition based screening and target-group based screening. A group-level training to apply this advice in routine practice is being delivered as part of the continuing medical education through GP-associations.

The intervention is implemented across Flanders adopting a modified stepped wedged design: two different intervention levels (delivering written/online information on the HIV testing advice versus information plus group-level training) are being compared with a control condition (no intervention, i.e. standard practice) based on surveillance data. A mixed-method study evaluates the intervention's effectiveness, feasibility, and acceptability.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Tropical Medicine

Antwerp, 2000, Belgium

About this study

An innovative HIV-screening strategy is developed based on mathematical modelling on undiagnosed HIV and being implemented in primary care settings in Belgian's Flemish region.

A multidisciplinary advisory board including stakeholders from the public sector, community-based organizations and primary care physicians (general practitionners; GPs) has been set up to advise on the different phases of the intervention's systematic development and implementation.

Mathematical modelling using a back-calculation approach with national HIV-surveillance data delivered estimations of undiagnosed HIV and time-distribution between HIV-acquisition and diagnosis: 2805 (confidence interval: 2478 - 3186) people living with HIV remained undiagnosed in 2015, with highest rates among non-Belgian men having sex with men, and sub-Saharan African (SSA) women followed by SSA men (Marty et al., 2017) . These results informed the intervention objectives: to increase the numbers of HIV-tests performed, of new HIV-diagnoses among the priority groups with undiagnosed HIV, and of timely HIV diagnoses in these groups to link HIV positive individuals to care.

A systematic literature review (Deblonde et al., 2018) indicated that many diagnostic opportunities were missed in primary care. Therefore, formative qualitative research was conducted with 122 purposively selected GPs to understand their perceived barriers and facilitators for HIV-testing. Based on these results, the following intervention determinants are addressed: HIV-knowledge, motivation to test and skills to proactively offer an HIV-test in a non-judgmental manner. Formative research and input from the advisory board also informed the delivery mode of the intervention.

The intervention consists of an HIV-screening advice combining indicator-condition based screening (adapted for primary care) and target-group based screening. A multidisciplinary group-level training (one evening session) to apply this advice in routine practice is being delivered as part of the continuing medical education through GP-associations.

The intervention is implemented across Flanders using a modified stepped wedged design t evaluate its effectiveness: two different intervention levels (1) delivering written/online information only on the HIV testing advice versus (2) information plus group-level training, are being compared with a control condition (standard of care or no specific intervention). regional HIV surveillance data are being used for the outcome evaluation. A mixed-method study evaluates the intervention's effectiveness, feasibility, and acceptability.

Deblonde J, Van Beckhoven D, Loos J, Boffin N, Sasse A, Nöstlinger C, Supervie V. HIV testing within general practices in Europe: a mixed-methods systematic review. BMC public health. 2018 Dec;18(1):1191.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Flemish general practitioner associated with a GP-circle (local general practitioner-umbrella organization)

Exclusion criteria

None

Treatment and study plan

HIV-screening advice

Behavioral

To increase GP's HIV-testing behavior a targeted HIV-testing advice is spread to participants through an electronic mail

HIV-testing advice plus group-level training

Behavioral

To increase specific HIV-testing behavior among GPs a targeted HIV-testing advice is spread to participants through an electronic mail and an additional face-to-face group-level training is provided.

Primary outcomes

  1. Number of HIV-diagnoses made by GPs in Flanders

    Time frame: Each participant is assessed for 24 months, data is available end 2019

    Change in the number of new HIV-diagnosis made by GPs (2016 data serve as baseline, and are compared to 2017 and 2018 data)

Secondary outcomes

  1. HIV diagnoses among groups identified to be more likely undiagnosed

    Time frame: Each participant is assessed for 24 months, data is available end 2019

    Change in the number of new HIV diagnoses made by GPs among the groups with high risk for undiagnosed HIV (2016 data serve as baseline, and are compared to 2017 and 2018 data)

  2. Distribution of new diagnoses by CD4-cell count

    Time frame: Each participant is assessed for 24 months, data is available end 2019

    Change in the number of diagnoses in early/late stage of HIV-infection

  3. Number of HIV-tests prescribed by GPs

    Time frame: Each participant is assessed for 24 months, data is available mid 2020

    Change in the number of HIV-tests performed by GPs in Flanders in 2018 (2016 data serve as baseline, and are compared to 2017 and 2018 data)

  4. Rate of new diagnoses by number of tests

    Time frame: Each participant is assessed for 24 months, data is available mid 2020

    Change in the rate of diagnoses by tests made by GPs in Flanders in 2018

  5. GP's fidelity to the HIV-testing advice assessed qualitatively by in-depth telephone interviews

    Time frame: 17 months after start intervention

    Fidelity in implementation is measured by assessing GPs' coherence of HIV-testing in routine GP care with the HIV-testing advice. This is assessed qualitatively during in-depth telephone interviews with participants, assessing if the intervention is implemented exactly as designed. This includes questions on the content of the intervention (e.g. proposed reasons for offering an HIV-test to patients), and frequency (i.e. which patients are proactively targeted for HIV-testing by the GPs).

  6. Feasibility of implementing the HIV-testing advice/group-level training in GP's routine practice measured by a self-developed questionnaire and in-depth telephone interviews.

    Time frame: 17 months after start intervention

    Feasibility of implementation is measured by assessing determinants (i.e. influencing factors) of routinely offering HIV-tests in GP practices. This is assessed with a mixed-methods approach: both by a self-developed online questionnaire for GPs (using a Likert scale from 1-10 expressing agreements to statements on feasibility indicators) and qualitatively during in-depth telephone interviews with GPs assessing their personal experiences with the HIV-testing advice.

  7. Acceptability of the HIV-testing advice/group-level training in GP's routine practice measured by a self-developed questionnaire and in-depth telephone interviews.

    Time frame: 17 months after start intervention

    Assessment of GPs' personal experiences with the implementation of the HIV-testing advice in the GPs practice and with their patients' reaction on it. This is assessed with a mixed-methods approach: both by a self-developed online questionnaire for GPs (assessing acceptability-indicators with a Likert scale from 1-10) and during in-depth telephone interviews with GPs of the HIV-testing advice in the GPs practice.

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Sciensano

Registry information

Official study title

Using Mathematical Modelling to Determine the Number and Characteristics of People Living With Undiagnosed HIV to Inform Targeted and Innovative HIV-testing

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2019
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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