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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056156
• Other study ID #: IWT 140922
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2021
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6211
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

None

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• HIV-screening advice
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
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.

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Sciensano

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Apers H, Nöstlinger C, Van Beckhoven D, Deblonde J, Apers L, Verheyen K, Loos J; HERMETIC Study Group . Identifying key elements to inform HIV-testing interventions for primary care in Belgium. Health Promot Int. 2020 Apr 1;35(2):301-311. doi: 10.1093/heapro/daz037. — View Citation

Deblonde J, Van Beckhoven D, Loos J, Boffin N, Sasse A, Nöstlinger C, Supervie V; HERMETIC Study Group. HIV testing within general practices in Europe: a mixed-methods systematic review. BMC Public Health. 2018 Oct 22;18(1):1191. doi: 10.1186/s12889-018-6107-0. Review. — View Citation

Marty L, Van Beckhoven D, Ost C et al. Unraveling the geographic and population heterogeneity of the HIV epidemic in Belgium. Poster presented at the 9th IAS Conference on HIV Science, 23-26 July 2017, Paris, France.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HIV-diagnoses made by GPs in Flanders	Change in the number of new HIV-diagnosis made by GPs (2016 data serve as baseline, and are compared to 2017 and 2018 data)	Each participant is assessed for 24 months, data is available end 2019
Secondary	HIV diagnoses among groups identified to be more likely undiagnosed	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)	Each participant is assessed for 24 months, data is available end 2019
Secondary	Distribution of new diagnoses by CD4-cell count	Change in the number of diagnoses in early/late stage of HIV-infection	Each participant is assessed for 24 months, data is available end 2019
Secondary	Number of HIV-tests prescribed by GPs	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)	Each participant is assessed for 24 months, data is available mid 2020
Secondary	Rate of new diagnoses by number of tests	Change in the rate of diagnoses by tests made by GPs in Flanders in 2018	Each participant is assessed for 24 months, data is available mid 2020
Secondary	GP's fidelity to the HIV-testing advice assessed qualitatively by in-depth telephone interviews	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).	17 months after start intervention
Secondary	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.	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.	17 months after start intervention
Secondary	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.	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.	17 months after start intervention