Clinical trial NCT04056156: Development and Implementation of an HIV-testing Intervention for Primary Care in Belgium
Official title: Using Mathematical Modelling to Determine the Number and Characteristics of People Living With Undiagnosed HIV to Inform Targeted and Innovative HIV-testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
HIV-testing
Prevention
Primary Care
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Sciensano
First posted: 2019-08-14
Enrollment: 6211
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This mixed methods study adopts a modified stepped wedged design. The classical stepped wedged cluster design involves a random and sequential crossover of clusters from control to intervention until all clusters are exposed. It includes an initial period in which no clusters are exposed to the intervention. We adopt a modified version: the two different intervention levels are added stepwise, while a control condition is retained until the end of the study period.
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

None

Primary outcomes:
measure: Number of HIV-diagnoses made by GPs in Flanders
timeFrame: Each participant is assessed for 24 months, data is available end 2019
Secondary outcomes:
measure: HIV diagnoses among groups identified to be more likely undiagnosed
timeFrame: Each participant is assessed for 24 months, data is available end 2019
measure: Distribution of new diagnoses by CD4-cell count
timeFrame: Each participant is assessed for 24 months, data is available end 2019
measure: Number of HIV-tests prescribed by GPs
timeFrame: Each participant is assessed for 24 months, data is available mid 2020
measure: Rate of new diagnoses by number of tests
timeFrame: Each participant is assessed for 24 months, data is available mid 2020
measure: GP's fidelity to the HIV-testing advice assessed qualitatively by in-depth telephone interviews
timeFrame: 17 months after start intervention
measure: 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.
timeFrame: 17 months after start intervention
measure: 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.
timeFrame: 17 months after start intervention
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Institute of Tropical Medicine
Study officials:
affiliation: Institute of Tropical Medicine
name: Christiana Noestlinger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Deblonde J, Van Beckhoven D, Loos J, Boffin N, Sasse A, Nostlinger 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.
citation: Apers H, Nostlinger 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.
citation: Apers H, Vuylsteke B, Loos J, Smekens T, Deblonde J, Van Beckhoven D, Nostlinger C. Development and Evaluation of an HIV-Testing Intervention for Primary Care: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2020 Aug 17;9(8):e16486. doi: 10.2196/16486.