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

NCT04056156 | Completed

• 1 other identifier: IWT 140922
• Study Type: interventional
• Target: 6,211
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; HIV-testing; Prevention; Primary Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• HIV diagnoses among groups identified to be more likely undiagnosed

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

• Distribution of new diagnoses by CD4-cell count

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

• Number of HIV-tests prescribed by GPs

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

• Rate of new diagnoses by number of tests

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

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

  17 months after start intervention

Study Arms (3)

Control

NO INTERVENTION

Standard of care (no specific intervention)

Level 1: Online dissemination of the HIV screening advice

EXPERIMENTAL

General practitioners included at the first level receive the HIV-testing advice through a personal electronic mail by their local GP-organization coordinator containing an information message with the printer-friendly screening advice attached. The message also provides a link to the website of the Flemish umbrella organization for GPs (https://domusmedica.be), where the tool is available for download for all Flemish GPs. A reminder is sent out to all participants after 13 months.

Behavioral: HIV-screening advice

Level 2: additional group-level training session

EXPERIMENTAL

At the second intervention level, GPs first receive intervention condition 1 and additionally the face-to-face group-level training session. These sessions are organized as part of regular 'continuous medical education' provided by the GP organizations ('quality circles') at their usual venues and are organized a few months after receiving intervention level 1. A reminder of the advice is sent out 13 months after the initiation of intervention level 1.

Behavioral: HIV-screening advice; Behavioral: HIV-testing advice plus group-level training

Interventions

HIV-screening advice BEHAVIORAL

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

Level 1: Online dissemination of the HIV screening advice; Level 2: additional group-level training session

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.

Level 2: additional group-level training session

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Sciensano: collaborator

Study Sites (1)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 30348140 BACKGROUND

• 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.

  PMID: 31056680 BACKGROUND

• 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.

  PMID: 32497016 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Christiana Noestlinger, PhD

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 14, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)