Development and Evaluation of an HIV-Testing Intervention for Primary Care: Protocol for a Mixed Methods Study

Apers, Hanne; Vuylsteke, Béa; Loos, Jasna; Smekens, Tom; Deblonde, Jessika; Beckhoven, Dominique Van; Nöstlinger, Christiana

doi:10.2196/16486

Cited by 3 publications

(1 citation statement)

References 22 publications

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“…The Swiss HCVree trial offered a theory-based intervention consisting of four e-health-assisted counselling sessions, carried out by trained nurses and supported by an e-health tool, to individuals who reported condomless sex with casual partners [42]. The design of this intervention was leveraged from a previous intervention to prevent HIV infection [43]. The structure of the behavioural intervention to be evaluated in the ICECREAM study is partially based on this e-health-assisted counselling intervention.…”

Section: Discussionmentioning

confidence: 99%

Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial

Hage

Boyd

Davidovich

et al. 2023

Preprint

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Background: As highly effective therapy against hepatitis C virus (HCV) infection is available with rapid uptake, there is newfound optimism for HCV elimination. Nevertheless, certain key populations have a high risk of HCV reinfection, in particular men who have sex with men (MSM) in Western European countries. Modelling data indicate that HCV elimination will not be feasible without reduction in risk behaviour, thus supporting the need for effective interventions aimed at reducing risk behaviour and preventing reinfections in MSM. Methods: The ICECREAM study is an international, multi-centred, phase 2, 3-arm randomised trial comparing run-in and intervention periods enrolling MSM with a history of a cured or spontaneously cleared HCV infection. Individuals are followed in routine care for six months (i.e., run-in period) and then randomly allocated (1:1:1) to one of the following: a tailored, interactive online risk-reduction behavioural intervention, a validated home-based HCV-RNA self-sampling test service using dried blood spots, or a combination of both. After randomisation, individuals are followed every 6 months until 18 months (i.e., intervention period). Interventions are delivered in addition to standard of care. Online questionnaire measuring risk behaviour over the past 6 months is administered at every visit. The primary outcome is the proportion at risk of HCV infection during run-in versus intervention periods assessed by using the HCV-MOSAIC risk score. The risk score consists of six self-reported HCV-related risk behaviours. Secondary outcomes include incidence of HCV reinfection, changes in the individual risk behaviour items and changes in sexual wellbeing since changes in sexual behaviour may have an impact on sexual experience. Two hundred forty-six MSM aged 18 years or older will be invited to participate. Discussion: The ICECREAM study is a trial aimed at establishing interventions that could effectively decrease the incidence of HCV re-infection in MSM with a previous HCV infection. By offering an online behavioural risk-reduction intervention and HCV-RNA self-sampling, both of which are aimed to influence risk behaviour, we are able to provide products to at-risk MSM that could further reduce population-level HCV incidence and ultimately help reach HCV micro-elimination. Trial registration: This study has been registered at clinicaltrials.gov identifier NCT04156945.

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Section: Discussionmentioning

confidence: 99%

Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial

Hage

Boyd

Davidovich

et al. 2023

Preprint

View full text Add to dashboard Cite

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Methodological approaches to study context in intervention implementation studies: an evidence gap map

Mielke

Brunkert

Zúñiga

et al. 2022

BMC Med Res Methodol

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Background Within implementation science studies, contextual analysis is increasingly recognized as foundational to interventions' successful and sustainable implementation. However, inconsistencies between methodological approaches currently limit progress in studying context and guidance to standardize the use of those approaches is scant. Therefore, this study's objective was to systematically review and map current methodological approaches to contextual analysis in intervention implementation studies. The results would help us both to systematize the process of contextual analysis and identify gaps in the current evidence. Methods We conducted an evidence gap map (EGM) based on literature data via a stepwise approach. First, using an empirically developed search string, we randomly sampled 20% of all intervention implementation studies available from PubMed per year (2015–2020). Second, we assessed included studies that conducted a contextual analysis. Data extraction and evaluation followed the Basel Approach for CoNtextual ANAlysis (BANANA), using a color-coded rating scheme. Also based on BANANA and on the Context and Implementation of Complex Interventions (CICI) framework–an implementation framework that pays ample attention to context– we created visual maps of various approaches to contextual analysis. Results Of 15, 286 identified intervention implementation studies and study protocols, 3017 were screened for inclusion. Of those, 110 warranted close examination, revealing 22% that reported on contextual analysis. Only one study explicitly applied a framework for contextual analysis. Data were most commonly collected via surveys (n = 15) and individual interviews (n = 13). Ten studies reported mixed-methods analyses. Twenty-two assessed meso-level contextual and setting factors, with socio-cultural aspects most commonly studied. Eighteen described the use of contextual information for subsequent project phases (e.g., intervention development/adaption, selecting implementation strategies). Nine reported contextual factors' influences on implementation and/or effectiveness outcomes. Conclusions This study describes current approaches to contextual analysis in implementation science and provides a novel framework for evaluating and mapping it. By synthesizing our findings graphically in figures, we provide an initial evidence base framework that can incorporate new findings as necessary. We strongly recommend further development of methodological approaches both to conduct contextual analysis and to systematize the reporting of it. These actions will increase the quality and consistency of implementation science research.

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Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial

Hage¹,

Boyd²,

Davidovich³

et al. 2023

Trials

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Background As highly effective therapy against hepatitis C virus (HCV) infection is available with rapid uptake, there is newfound optimism for HCV elimination. Nevertheless, certain key populations have a high risk of HCV reinfection, in particular men who have sex with men (MSM) in Western European countries. Modelling data indicate that HCV elimination will not be feasible without reduction in risk behaviour, thus supporting the need for effective interventions aimed at reducing risk behaviour and preventing reinfections in MSM. Methods The ICECREAM study is an international, multi-centred, phase 2, 3-arm randomised trial comparing run-in and intervention periods enrolling MSM with a history of a cured or spontaneously cleared HCV infection. Individuals are followed in routine care for 6 months (i.e. run-in period) and then randomly allocated (1:1:1) to one of the following: a tailored, interactive online risk-reduction behavioural intervention, a validated home-based HCV-RNA self-sampling test service using dried blood spots, or a combination of both. After randomisation, individuals are followed every 6 months until 18 months (i.e. intervention period). Interventions are delivered in addition to standard of care. Online questionnaire measuring risk behaviour over the past 6 months is administered at every visit. The primary outcome is the proportion at risk of HCV infection during run-in versus intervention periods assessed by using the HCV-MOSAIC risk score. The risk score consists of six self-reported HCV-related risk behaviours. Secondary outcomes include incidence of HCV reinfection, changes in the individual risk behaviour items and changes in sexual well-being since changes in sexual behaviour may have an impact on sexual experience. Two hundred forty-six MSM aged 18 years or older will be invited to participate. Discussion The ICECREAM study is a trial aimed at establishing interventions that could effectively decrease the incidence of HCV re-infection in MSM with a previous HCV infection. By offering an online behavioural risk-reduction intervention and HCV-RNA self-sampling, both of which are aimed to influence risk behaviour, we are able to provide products to at-risk MSM that could further reduce population-level HCV incidence and ultimately help reach HCV micro-elimination. Trial registration ClinicalTrials.gov NCT04156945. Registered on November 8, 2019

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Development and Evaluation of an HIV-Testing Intervention for Primary Care: Protocol for a Mixed Methods Study

Cited by 3 publications

References 22 publications

Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial

Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial

Methodological approaches to study context in intervention implementation studies: an evidence gap map

Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial

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