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Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial

BACKGROUND: Non-adherence to HIV-treatment can have a negative impact on patients’ treatment success rates, quality of life, infectiousness, and life expectancy. Few adherence interventions have shown positive effects on adherence and/or virologic outcomes. The theory- and evidence-based Adherence I...

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Autores principales: Oberjé, Edwin, de Bruin, Marijn, Evers, Silvia, Viechtbauer, Wolfgang, Nobel, Hans-Erik, Schaalma, Herman, McCambridge, Jim, Gras, Luuk, Tousset, Eric, Prins, Jan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3717053/
https://www.ncbi.nlm.nih.gov/pubmed/24059292
http://dx.doi.org/10.1186/1472-6963-13-274
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author Oberjé, Edwin
de Bruin, Marijn
Evers, Silvia
Viechtbauer, Wolfgang
Nobel, Hans-Erik
Schaalma, Herman
McCambridge, Jim
Gras, Luuk
Tousset, Eric
Prins, Jan
author_facet Oberjé, Edwin
de Bruin, Marijn
Evers, Silvia
Viechtbauer, Wolfgang
Nobel, Hans-Erik
Schaalma, Herman
McCambridge, Jim
Gras, Luuk
Tousset, Eric
Prins, Jan
author_sort Oberjé, Edwin
collection PubMed
description BACKGROUND: Non-adherence to HIV-treatment can have a negative impact on patients’ treatment success rates, quality of life, infectiousness, and life expectancy. Few adherence interventions have shown positive effects on adherence and/or virologic outcomes. The theory- and evidence-based Adherence Improving self-Management Strategy (AIMS) is an intervention that has been demonstrated to improve adherence and viral suppression rates in a randomised controlled trial. However, evidence of its cost-effectiveness is lacking. Following a recent review suggesting that cost-effectiveness evaluations of adherence interventions for chronic diseases are rare, and that the methodology of such evaluations is poorly described in the literature, this manuscript presents the study protocol for a multi-centre trial evaluating the effectiveness and cost-effectiveness of AIMS among a heterogeneous sample of patients. METHODS/DESIGN: The study uses a multi-centre randomised controlled trial design to compare the AIMS intervention to usual care from a societal perspective. Embedded in this RCT is a trial-based and model-based economic evaluation. A planned number of 230 HIV-infected patients are randomised to receive either AIMS or usual care. The relevant outcomes include changes in adherence, plasma viral load, quality of life, and societal costs. The time horizon for the trial-based economic evaluation is 12–15 months. Costs and effects are extrapolated to a lifetime horizon for the model-based economic evaluation. DISCUSSION: The present multicentre RCT is designed to provide sound methodological evidence regarding the effectiveness and cost-effectiveness of a nurse-based counselling intervention (AIMS) to support treatment adherence among a large and heterogeneous sample of HIV-infected patients in the Netherlands. The objective of the current paper is to describe the trial protocol in sufficient detail to allow full evaluation of the quality of the study design. It is anticipated that, if proven cost-effective, AIMS can contribute to improved evidence-based counselling guidelines for HIV-nurses and other health care professionals. TRIAL REGISTRATION: The study has been registered on clinicaltrials.gov (Identifier: NCT01429142).
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spelling pubmed-37170532013-07-21 Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial Oberjé, Edwin de Bruin, Marijn Evers, Silvia Viechtbauer, Wolfgang Nobel, Hans-Erik Schaalma, Herman McCambridge, Jim Gras, Luuk Tousset, Eric Prins, Jan BMC Health Serv Res Study Protocol BACKGROUND: Non-adherence to HIV-treatment can have a negative impact on patients’ treatment success rates, quality of life, infectiousness, and life expectancy. Few adherence interventions have shown positive effects on adherence and/or virologic outcomes. The theory- and evidence-based Adherence Improving self-Management Strategy (AIMS) is an intervention that has been demonstrated to improve adherence and viral suppression rates in a randomised controlled trial. However, evidence of its cost-effectiveness is lacking. Following a recent review suggesting that cost-effectiveness evaluations of adherence interventions for chronic diseases are rare, and that the methodology of such evaluations is poorly described in the literature, this manuscript presents the study protocol for a multi-centre trial evaluating the effectiveness and cost-effectiveness of AIMS among a heterogeneous sample of patients. METHODS/DESIGN: The study uses a multi-centre randomised controlled trial design to compare the AIMS intervention to usual care from a societal perspective. Embedded in this RCT is a trial-based and model-based economic evaluation. A planned number of 230 HIV-infected patients are randomised to receive either AIMS or usual care. The relevant outcomes include changes in adherence, plasma viral load, quality of life, and societal costs. The time horizon for the trial-based economic evaluation is 12–15 months. Costs and effects are extrapolated to a lifetime horizon for the model-based economic evaluation. DISCUSSION: The present multicentre RCT is designed to provide sound methodological evidence regarding the effectiveness and cost-effectiveness of a nurse-based counselling intervention (AIMS) to support treatment adherence among a large and heterogeneous sample of HIV-infected patients in the Netherlands. The objective of the current paper is to describe the trial protocol in sufficient detail to allow full evaluation of the quality of the study design. It is anticipated that, if proven cost-effective, AIMS can contribute to improved evidence-based counselling guidelines for HIV-nurses and other health care professionals. TRIAL REGISTRATION: The study has been registered on clinicaltrials.gov (Identifier: NCT01429142). BioMed Central 2013-07-17 /pmc/articles/PMC3717053/ /pubmed/24059292 http://dx.doi.org/10.1186/1472-6963-13-274 Text en Copyright © 2013 Oberjé et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Oberjé, Edwin
de Bruin, Marijn
Evers, Silvia
Viechtbauer, Wolfgang
Nobel, Hans-Erik
Schaalma, Herman
McCambridge, Jim
Gras, Luuk
Tousset, Eric
Prins, Jan
Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial
title Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial
title_full Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial
title_fullStr Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial
title_full_unstemmed Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial
title_short Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial
title_sort cost-effectiveness of a nurse-based intervention (aims) to improve adherence among hiv-infected patients: design of a multi-centre randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3717053/
https://www.ncbi.nlm.nih.gov/pubmed/24059292
http://dx.doi.org/10.1186/1472-6963-13-274
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