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

E. Oberjé; M. de Bruin; S. Evers; W. Viechtbauer; H.E. Nobel; H. Schaalma; J. McCambridge; L. Gras; E. Tousset; Jan Prins

doi:10.1186/1472-6963-13-274

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

E. Oberjé^*, M. de Bruin, S. Evers, W. Viechtbauer, H.E. Nobel, H. Schaalma, J. McCambridge, L. Gras, E. Tousset, Jan Prins

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Article number	274
Pages (from-to)	274-284
Number of pages	11
Journal	BMC Health Services Research
Volume	13
DOIs	https://doi.org/10.1186/1472-6963-13-274
Publication status	Published - 17 Jul 2013

Keywords

Adherence
AIMS
Economic evaluation
HIV
Intervention
Randomised controlled trial
ACTIVE ANTIRETROVIRAL THERAPY
VIRAL LOAD
HEALTH
HAART
IMPLEMENTATION
NONADHERENCE
REGIMENS
OUTCOMES
COHORT

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Cite this

Oberjé, E., de Bruin, M., Evers, S., Viechtbauer, W., Nobel, H. E., Schaalma, H., McCambridge, J., Gras, L., Tousset, E., & Prins, J. (2013). Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial. BMC Health Services Research, 13, 274-284. Article 274. https://doi.org/10.1186/1472-6963-13-274

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abstract = "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.",

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author = "E. Oberj{\'e} and {de Bruin}, M. and S. Evers and W. Viechtbauer and H.E. Nobel and H. Schaalma and J. McCambridge and L. Gras and E. Tousset and Jan Prins",

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Oberjé, E, de Bruin, M, Evers, S , Viechtbauer, W, Nobel, HE, Schaalma, H, McCambridge, J, Gras, L, Tousset, E & Prins, J 2013, 'Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial', BMC Health Services Research, vol. 13, 274, pp. 274-284. https://doi.org/10.1186/1472-6963-13-274

TY - JOUR

T1 - Cost-effectiveness of a nurse-based intervention (AIMS) to improve adherence among HIV-infected patients: design of a multi-centre randomised controlled trial

AU - Oberjé, E.

AU - de Bruin, M.

AU - Evers, S.

AU - Viechtbauer, W.

AU - Nobel, H.E.

AU - Schaalma, H.

AU - McCambridge, J.

AU - Gras, L.

AU - Tousset, E.

AU - Prins, Jan

PY - 2013/7/17

Y1 - 2013/7/17

N2 - 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.

AB - 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.

KW - Adherence

KW - AIMS

KW - Economic evaluation

KW - HIV

KW - Intervention

KW - Randomised controlled trial

KW - ACTIVE ANTIRETROVIRAL THERAPY

KW - VIRAL LOAD

KW - HEALTH

KW - HAART

KW - IMPLEMENTATION

KW - NONADHERENCE

KW - REGIMENS

KW - OUTCOMES

KW - COHORT

U2 - 10.1186/1472-6963-13-274

DO - 10.1186/1472-6963-13-274

M3 - Article

SN - 1472-6963

VL - 13

SP - 274

EP - 284

JO - BMC Health Services Research

JF - BMC Health Services Research

M1 - 274

ER -