Email updates

Keep up to date with the latest news and content from BMC Health Services Research and BioMed Central.

Open Access Study protocol

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

Edwin Oberjé1*, Marijn de Bruin1, Silvia Evers2, Wolfgang Viechtbauer3, Hans-Erik Nobel4, Herman Schaalma5, Jim McCambridge6, Luuk Gras7, Eric Tousset8 and Jan Prins4

Author Affiliations

1 Department of Communication, University of Amsterdam, Amsterdam School of Communication Research ASCoR, Kloveniersburgwal 48, 1012 CX, Amsterdam, Netherlands

2 Department of Health Services Research, Caphri, Research School on Public Health and Primary Care, Maastricht University, Maastricht, Netherlands

3 Department of Psychiatry and Psychology, Maastricht University, School for Mental Health and Neuroscience, Maastricht, Netherlands

4 Department of Internal Medicine, Division of Infectious Diseases, Center for Infection and Immunity Amsterdam, Academic Medical Center, Amsterdam, Netherlands

5 Department of Work and Social Psychology, Maastricht University, Maastricht, Netherlands

6 Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK

7 Stichting HIV Monitoring, Amsterdam, Netherlands

8 AARDEX Group Ltd., a MWV Healthcare Company, Visé, Belgium

For all author emails, please log on.

BMC Health Services Research 2013, 13:274  doi:10.1186/1472-6963-13-274

Published: 17 July 2013

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.

Trial registration

The study has been registered on clinicaltrials.gov (Identifier: NCT01429142).

Keywords:
Adherence; AIMS; Economic evaluation; HIV; Intervention; Randomised controlled trial