AIMS Study: Improving HIV Treatment Adherence
The objectives of the main study are to evaluate the effectiveness and the cost-effectiveness of a counseling intervention to support medication intake among patients treated for HIV. The aim is that through the availability of medication intake reports collected through electronic monitoring, more adherence problems can be identified and medical decision-making improves.
A substudy focuses on the broader range of nursing care in HIV-treatment, examining the content of care delivered to support physical, mental, sexual and social well-being; whether the delivery of the AIMS intervention affects the quality of care on domains other than adherence; and whether the content of care on these various domains can be linked to patient well-being and satisfaction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||AIMS Study: Cost-effectiveness of a Nurse-based Intervention to Support HIV-treatment Adherence|
- Cost-effectiveness: Costs per point increase in viral load [ Time Frame: Month 0-14 ] [ Designated as safety issue: No ]The costs and savings over the whole intervention period (post randomization until end of study) will be weighed against any gains observed in viral load (continuous or dichotomous: see primary effectiveness outcomes).
- Effectiveness: Viral load [ Time Frame: Month 4-14 ] [ Designated as safety issue: No ]The combined viral load at 3 pre-determined time points after the initial intervention phase will serve as the primary outcome measure. Depending on the distribution, data will be kept continuous (log transformed) or recoded to detectable versus undetectable. Planned measurements naive patients at 6-7 months, 9-10 months, and 12-14 months post-randomization. For treatment experienced patients: 4-5 months, 8-10 months, and 12-15 months after randomization.
- Cost-effectiveness: Costs per point increase in adherence [ Time Frame: Month 0-14 ] [ Designated as safety issue: No ]The costs and benefits of intervention versus control care during the study will be weighed against any improvements in adherence following the initial intervention stage. For that purpose, adherence data during follow-up (i.e. the last 4 months of the study) will be used.
- Cost-effectiveness: Costs per quality adjusted life year gained [ Time Frame: month 0-14 ] [ Designated as safety issue: No ]The costs and benefits of the intervention versus control care will be weighed against any differences observed in quality of life measured at 3 time points following the initial intervention period (time points are the same as for the primary effectiveness outcome)
- Effectiveness: Adherence [ Time Frame: Month 0-4, Month 5-8, Month 9-12 ] [ Designated as safety issue: No ]Repeated measures analyses on adherence. Time windows will show some variation due to treatment stage of patient and clinic variation, but stratification and cluster randomization should prevent unequal distribution over groups.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Experimental: Adherence counseling||
Behavioral: AIMS counseling
The AIMS-intervention is counseling intervention, using MEMS-data printed in simple plots. The following intervention steps will be followed:
-Discussion of practical, tailored information about adherence -Identification of desired adherence level and motivations -Print of patients' MEMS-report and comparison with desired level -ID causes of non-adherence and how to deal with problems -Designing a tailored action plan. -Follow-up: evaluation of accomplishments, remaining problems and solutions, until desired level of adherence has been accomplished. -Formulation of goals for behavioral maintenance.
Among patients starting treatment, the same elements will be delivered but MEMS-feedback can only be incorporated in the second session (after medication has been used). Moreover, a readiness element is added at treatment initiation, where patients discuss the necessity and concerns of initiating medication and are offered the possibility to practice intake for 2 weeks with placebo.
|Active Comparator: Usual care||
Behavioral: Usual care
In this multi-center trial, the content of usual adherence care is not known prior to the study, but it is part of our data collection to examine the content and variability between clinics and professionals afterwards.
Show Detailed Description
|Contact: Jan M Prins, PhDfirstname.lastname@example.org|
|Erasmus Medical Center||Recruiting|
|Rotterdam, South Holland, Netherlands, 3000 CA|
|Contact: Ineke van der Ende, PhD, MD +31 10 7034529 email@example.com|
|Contact: Laura van Zonneveld, Nurse +31 10 7035737 firstname.lastname@example.org|
|Sub-Investigator: Ineke van der Ende, PhD, MD|
|Amsterdam, Netherlands, 1066 EC|
|Sub-Investigator: Jan Willem Mulder, MD|
|Sint Lucas Andreas Ziekenhuis||Recruiting|
|Amsterdam, Netherlands, 1006 AE|
|Sub-Investigator: Jan Veenstra, MD|
|Academic Medical Center||Recruiting|
|Amsterdam, Netherlands, 1105AZ|
|Sub-Investigator: Jan M Prins, MD|
|Leiden Universitair MEdisch Centrum||Recruiting|
|Leidern, Netherlands, 2333 ZA|
|Sub-Investigator: Frank Kroom, MD|
|Haga Ziekenhuis, location Leyweg||Recruiting|
|The Hague, Netherlands, 2545 CH|
|Sub-Investigator: Kees van Nieuwkoop, MD|
|Zwolle, Netherlands, 8011 JW|
|Sub-Investigator: Paul Groeneveld, MD|
|Principal Investigator:||Jan M Prins, PhD||Academic Medical Center - University of Amsterdam (AMC-UVA)|
|Principal Investigator:||Marijn de Bruin, PhD||Wageningen University|