AIMS Study: Improving HIV Treatment Adherence (AIMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01429142
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : November 15, 2016
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University
Information provided by (Responsible Party):
Marijn de Bruin, University of Aberdeen

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Treatment as usual Behavioral: AIMS intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: AIMS Study: Cost-effectiveness of a Nurse-based Intervention to Support HIV-treatment Adherence
Study Start Date : September 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: AIMS intervention
Behavioral: AIMS intervention

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: Treatment as usual
Behavioral: Treatment as usual
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.

Primary Outcome Measures :
  1. Cost-effectiveness: Costs per point increase in viral load [ Time Frame: Month 0-14 ]
    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).

  2. Effectiveness: Viral load [ Time Frame: Month 4-14 ]
    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.

Secondary Outcome Measures :
  1. Cost-effectiveness: Costs per point increase in adherence [ Time Frame: Month 0-14 ]
    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.

  2. Cost-effectiveness: Costs per quality adjusted life year gained [ Time Frame: month 0-14 ]
    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)

  3. Effectiveness: Adherence [ Time Frame: Month 0-4, Month 5-8, Month 9-12 ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria treatment-naive patients initiating cART:

- All patients are eligible

Inclusion criteria treatment experienced patients:

  • Started cART after 1996, and
  • Have been on cART for at least 9 months, and
  • Had at least one detectable viral load (including blips) during the last 3 years (counting of these 3 years starts after the first 9 months on cART), and
  • Had suboptimal adherence (<95% BID, <100% QD) during 2 months baseline measurement.

Exclusion criteria for treatment-naive and experienced patients:

  • Age <18 years
  • Psychiatric disorders or other comorbidities precluding compliance with study procedures
  • Pregnancy
  • Plans to interrupt treatment in the next 14 months
  • Life expectancy less than one year as determined by physician
  • Not able to communicate in English or Dutch
  • HIV resistant to three or more of the currently available antiretroviral drug classes
  • About to initiate intensive hepatitis C treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01429142

Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3000 CA
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands, 1006 AE
Amsterdam, Netherlands, 1066 EC
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
Leiden Universitair MEdisch Centrum
Leidern, Netherlands, 2333 ZA
Haga Ziekenhuis, location Leyweg
The Hague, Netherlands, 2545 CH
Isala Klinieken
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Wageningen University
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University
Principal Investigator: Jan M Prins, PhD Academic Medical Center - University of Amsterdam (AMC-UVA)
Principal Investigator: Marijn de Bruin, PhD University of Aberdeen