AIMS Study: Improving HIV Treatment Adherence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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, Wageningen University
ClinicalTrials.gov Identifier:
NCT01429142
First received: August 25, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Intervention
HIV
Behavioral: Usual care
Behavioral: AIMS counseling

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 226
Study Start Date: September 2011
Estimated Study Completion Date: January 2015
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429142

Locations
Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3000 CA
Academic Medical Center
Amsterdam, Netherlands, 1105AZ
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands, 1006 AE
Slotervaartziekenhuis
Amsterdam, Netherlands, 1066 EC
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
Investigators
Principal Investigator: Jan M Prins, PhD Academic Medical Center - University of Amsterdam (AMC-UVA)
Principal Investigator: Marijn de Bruin, PhD VU University of Amsterdam
  More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marijn de Bruin, Assistant professor, Wageningen University
ClinicalTrials.gov Identifier: NCT01429142     History of Changes
Other Study ID Numbers: AIMS_171002208
Study First Received: August 25, 2011
Last Updated: June 3, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

ClinicalTrials.gov processed this record on October 22, 2014