AIMS Study: Improving HIV Treatment Adherence

NCT01429142 | Completed

• 1 other identifier: AIMS_171002208
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 7

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• Cost-effectiveness: Costs per point increase in viral load

  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).

  Month 0-14

• Effectiveness: Viral load

  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.

  Month 4-14

Secondary Outcomes (3)

• Cost-effectiveness: Costs per point increase in adherence

  Month 0-14

• Cost-effectiveness: Costs per quality adjusted life year gained

  month 0-14

• Effectiveness: Adherence

  Month 0-4, Month 5-8, Month 9-12

Study Arms (2)

AIMS intervention

EXPERIMENTAL

see http://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-13-274

Behavioral: AIMS intervention

Treatment as usual

ACTIVE COMPARATOR

see http://www.tandfonline.com/doi/abs/10.1080/08870446.2014.1001392

Behavioral: Treatment as usual

Interventions

Treatment as usual BEHAVIORAL

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.

Treatment as usual

AIMS intervention BEHAVIORAL

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.

AIMS intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients are eligible
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Maastricht University: collaborator

Study Sites (7)

Erasmus Medical Center

Rotterdam, South Holland, 3000 CA, Netherlands

Location

Sint Lucas Andreas Ziekenhuis

Amsterdam, 1006 AE, Netherlands

Location

Slotervaartziekenhuis

Amsterdam, 1066 EC, Netherlands

Location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

Leiden Universitair MEdisch Centrum

Leidern, 2333 ZA, Netherlands

Location

Haga Ziekenhuis, location Leyweg

The Hague, 2545 CH, Netherlands

Location

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

Related Publications (3)

• Wijnen BFM, Oberje EJM, Evers SMAA, Prins JM, Nobel HE, van Nieuwkoop C, Veenstra J, Pijnappel FJ, Kroon FP, van Zonneveld L, van Hulzen AGW, van Broekhuizen M, de Bruin M. Cost-effectiveness and Cost-utility of the Adherence Improving Self-management Strategy in Human Immunodeficiency Virus Care: A Trial-based Economic Evaluation. Clin Infect Dis. 2019 Feb 1;68(4):658-667. doi: 10.1093/cid/ciy553.

  PMID: 30239629 DERIVED

• de Bruin M, Oberje EJM, Viechtbauer W, Nobel HE, Hiligsmann M, van Nieuwkoop C, Veenstra J, Pijnappel FJ, Kroon FP, van Zonneveld L, Groeneveld PHP, van Broekhuizen M, Evers SMAA, Prins JM. Effectiveness and cost-effectiveness of a nurse-delivered intervention to improve adherence to treatment for HIV: a pragmatic, multicentre, open-label, randomised clinical trial. Lancet Infect Dis. 2017 Jun;17(6):595-604. doi: 10.1016/S1473-3099(16)30534-5. Epub 2017 Mar 3.

  PMID: 28262598 DERIVED

• Oberje E, de Bruin M, Evers S, Viechtbauer W, Nobel HE, Schaalma H, McCambridge J, Gras L, Tousset E, Prins J. 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 Serv Res. 2013 Jul 17;13:274. doi: 10.1186/1472-6963-13-274.

  PMID: 24059292 DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

• Jan M Prins, PhD

  Academic Medical Center - University of Amsterdam (AMC-UVA)

  PRINCIPAL INVESTIGATOR

• Marijn de Bruin, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: September 5, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: May 1, 2015
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (7)