AIMS Study: Improving HIV Treatment Adherence
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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 |
- 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.
| Estimated Enrollment: | 432 |
| 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) |
| 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 |
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| Contact: Jan M Prins, PhD | +31-20-5662070 | j.m.prins@amc.uva.nl |
| Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, South Holland, Netherlands, 3000 CA | |
| Contact: Ineke van der Ende, PhD, MD +31 10 7034529 m.vanderende@erasmusmc.nl | |
| Contact: Laura van Zonneveld, Nurse +31 10 7035737 l.vanzonneveld@erasmusmc.nl | |
| Sub-Investigator: Ineke van der Ende, PhD, MD | |
| Slotervaartziekenhuis | Recruiting |
| 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 | |
| Isala Klinieken | Recruiting |
| 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 |
More Information
No publications provided
| 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: | April 10, 2012 |
| Health Authority: | Netherlands: Dutch Health Care Inspectorate |
ClinicalTrials.gov processed this record on May 23, 2013