|- candidate number||1302|
|- NTR Number||NTR176|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||1-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||The AIMS study.|
|- Scientific Title||Theory- and evidence-based intervention to improve adherence to antiretroviral therapy among HIV-infected patients: the AIMS study.|
|- Healt Condition(s) or Problem(s) studied||Human immunodeficiency virus (HIV)|
|- Inclusion criteria||1. HIV-1 positive, using HAART.
2. Treatment experience for at least 6 months, with a maximum of 5 years;
3. Sufficient knowledge of the English or Dutch language (verbal and in writing);
4. No current psychiatric, drug or alcohol problems;
5. More or less stable housing;
6. Able to give informed consent.
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-sep-2005|
|- planned closingdate||1-sep-2009|
|- Target number of participants||200|
|- Interventions||After a baseline period of 2 months during which adherence is registered using MEMS-caps, patients are randomized to receive the AIMS-intervention or not. |
Next, the AIMS intervention starts, and after 3-4 months (depending on the standard visiting schedule of the individual patient) the intervention will end and both groups will stop using the MEMS-cap for two months.
At month 7-8, patients in both groups will use the MEMS-cap for one final follow-up period of two months.
At 0,2,5,7 and 9 months blood will be collected for intracellular HIV-RNA measurement.
Participants will complete a questionnaire at baseline, once at the end of the intervention period, and once during the follow-up.
|- Primary outcome||1. The primary purpose of the proposed study is to investigate whether or not adherence to HAART can be significantly increased by HIV-nurses using the AIM-Strategy, and whether this is sustained over time;|
2. Whether or not these improvements result in a decrease of intracellular HIV-RNA.
|- Secondary outcome||1. Furthermore, a questionnaire will be used to see which cognitive variables of the patients are related to (non)adherence and to evaluate whether or not the intervention successfully changes those cognitive variables that cause non-adherence; |
2. Finally, a process evaluation will be conducted among patients, HIV-nurses and physicians to investigate the advantages (e.g., insight in adherence, detection of treatment problems, improved communication) and disadvantages (e.g. duration intervention sessions, user-friendliness of equipment) of the use of AIMS versus providing standard care.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J.M. Prins|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.M. Prins|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Publications||De Bruin M, Hospers HJ, van den Borne HW, Kok GJ, Prins JM. Theory-
and evidence-based intervention to improve adherence to antiretroviral
therapy among HIV-infected patients in the Netherlands: a pilot study.
AIDS Patient Care STDS. 2005;19:384-94.
|- Brief summary||For an effective long-term suppression of HIV, prevention of resistance, AIDS, and AIDS-related death, high levels of adherence to the treatment are essential. Many interventions to improve adherence have been developed and investigated, but at most with moderate effects on adherence and health outcomes. Furthermore, none of these interventions used MEMS-caps (the best adherence measurement instrument currently available) to measure adherence . Therefore, we have developed a new intervention strategy: the Adherence Improving Management Strategy (AIMS or AIM-Strategy). This intervention has been developed using behavioral (change) theories and a review of previous intervention techniques that have been found effective to improve adherence. The use of MEMS-caps is a part of the intervention.
However, the intervention has yet to be investigated among a large and heterogeneous group of patients, and with both measures of adherence as well as virological outcomes (residual RNA replication). |
|- Main changes (audit trail)|
|- RECORD||26-aug-2005 - 15-dec-2006|