Contact information
Type
Scientific
Primary contact
Dr J.M. Prins
ORCID ID
Contact details
Academic Medical Center (AMC)
Dep. Inwendige Geneeskunde; Onderafdeling Infectieziekten
Tropische geneeskunde en AIDS; F4- 217
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5664380
j.m.prins@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR176
Study information
Scientific title
Acronym
Study hypothesis
For an effective long-term suppression of HIV, prevention of resistance, Acquired Immune Deficiency Syndrome (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 behavioural (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 Ribonucleic Acid [RNA] replication).
Please note that as of 11/07/2008 information on the sources of funding have been added to this record. These changes can be seen below in the sources of funding section.
Please note that as of 14/10/2008 the anticipated end date has been changed. The initial anticipated end date of this trial was 01/09/2009; this trial has now finished recruiting and the trial was completed on 01/11/2007.
Ethics approval
Ethics approval was received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Human immunodeficiency virus (HIV)
Intervention
After a baseline period of 2 months during which adherence is registered using MEMS caps, patients are randomised to receive the AIMS-intervention or not. Once 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 and plasma HIV-RNA measurement. Participants will complete a questionnaire at baseline, once at the end of the intervention period, and once during the follow-up.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 plasma and intracellular HIV-RNA
Secondary outcome measures
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
Overall trial start date
01/09/2005
Overall trial end date
01/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. HIV-1 positive, using highly active anti-retroviral therapy (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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/09/2005
Recruitment end date
01/11/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Added as of 11/07/2008:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Maastricht (The Netherlands) - provided funding for PhD student performing the study
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academic Medical Centre Amsterdam (The Netherlands) - provided MEMS-caps from the HIV outpatient clinic
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Pilot study results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15989434
Publication citations
-
Pilot study results
de Bruin M, Hospers HJ, van den Borne HW, Kok G, 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, 6, 384-394, doi: 10.1089/apc.2005.19.384.