Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr J.M. Prins


Contact details

Academic Medical Center (AMC)
Dep. Inwendige Geneeskunde; Onderafdeling Infectieziekten
Tropische geneeskunde en AIDS; F4- 217
P.O. Box 22660
1105 AZ
+31 (0)20 5664380

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Human immunodeficiency virus (HIV)


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



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Academic Medical Center (AMC)
1105 AZ

Sponsor information


Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
1105 AZ

Sponsor type




Funder type


Funder name

Added as of 11/07/2008:

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

University of Maastricht (The Netherlands) - provided funding for PhD student performing the study

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


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

Publication citations

  1. 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.

Additional files

Editorial Notes