Condition category
Infections and Infestations
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

  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