Theory- and evidence-based intervention to improve adherence to antiretroviral therapy among human immunodeficiency virus (HIV)-infected patients: the AIMS study

ISRCTN	ISRCTN97730834
DOI	https://doi.org/10.1186/ISRCTN97730834
Secondary identifying numbers	NTR176

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 22/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J.M. Prins
Scientific

Academic Medical Center (AMC)
Dep. Inwendige Geneeskunde; Onderafdeling Infectieziekten, Tropische geneeskunde en AIDS; F4- 217
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 5664380
Email	j.m.prins@amc.uva.nl

Study information

Study design	Randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Theory- and evidence-based intervention to improve adherence to antiretroviral therapy among human immunodeficiency virus (HIV)-infected patients: the AIMS study
Study objectives	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).
Ethics approval(s)	Ethics approval was received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2005
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Total final enrolment	133
Key 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.
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/09/2005
Date of final enrolment	01/11/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

University/education

Added as of 11/07/2008:

No information available

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

No information available

Academic Medical Centre Amsterdam (The Netherlands) - provided MEMS-caps from the HIV outpatient clinic

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results of pilot study results	01/06/2005		Yes	No
Results article	results	01/07/2010	22/10/2021	Yes	No

Editorial Notes

22/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
27/09/2017: internal review.
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.
11/07/2008: information on the sources of funding have been added.