Acute HIV InfectionNCT01369056

HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence

A study testing Advanced Adherence Counseling (AdvAdh) in people with Acute HIV Infection and Acquired Immunodeficiency Syndrome, run by University of Tartu at 1 site in Estonia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The general objective of this study is to evaluate HAART adherence in Estonia and the factors affecting adherence; and the impact of an individual adherence enhancement counselling and treatment monitoring model (Advanced Adherence, AdvAdh), compared to the regular counselling received by HAART patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute HIV Infection, Acquired Immunodeficiency Syndrome, Medication Adherence
What is being tested?: Advanced Adherence Counseling (AdvAdh)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteEstonia
Study dates: Jul 2010to Dec 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV infected;
≥18 years of age;
speak and read either Estonian or Russian;
receiving or starting a HAART regimen

Who cannot join

triple class antiretroviral drug resistance, as determined from a prior resistance test performed in clinical practice, defined according to International Antiviral Society - USA (IAS-USA) interpretive guidelines for genotypic resistance mutations

Trial locations and contacts

1 site in 1 country.

Estonia1 site

Ida-Viru Central Hospital
Kohtla-Järve, Ida-Virumaa, 31025

Other trials in Estonia

About this study

Read the detailed description

Specific HIV treatment - HAART (Highly Active Antiretroviral Therapy) can suppress HIV replication and consequently preserve the functioning of immune system. HAART therapy is a lifelong treatment with several different concomitantly administered oral medications. According to studies, low adherence to treatment is directly related to patient's knowledge and beliefs about HAART.

Studies have shown the success of different interventions increasing adherence to HAART, but additional studies need to be carried out in order to determine the most effective components of the interventions and the methods most suitable considering the local context, that could be used in everyday work and with limited resources.

The first places to implement the activities directed at improving treatment adherence are medical institutions, i.e. the departments of infectious diseases where HIV-positive individuals receive HAART treatment.

The aims of the study are:

to determine the rate of adherence to HAART and its associated factors;
to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving HAART.

Conditions: Acute HIV Infection, Acquired Immunodeficiency Syndrome, Medication Adherence
Being tested: Advanced Adherence Counseling (AdvAdh)
Keywords: antiretroviral therapy, highly active, treatment adherence
Medical subject headings: Acquired Immunodeficiency Syndrome, Medication Adherence, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Advanced Adherence Counseling (AdvAdh)Behavioural
Also called Situated Optimal Adherence Estonia (sOAI Estonia)
AdvAdh consists of 3 individual sessions (study months 0, 3, 6) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using Next Step Counseling (NSC) approach. The intervention targets: 1) accurate information about antiretroviral treatment (ART) (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; 2) promotion of perceived sense of ease and efficacy in working ART regimen into the context of one's daily life and present life circumstances that may challenge drug use persistence; 3) identification, refinement of skills promoting ease of adhering to one's ART regimen across the diverse and challenges contexts.

Study groups in NCT01369056
Study group	Role	What they receive
Advanced Adherence Counseling (AdvAdh)	Experimental	Please see the Intervention Description section Receives: Behavioral: Advanced Adherence Counseling (AdvAdh)
Control	No intervention	Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HAART adherence level (HIV RNA and CD4 count)
HAART adherence is monitored and change at month 6 and 12, as compared to baseline is recorded and compared between the AdvAdh intervention and the control group. For assessment of the effects regression analysis is used. Percentage of patients with HIV-1 RNA level <50 copies/mL in the two study groups is measured at baseline and months 6, 12; and changes from the original log10 HIV-1 RNA level and cluster of differentiation four (CD4) count are compared at months 6, 12. Factors related to achieving HIV-1 RNA level of <50 copies/mL and HAART adherence >95% are assessed.
Measured: Data analysed at study months 6 and 12

Secondary outcomes (2)

Study subjects retention in study
Measured: Data analysed at end of study (month 12)
Change in quality of life of study subjects
Quality of life of study subjects (SF-10) is measured at baseline and study month 6 and 12 in both study groups. Change from baseline is calculated.
Measured: Data analysed at study months 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Dec 2011

First posted8 Jun 2011 (estimated)
Study startJul 2010
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (41)Papers the sponsor has linked to this study.
Other trials for Acute HIV InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01369056
Sponsor's protocol ID: MARTH07237
Status last verified: May 2016
First submitted: 3 Jun 2011
Last updated: 26 May 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Chesney M. Adherence to HAART regimens. AIDS Patient Care STDS. 2003 Apr;17(4):169-77. doi: 10.1089/108729103321619773.
PubMed 12737640
Lerner BH, Gulick RM, Dubler NN. Rethinking nonadherence: historical perspectives on triple-drug therapy for HIV disease. Ann Intern Med. 1998 Oct 1;129(7):573-8. doi: 10.7326/0003-4819-129-7-199810010-00012.
PubMed 9758579
Altice FL, Springer S, Buitrago M, Hunt DP, Friedland GH. Pilot study to enhance HIV care using needle exchange-based health services for out-of-treatment injecting drug users. J Urban Health. 2003 Sep;80(3):416-27. doi: 10.1093/jurban/jtg053.
PubMed 12930880
Grossberg R, Zhang Y, Gross R. A time-to-prescription-refill measure of antiretroviral adherence predicted changes in viral load in HIV. J Clin Epidemiol. 2004 Oct;57(10):1107-10. doi: 10.1016/j.jclinepi.2004.04.002.
PubMed 15528063
Radloff L. The CES-D scale: a self-report depression scale for research in the general population. Appl Psych Meas. 1977;1:385-401
Clayson DJ, Wild DJ, Quarterman P, Duprat-Lomon I, Kubin M, Coons SJ. A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials. Pharmacoeconomics. 2006;24(8):751-65. doi: 10.2165/00019053-200624080-00003.
PubMed 16898846
Simoni JM, Pearson CR, Pantalone DW, Marks G, Crepaz N. Efficacy of interventions in improving highly active antiretroviral therapy adherence and HIV-1 RNA viral load. A meta-analytic review of randomized controlled trials. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1(0 1):S23-35. doi: 10.1097/01.qai.0000248342.05438.52.
PubMed 17133201
Malta M, Magnanini MM, Strathdee SA, Bastos FI. Adherence to antiretroviral therapy among HIV-infected drug users: a meta-analysis. AIDS Behav. 2010 Aug;14(4):731-47. doi: 10.1007/s10461-008-9489-7. Epub 2008 Nov 20.
PubMed 19020970
Krusi A, Wood E, Montaner J, Kerr T. Social and structural determinants of HAART access and adherence among injection drug users. Int J Drug Policy. 2010 Jan;21(1):4-9. doi: 10.1016/j.drugpo.2009.08.003. Epub 2009 Sep 10.
PubMed 19747811
Arnsten JH, Demas PA, Farzadegan H, Grant RW, Gourevitch MN, Chang CJ, Buono D, Eckholdt H, Howard AA, Schoenbaum EE. Antiretroviral therapy adherence and viral suppression in HIV-infected drug users: comparison of self-report and electronic monitoring. Clin Infect Dis. 2001 Oct 15;33(8):1417-23. doi: 10.1086/323201. Epub 2001 Sep 5.
PubMed 11550118
Torres-Madriz G, Lerner D, Ruthazer R, Rogers WH, Wilson IB. Work-related barriers and facilitators to antiretroviral therapy adherence in persons living with HIV infection. AIDS Behav. 2011 Oct;15(7):1475-82. doi: 10.1007/s10461-010-9667-2.
PubMed 20091340
Choo PW, Rand CS, Inui TS, Lee ML, Cain E, Cordeiro-Breault M, Canning C, Platt R. Validation of patient reports, automated pharmacy records, and pill counts with electronic monitoring of adherence to antihypertensive therapy. Med Care. 1999 Sep;37(9):846-57. doi: 10.1097/00005650-199909000-00002.
PubMed 10493464
Gross R, Yip B, Lo Re V 3rd, Wood E, Alexander CS, Harrigan PR, Bangsberg DR, Montaner JS, Hogg RS. A simple, dynamic measure of antiretroviral therapy adherence predicts failure to maintain HIV-1 suppression. J Infect Dis. 2006 Oct 15;194(8):1108-14. doi: 10.1086/507680. Epub 2006 Sep 12.
PubMed 16991085
Nachega JB, Hislop M, Dowdy DW, Chaisson RE, Regensberg L, Maartens G. Adherence to nonnucleoside reverse transcriptase inhibitor-based HIV therapy and virologic outcomes. Ann Intern Med. 2007 Apr 17;146(8):564-73. doi: 10.7326/0003-4819-146-8-200704170-00007.
PubMed 17438315
Stone VE. Strategies for optimizing adherence to highly active antiretroviral therapy: lessons from research and clinical practice. Clin Infect Dis. 2001 Sep 15;33(6):865-72. doi: 10.1086/322698. Epub 2001 Aug 13.
PubMed 11512092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence
ClinicalTrials.gov ID: NCT01369056
Acronym / sponsor ID: MARTH07237
Conditions: Acute HIV Infection, Acquired Immunodeficiency Syndrome, Medication Adherence
Keywords: antiretroviral therapy, highly active, treatment adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: University of TartuUniversity, hospital or other
Collaborators: State University of New York - Downstate Medical Center, Tibotec Pharmaceutical Limited
Study start: Jul 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 8 Jun 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The aims of the study are:

to determine the rate of adherence to HAART and its associated factors;
to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving HAART.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Advanced Adherence Counseling (AdvAdh)	Experimental	Behavioral: Advanced Adherence Counseling (AdvAdh)Please see the Intervention Description section
Control	No intervention	–Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

HIV infected;
≥18 years of age;
speak and read either Estonian or Russian;
receiving or starting a HAART regimen

Key exclusion criteria (1 listed)

triple class antiretroviral drug resistance, as determined from a prior resistance test performed in clinical practice, defined according to International Antiviral Society - USA (IAS-USA) interpretive guidelines for genotypic resistance mutations

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Advanced Adherence Counseling (AdvAdh)Also: Situated Optimal Adherence Estonia (sOAI Estonia)AdvAdh consists of 3 individual sessions (study months 0, 3, 6) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using Next Step Counseling (NSC) approach. The intervention targets: 1) accurate information about antiretroviral treatment (ART) (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; 2) promotion of perceived sense of ease and efficacy in working ART regimen into the context of one's daily life and present life circumstances that may challenge drug use persistence; 3) identification, refinement of skills promoting ease of adhering to one's ART regimen across the diverse and challenges contexts.	Behavioural	Advanced Adherence Counseling (AdvAdh)

Primary outcome

Change in HAART adherence level (HIV RNA and CD4 count)
Time frame: Data analysed at study months 6 and 12
HAART adherence is monitored and change at month 6 and 12, as compared to baseline is recorded and compared between the AdvAdh intervention and the control group. For assessment of the effects regression analysis is used. Percentage of patients with HIV-1 RNA level <50 copies/mL in the two study groups is measured at baseline and months 6, 12; and changes from the original log10 HIV-1 RNA level and cluster of differentiation four (CD4) count are compared at months 6, 12. Factors related to achieving HIV-1 RNA level of <50 copies/mL and HAART adherence >95% are assessed.

2 secondary outcomes

Study subjects retention in study
Time frame: Data analysed at end of study (month 12)
Change in quality of life of study subjects
Time frame: Data analysed at study months 6 and 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
Background: PubMed 12737640Chesney M. Adherence to HAART regimens. AIDS Patient Care STDS. 2003 Apr;17(4):169-77. doi: 10.1089/108729103321619773.
Background: PubMed 9758579Lerner BH, Gulick RM, Dubler NN. Rethinking nonadherence: historical perspectives on triple-drug therapy for HIV disease. Ann Intern Med. 1998 Oct 1;129(7):573-8. doi: 10.7326/0003-4819-129-7-199810010-00012.
Background: PubMed 12930880Altice FL, Springer S, Buitrago M, Hunt DP, Friedland GH. Pilot study to enhance HIV care using needle exchange-based health services for out-of-treatment injecting drug users. J Urban Health. 2003 Sep;80(3):416-27. doi: 10.1093/jurban/jtg053.
Background: PubMed 15528063Grossberg R, Zhang Y, Gross R. A time-to-prescription-refill measure of antiretroviral adherence predicted changes in viral load in HIV. J Clin Epidemiol. 2004 Oct;57(10):1107-10. doi: 10.1016/j.jclinepi.2004.04.002.
BackgroundRadloff L. The CES-D scale: a self-report depression scale for research in the general population. Appl Psych Meas. 1977;1:385-401
Background: PubMed 16898846Clayson DJ, Wild DJ, Quarterman P, Duprat-Lomon I, Kubin M, Coons SJ. A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials. Pharmacoeconomics. 2006;24(8):751-65. doi: 10.2165/00019053-200624080-00003.
Background: PubMed 17133201Simoni JM, Pearson CR, Pantalone DW, Marks G, Crepaz N. Efficacy of interventions in improving highly active antiretroviral therapy adherence and HIV-1 RNA viral load. A meta-analytic review of randomized controlled trials. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1(0 1):S23-35. doi: 10.1097/01.qai.0000248342.05438.52.
Background: PubMed 19020970Malta M, Magnanini MM, Strathdee SA, Bastos FI. Adherence to antiretroviral therapy among HIV-infected drug users: a meta-analysis. AIDS Behav. 2010 Aug;14(4):731-47. doi: 10.1007/s10461-008-9489-7. Epub 2008 Nov 20.
Background: PubMed 19747811Krusi A, Wood E, Montaner J, Kerr T. Social and structural determinants of HAART access and adherence among injection drug users. Int J Drug Policy. 2010 Jan;21(1):4-9. doi: 10.1016/j.drugpo.2009.08.003. Epub 2009 Sep 10.
Background: PubMed 11550118Arnsten JH, Demas PA, Farzadegan H, Grant RW, Gourevitch MN, Chang CJ, Buono D, Eckholdt H, Howard AA, Schoenbaum EE. Antiretroviral therapy adherence and viral suppression in HIV-infected drug users: comparison of self-report and electronic monitoring. Clin Infect Dis. 2001 Oct 15;33(8):1417-23. doi: 10.1086/323201. Epub 2001 Sep 5.
Background: PubMed 20091340Torres-Madriz G, Lerner D, Ruthazer R, Rogers WH, Wilson IB. Work-related barriers and facilitators to antiretroviral therapy adherence in persons living with HIV infection. AIDS Behav. 2011 Oct;15(7):1475-82. doi: 10.1007/s10461-010-9667-2.
Background: PubMed 10493464Choo PW, Rand CS, Inui TS, Lee ML, Cain E, Cordeiro-Breault M, Canning C, Platt R. Validation of patient reports, automated pharmacy records, and pill counts with electronic monitoring of adherence to antihypertensive therapy. Med Care. 1999 Sep;37(9):846-57. doi: 10.1097/00005650-199909000-00002.
Estonian Health Board. Database of infectious diseases statistics. Tallinn, Estonian Health Board, 2010. http://www.terviseamet.ee/nakkushaigused/nakkushaigustesse-haigestumine/hiv-ja-aids.htmlLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anjali Sharma, MD, MSc principal investigator

State University of of New York Downstate Medical Center

Anneli Uusküla, MD, MSc, PhD principal investigator

University of Tartu Department of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Advanced Adherence Counseling (AdvAdh) in people with Acute HIV Infection and Acquired Immunodeficiency Syndrome, run by University of Tartu at 1 site in Estonia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HAART adherence level (HIV RNA and CD4 count) (time frame: Data analysed at study months 6 and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01369056, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.