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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01369056
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : May 26, 2016
State University of New York - Downstate Medical Center
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Anneli Uusküla, University of Tartu

Brief 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.

Condition or disease Intervention/treatment Phase
Acute HIV Infection Acquired Immunodeficiency Syndrome Medication Adherence Behavioral: Advanced Adherence Counseling (AdvAdh) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Advanced Adherence Counseling (AdvAdh)
Please see the Intervention Description section
Behavioral: Advanced Adherence Counseling (AdvAdh)
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.
Other Name: Situated Optimal Adherence Estonia (sOAI Estonia)

No Intervention: Control
Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Study subjects retention in study [ Time Frame: Data analysed at end of study (month 12) ]
  2. Change in quality of life of study subjects [ Time Frame: Data analysed at study months 6 and 12 ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

- 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01369056

Ida-Viru Central Hospital
Kohtla-Järve, Ida-Viru County, Estonia, 31025
Sponsors and Collaborators
University of Tartu
State University of New York - Downstate Medical Center
Tibotec Pharmaceutical Limited
Principal Investigator: Anjali Sharma, MD, MSc State University of of New York Downstate Medical Center
Principal Investigator: Anneli Uusküla, MD, MSc, PhD University of Tartu Department of Public Health

Additional Information:
Radloff L. The CES-D scale: a self-report depression scale for research in the general population. Appl Psych Meas. 1977;1:385-401
WHO/UNAIDS/UNICEF. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector: progress report, April 2007.

Responsible Party: Anneli Uusküla, Principal Investigator (Professor of Epidemiology, Department of Public Health), University of Tartu Identifier: NCT01369056     History of Changes
Other Study ID Numbers: MARTH07237
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anneli Uusküla, University of Tartu:
antiretroviral therapy, highly active
treatment adherence

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases