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Completed

NCT Number: NCT01369056

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

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.

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Key information

Conditions

Acute HIV Infection Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ida-Viru Central Hospital

Kohtla-Järve, Ida-Virumaa, 31025, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanced Adherence Counseling (AdvAdh)

Behavioral

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 names: Situated Optimal Adherence Estonia (sOAI Estonia)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Collaborators

  • State University of New York - Downstate Medical Center
  • Tibotec Pharmaceutical Limited

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 8, 2011
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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