Clinical trial NCT01369056: HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence
Official title: HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute HIV Infection
Acquired Immunodeficiency Syndrome
Medication Adherence
Keywords: antiretroviral therapy, highly active
treatment adherence
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: State University of New York - Downstate Medical Center
name: Tibotec Pharmaceutical Limited
First posted: 2011-06-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HAART adherence level (HIV RNA and CD4 count)
timeFrame: Data analysed at study months 6 and 12
Secondary outcomes:
measure: Study subjects retention in study
timeFrame: Data analysed at end of study (month 12)
measure: Change in quality of life of study subjects
timeFrame: Data analysed at study months 6 and 12
Other outcomes:
Locations:
city: Kohtla-Järve
country: Estonia
facility: Ida-Viru Central Hospital
state: Ida-Viru County
Study officials:
affiliation: State University of of New York Downstate Medical Center
name: Anjali Sharma, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tartu Department of Public Health
name: Anneli Uusküla, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
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