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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute HIV Infection, Acquired Immunodeficiency Syndrome, Medication Adherence

Intervention / Treatment
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* Behavioral: Advanced Adherence Counseling (AdvAdh)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Adherence Counseling (AdvAdh)<br>Please see the Intervention Description section | Behavioral: Advanced Adherence Counseling (AdvAdh)<br>* 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.<br>* Other names: Situated Optimal Adherence Estonia (sOAI Estonia);|
| No Intervention: Control<br>Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Data analysed at study months 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study subjects retention in study |  | 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. | Data analysed at study months 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiretroviral therapy, highly active, treatment adherence