An interventional study of Advanced Adherence Counseling (AdvAdh) in Acute HIV Infection, Acquired Immunodeficiency Syndrome and Medication Adherence, sponsored by University of Tartu. Completed at 1 site in Estonia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-26.
Sponsored by University of Tartu · Not applicable and Interventional
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.
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:
2,102 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 277 are open to participants now.
This study's enrollment of 150 is above the median of 104 across 1,593 interventional studies indexed under Acquired Immunodeficiency Syndrome.
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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
Please see the Intervention Description section
Behavioral: Advanced Adherence Counseling (AdvAdh)
Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic
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.
Also known as: Situated Optimal Adherence Estonia (sOAI Estonia)
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.
Time frame: Data analysed at study months 6 and 12
Study subjects retention in study
Time frame: 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.
Time frame: Data analysed at study months 6 and 12
Plan to share: No
The record gives a start of Jul 2010, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
University of Tartu