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

Not Applicable

Completed

• Conditions: Acute HIV Infection; Acquired Immunodeficiency Syndrome; Medication Adherence
• Interventions: Behavioral: Advanced Adherence Counseling (AdvAdh)

• Registration Number: NCT01369056
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-24
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advanced Adherence Counseling (AdvAdh)	Advanced Adherence Counseling (AdvAdh)	Please see the Intervention Description section

Primary Outcome Measures

Name	Time	Method
Change in HAART adherence level (HIV RNA and CD4 count)	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

Name	Time	Method
Study subjects retention in study	Data analysed at end of study (month 12)
Change in quality of life of study subjects	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.

Trial Locations

Locations (1)

Ida-Viru Central Hospital; 🇪🇪 Kohtla-Järve, Ida-Viru County, Estonia