HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence
|ClinicalTrials.gov Identifier: NCT01369056|
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : May 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute HIV Infection Acquired Immunodeficiency Syndrome Medication Adherence||Behavioral: Advanced Adherence Counseling (AdvAdh)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Advanced Adherence Counseling (AdvAdh)
Please see the Intervention Description section
Behavioral: Advanced Adherence Counseling (AdvAdh)
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 Name: Situated Optimal Adherence Estonia (sOAI Estonia)
No Intervention: Control
Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic
- 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.
- Study subjects retention in study [ Time Frame: Data analysed at end of study (month 12) ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369056
|Ida-Viru Central Hospital|
|Kohtla-Järve, Ida-Viru County, Estonia, 31025|
|Principal Investigator:||Anjali Sharma, MD, MSc||State University of of New York Downstate Medical Center|
|Principal Investigator:||Anneli Uusküla, MD, MSc, PhD||University of Tartu Department of Public Health|