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

This study has been completed.
Sponsor:
Collaborators:
State University of New York - Downstate Medical Center
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Anneli Uusküla, University of Tartu
ClinicalTrials.gov Identifier:
NCT01369056
First received: June 3, 2011
Last updated: February 8, 2013
Last verified: February 2013

June 3, 2011
February 8, 2013
July 2010
December 2011   (final data collection date for primary outcome measure)
Change in HAART adherence level (HIV RNA and CD4+ immune cell count) [ Time Frame: Data analysed at study months 6 and 12 ] [ Designated as safety issue: No ]
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 CD4+ count are compared at months 6, 12. Factors related to achieving HIV-1 RNA level of <50copies/mL and HAART adherence >95% are assessed.
Change in HAART adherence level (HIV RNA and CD4+ immune cell count) [ Time Frame: Data analysed at study months 6 and 12 ] [ Designated as safety issue: No ]
HAART adherence is monitored and change at month 6, 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 month 6,12, and changes from the original log10 HIV-1 RNA level and CD4+ count are compared at month 6, 12. Factors related to achieving HIV-1 RNA level of <50copies/mL and HAART adherence >95% are assessed.
Complete list of historical versions of study NCT01369056 on ClinicalTrials.gov Archive Site
  • Study subjects retention in study [ Time Frame: Data analysed at end of study (month 12) ] [ Designated as safety issue: No ]
  • Change in quality of life of study subjects [ Time Frame: Data alalysed at study months 6 and 12 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence
HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence

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:

  • 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Acute HIV Infection
  • Acquired Immunodeficiency Syndrome
  • Medication Adherence
Behavioral: Advanced Adherence Counseling (AdvAdh)
Advanced Adherence Counseling (AdvAdh) consists of three 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 NextStep Counseling approach. The intervention targets: 1) accurate information about antiretroviral treatment (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 and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenges contexts.
Other Name: Situated Optimal Adherence Estonia (sOAI Estonia)
  • Experimental: Advanced Adherence Counseling (AdvAdh)
    Please see the Intervention Description section
    Intervention: Behavioral: Advanced Adherence Counseling (AdvAdh)
  • No Intervention: Control
    Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2011
December 2011   (final data collection date for primary outcome measure)

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 IAS-USA interpretive guidelines for genotypic resistance mutations

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Estonia
 
NCT01369056
MARTH07237
No
Anneli Uusküla, University of Tartu
University of Tartu
  • State University of New York - Downstate Medical Center
  • Tibotec Pharmaceutical Limited
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
University of Tartu
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP