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
  Purpose

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.


Condition Intervention
Acute HIV Infection
Acquired Immunodeficiency Syndrome
Medication Adherence
Behavioral: Advanced Adherence Counseling (AdvAdh)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence

Resource links provided by NLM:


Further study details as provided by University of Tartu:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advanced Adherence Counseling (AdvAdh)
Please see the Intervention Description section
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)
No Intervention: Control
Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369056

Locations
Estonia
Ida-Viru Central Hospital
Kohtla-Järve, Ida-Viru County, Estonia, 31025
Sponsors and Collaborators
University of Tartu
State University of New York - Downstate Medical Center
Tibotec Pharmaceutical Limited
Investigators
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
  More Information

Additional Information:
Publications:
Radloff L. The CES-D scale: a self-report depression scale for research in the general population. Appl Psych Meas. 1977;1:385-401

Responsible Party: Anneli Uusküla, Principal Investigator (Professor of Epidemiology, Department of Public Health), University of Tartu
ClinicalTrials.gov Identifier: NCT01369056     History of Changes
Other Study ID Numbers: MARTH07237
Study First Received: June 3, 2011
Last Updated: February 8, 2013
Health Authority: Estonia: Research Ethics Committee

Keywords provided by University of Tartu:
antiretroviral therapy, highly active
treatment adherence

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014