Clincosm LogoSign in Get a demo

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

Sponsor
University of Tartu (Other)
Overall Status
Completed
CT.gov ID
NCT01369056
Collaborator
State University of New York - Downstate Medical Center (Other), Tibotec Pharmaceutical Limited (Industry)
150
Enrollment
1
Location
2
Arms
17
Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Advanced Adherence Counseling (AdvAdh)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
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 :
Jul 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Study subjects retention in study [Data analysed at end of study (month 12)]

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Anneli Uusküla, Principal Investigator (Professor of Epidemiology, Department of Public Health), University of Tartu
    ClinicalTrials.gov Identifier:
    NCT01369056
    Other Study ID Numbers:
    • MARTH07237
    First Posted:
    Jun 8, 2011
    Last Update Posted:
    May 26, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Anneli Uusküla, Principal Investigator (Professor of Epidemiology, Department of Public Health), University of Tartu
    antiretroviral therapy, highly active
    treatment adherence
    Additional relevant MeSH terms:
    HIV Infections
    Acquired Immunodeficiency Syndrome
    Immunologic Deficiency Syndromes

    Study Results

    No Results Posted as of May 26, 2016