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Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01789138
First Posted: February 11, 2013
Last Update Posted: March 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute for Health Development, Estonia
Information provided by (Responsible Party):
Anneli Uusküla, University of Tartu
  Purpose
The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the impact of a situated treatment adherence intervention program among persons living with HIV/AIDS on antiretroviral therapy in Estonia.

Condition Intervention
HIV AIDS Medication Adherence Behavioral: Situated Optimal Adherence Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Situated Optimal Adherence Intervention Estonia (sOAI Estonia) Among Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia

Resource links provided by NLM:


Further study details as provided by Anneli Uusküla, University of Tartu:

Primary Outcome Measures:
  • Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • HIV-1 RNA Count / Viral Load (VL) [ Time Frame: 12 months ]
    Undetectable viral load: HIV-1 RNA <40 copies/mL


Enrollment: 519
Study Start Date: January 2013
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Situated Optimal Adherence Intervention
Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Behavioral: Situated Optimal Adherence Intervention
Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts.
No Intervention: Adherence counseling, standard of care
Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.

Detailed Description:

Specific antiretroviral therapy (ART) can suppress HIV replication and consequently preserve the functioning of immune system. ART is a lifelong treatment with several different concomitantly administered oral medications. According to studies, low adherence to treatment is directly related to knowledge and beliefs about ART.

Studies have shown the success of different interventions increasing adherence to ART, 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 easily incorporated into the working routine of an medical institution (clinic) with limited extra resources.

Primary locations to implement activities directed at improving treatment adherence are medical institutions, i.e. the departments of infectious diseases where persons living with HIV/AIDS receive their ART.

The aim of the study is to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving ART.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV infected
  • aware of the HIV-positive status for at least 3 months
  • ≥ 18 years of age
  • speak and read either Estonian or Russian
  • receive or start (on recruitment date) antiretroviral therapy

Exclusion Criteria:

  • pregnant
  • under the influence of alcohol or (illicit)drugs
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01789138


Locations
Estonia
West-Tallinn Central Hospital
Tallinn, Harju County, Estonia, 10617
East-Viru Central Hospital
Kohtla-Järve, Ida-Viru County, Estonia, 31025
Sponsors and Collaborators
University of Tartu
National Institute for Health Development, Estonia
Investigators
Principal Investigator: Anneli Uusküla, MD, MSc, PhD University of Tartu
  More Information

Publications:
Responsible Party: Anneli Uusküla, Professor of Epidemiology, Department of Public Health, University of Tartu
ClinicalTrials.gov Identifier: NCT01789138     History of Changes
Other Study ID Numbers: SARTH12115T
3.2.1001.11-0020 ( Other Grant/Funding Number: ERDF, Estonian Healthcare Programme, self-funding )
First Submitted: February 8, 2013
First Posted: February 11, 2013
Results First Submitted: December 31, 2015
Results First Posted: February 2, 2016
Last Update Posted: March 10, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently considering.

Keywords provided by Anneli Uusküla, University of Tartu:
Antiretroviral Therapy
Adherence
Intervention


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