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

February 8, 2016 updated by: Anneli Uusküla, University of Tartu

Randomized Controlled Trial of Situated Optimal Adherence Intervention Estonia (sOAI Estonia) Among Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

519

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
    • Harju County
      • Tallinn, Harju County, Estonia, 10617
        • West-Tallinn Central Hospital
    • Ida-Viru County
      • Kohtla-Järve, Ida-Viru County, Estonia, 31025
        • East-Viru Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV-1 RNA Count / Viral Load (VL)
Time Frame: 12 months
Undetectable viral load: HIV-1 RNA <40 copies/mL
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Collaborators

National Institute for Health Development, Estonia

Investigators

  • Principal Investigator: Anneli Uusküla, MD, MSc, PhD, University of Tartu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (ESTIMATE)

February 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARTH12115T
  • 3.2.1001.11-0020 (OTHER_GRANT: ERDF, Estonian Healthcare Programme, self-funding)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Currently considering.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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