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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:
Collaborator:
National Institute for Health Development, Estonia
Information provided by (Responsible Party):
Anneli Uusküla, University of Tartu
ClinicalTrials.gov Identifier:
NCT01789138
First received: February 8, 2013
Last updated: February 8, 2016
Last verified: February 2016

February 8, 2013
February 8, 2016
January 2013
November 2014   (final data collection date for primary outcome measure)
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01789138 on ClinicalTrials.gov Archive Site
HIV-1 RNA Count / Viral Load (VL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Undetectable viral load: HIV-1 RNA <40 copies/mL
Proportion of study subjects with undetectable HIV-1 RNA count [ Time Frame: At study baseline and on months 6 and 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • HIV
  • AIDS
  • Medication Adherence
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.
  • Experimental: Situated Optimal Adherence Intervention
    Situated Optimal Adherence Intervention: see 'Interventions' for more details.
    Intervention: Behavioral: Situated Optimal Adherence Intervention
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
519
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Estonia
 
NCT01789138
SARTH12115T, 3.2.1001.11-0020
No
Undecided
Currently considering.
Anneli Uusküla, University of Tartu
University of Tartu
National Institute for Health Development, Estonia
Principal Investigator: Anneli Uusküla, MD, MSc, PhD University of Tartu
University of Tartu
February 2016

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