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Completed

NCT Number: NCT01789138

Adherence Support Intervention for 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.

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Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West-Tallinn Central Hospital, Tallinn, Harju, Estonia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Situated Optimal Adherence Intervention

Behavioral

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.

Primary outcomes

  1. Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)

    Time frame: 12 months

Secondary outcomes

  1. HIV-1 RNA Count / Viral Load (VL)

    Time frame: 12 months

    Undetectable viral load: HIV-1 RNA <40 copies/mL

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Collaborators

  • National Institute for Health Development, Estonia

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2013
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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