Trial record 9 of 41 for:    " February 06, 2013":" March 08, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Tartu
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: NA
Last verified: February 2013
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Tartu:

Primary Outcome Measures:
  • Antiretroviral therapy (ART) adherence (self-reported 3-day recall measure) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789138

Contacts
Contact: Anneli Uusküla, MD, MSc, PhD +3727374195 anneli.uuskula@ut.ee
Contact: Kaja-Triin Laisaar, MD, MPH +3727374201 kaja-triin.laisaar@ut.ee

Locations
Estonia
West-Tallinn Central Hospital Recruiting
Tallinn, Harju County, Estonia, 10617
Sub-Investigator: Kristi Rüütel, MD, PhD         
East-Viru Central Hospital Recruiting
Kohtla-Järve, Ida-Viru County, Estonia, 31025
Sub-Investigator: Kaja-Triin Laisaar, MD, MPH         
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
Study First Received: February 8, 2013
Last Updated: February 8, 2013
Health Authority: Estonia: Research Ethics Committee

Keywords provided by University of Tartu:
Antiretroviral Therapy
Adherence
Intervention

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014