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

Primary Purpose

HIV, AIDS, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
Situated Optimal Adherence Intervention
Sponsored by
University of Tartu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV focused on measuring Antiretroviral Therapy, Adherence, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West-Tallinn Central Hospital
  • East-Viru Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Situated Optimal Adherence Intervention

Adherence counseling, standard of care

Arm Description

Situated Optimal Adherence Intervention: see 'Interventions' for more details.

Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HIV-1 RNA Count / Viral Load (VL)
Undetectable viral load: HIV-1 RNA <40 copies/mL

Full Information

First Posted
February 8, 2013
Last Updated
February 8, 2016
Sponsor
University of Tartu
Collaborators
National Institute for Health Development, Estonia
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1. Study Identification

Unique Protocol Identification Number
NCT01789138
Brief Title
Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tartu
Collaborators
National Institute for Health Development, Estonia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, AIDS, Medication Adherence
Keywords
Antiretroviral Therapy, Adherence, Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
519 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Situated Optimal Adherence Intervention
Arm Type
Experimental
Arm Description
Situated Optimal Adherence Intervention: see 'Interventions' for more details.
Arm Title
Adherence counseling, standard of care
Arm Type
No Intervention
Arm Description
Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
Intervention Type
Behavioral
Intervention Name(s)
Situated Optimal Adherence Intervention
Intervention Description
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 Outcome Measure Information:
Title
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HIV-1 RNA Count / Viral Load (VL)
Description
Undetectable viral load: HIV-1 RNA <40 copies/mL
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anneli Uusküla, MD, MSc, PhD
Organizational Affiliation
University of Tartu
Official's Role
Principal Investigator
Facility Information:
Facility Name
West-Tallinn Central Hospital
City
Tallinn
State/Province
Harju County
ZIP/Postal Code
10617
Country
Estonia
Facility Name
East-Viru Central Hospital
City
Kohtla-Järve
State/Province
Ida-Viru County
ZIP/Postal Code
31025
Country
Estonia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Currently considering.
Citations:
PubMed Identifier
10928201
Citation
Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, Wu AW. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000 Jun;12(3):255-66. doi: 10.1080/09540120050042891.
Results Reference
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PubMed Identifier
22460228
Citation
R Amico K, McMahan V, Goicochea P, Vargas L, Marcus JL, Grant RM, Liu A. Supporting study product use and accuracy in self-report in the iPrEx study: next step counseling and neutral assessment. AIDS Behav. 2012 Jul;16(5):1243-59. doi: 10.1007/s10461-012-0182-5.
Results Reference
background
PubMed Identifier
18838059
Citation
Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008 Nov;5(4):193-203. doi: 10.1007/s11904-008-0028-y.
Results Reference
background
PubMed Identifier
16846321
Citation
Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006 Jul;25(4):462-73. doi: 10.1037/0278-6133.25.4.462.
Results Reference
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PubMed Identifier
22533736
Citation
Uuskula A, Laisaar KT, Raag M, Smidt J, Semjonova S, Kogan J, Amico KR, Sharma A, Dehovitz J. Antiretroviral therapy (ART) adherence and correlates to nonadherence among people on ART in Estonia. AIDS Care. 2012;24(12):1470-9. doi: 10.1080/09540121.2012.672724. Epub 2012 Apr 25.
Results Reference
background
PubMed Identifier
21142588
Citation
Laisaar KT, Avi R, DeHovitz J, Uuskula A. Estonia at the threshold of the fourth decade of the AIDS era in Europe. AIDS Res Hum Retroviruses. 2011 Aug;27(8):841-51. doi: 10.1089/aid.2010.0223. Epub 2011 Jan 11.
Results Reference
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Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia

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