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: December 31, 2015
Last verified: December 2015
Results First Received: December 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: HIV
AIDS
Medication Adherence
Intervention: Behavioral: Situated Optimal Adherence Intervention

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Situated Optimal Adherence Intervention

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

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.

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.

Participant Flow:   Overall Study
    Situated Optimal Adherence Intervention     Adherence Counseling, Standard of Care  
STARTED     254     258  
COMPLETED     213     206  
NOT COMPLETED     41     52  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Situated Optimal Adherence Intervention

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

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.

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.
Total Total of all reporting groups

Baseline Measures
    Situated Optimal Adherence Intervention     Adherence Counseling, Standard of Care     Total  
Number of Participants  
[units: participants]
  254     258     512  
Age  
[units: years]
Mean (Standard Deviation)
  34.08  (8.02)     33.92  (7.65)     34.00  (7.83)  
Gender  
[units: participants]
     
Female     113     94     207  
Male     141     164     305  
Region of Enrollment  
[units: participants]
     
Estonia     254     258     512  
Percentage of respondents with undetectable viral load [1]
[units: percentage of respondents]
  57.37     48.88     106.25  
Percentage of respondents with >= 95% ART adherence [2]
[units: percentage of respondents]
  89.62     88.32     177.94  
[1] Viral load data available for 368 of the 512 study participants: 190 in the intervention and 178 in the control arm.
[2] Patient 3-day recall measure. Data available for 426 of the study participants: 212 in the intervention and 214 in the control arm.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)   [ Time Frame: 12 months ]

2.  Secondary:   Proportion of Study Subjects With Undetectable HIV-1 RNA Count / Viral Load (VL)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Anneli Uusküla
Organization: Department of Public Health, University of Tartu, ESTONIA
phone: +372 7374195
e-mail: anneli.uuskula@ut.ee


Publications:

Responsible Party: Anneli Uusküla, University of Tartu
ClinicalTrials.gov Identifier: NCT01789138     History of Changes
Other Study ID Numbers: SARTH12115T
3.2.1001.11-0020 ( Other Grant/Funding Number: ERDF, Estonian Healthcare Programme, self-funding )
Study First Received: February 8, 2013
Results First Received: December 31, 2015
Last Updated: December 31, 2015
Health Authority: Estonia: Research Ethics Committee