Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
|ClinicalTrials.gov Identifier: NCT01789138|
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : February 2, 2016
Last Update Posted : March 10, 2016
|Condition or disease||Intervention/treatment|
|HIV AIDS Medication Adherence||Behavioral: Situated Optimal Adherence Intervention|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||519 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||January 2013|
|Primary Completion Date :||November 2014|
|Study Completion Date :||December 2014|
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.
- Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) [ Time Frame: 12 months ]
- HIV-1 RNA Count / Viral Load (VL) [ Time Frame: 12 months ]Undetectable viral load: HIV-1 RNA <40 copies/mL
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789138
|West-Tallinn Central Hospital|
|Tallinn, Harju County, Estonia, 10617|
|East-Viru Central Hospital|
|Kohtla-Järve, Ida-Viru County, Estonia, 31025|
|Principal Investigator:||Anneli Uusküla, MD, MSc, PhD||University of Tartu|