Clinical Trials Directory

Trials / Completed

CompletedNCT01789138

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

Randomized Controlled Trial of Situated Optimal Adherence Intervention Estonia (sOAI Estonia) Among Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
519 (actual)
Sponsor
University of Tartu · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSituated Optimal Adherence InterventionSituated 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.

Timeline

Start date
2013-01-01
Primary completion
2014-11-01
Completion
2014-12-01
First posted
2013-02-11
Last updated
2016-03-10
Results posted
2016-02-02

Locations

2 sites across 1 country: Estonia

Source: ClinicalTrials.gov record NCT01789138. Inclusion in this directory is not an endorsement.