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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

519 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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

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HIV AIDS Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Situated Optimal Adherence Intervention

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

Group Type EXPERIMENTAL

Situated Optimal Adherence Intervention

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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