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

University of Tartu

Status: Completed

Conditions: AIDS; Medication Adherence; HIV

Treatments: Behavioral: Situated Optimal Adherence Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01789138

3.2.1001.11-0020 (Other Grant/Funding Number)

SARTH12115T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 519 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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519 participants in 2 patient groups

Situated Optimal Adherence Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Situated Optimal Adherence Intervention

Adherence counseling, standard of care

No Intervention group

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.