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

Not Applicable

Completed

• Conditions: HIV; Medication Adherence; AIDS
• Interventions: Behavioral: Situated Optimal Adherence Intervention

• Registration Number: NCT01789138
• Lead Sponsor: University of Tartu

Brief 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Results First Submitted: 2015-12-31
• Results First Submitted QC: 2015-12-31
• Status Verified: 2016-02
• Results First Posted: 2016-02-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 519

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)	12 months

Secondary Outcome Measures

Name	Time	Method
HIV-1 RNA Count / Viral Load (VL)	12 months	Undetectable viral load: HIV-1 RNA \<40 copies/mL

Trial Locations

Locations (2)

West-Tallinn Central Hospital; 🇪🇪 Tallinn, Harju County, Estonia

East-Viru Central Hospital; 🇪🇪 Kohtla-Järve, Ida-Viru County, Estonia