Randomized Controlled Trial of Situated Optimal Adherence Intervention Estonia (sOAI Estonia) Among Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Tartu
- Enrollment
- 519
- Locations
- 4
- Primary Endpoint
- Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •under the influence of alcohol or (illicit)drugs
Outcomes
Primary Outcomes
Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
Time Frame: 12 months
Secondary Outcomes
- HIV-1 RNA Count / Viral Load (VL)(12 months)
Investigators
Anneli Uusküla
Professor of Epidemiology, Department of Public Health
University of Tartu