Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV AIDS Medication Adherence |
Behavioral: Situated Optimal Adherence Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Randomized Controlled Trial of Situated Optimal Adherence Intervention Estonia (sOAI Estonia) Among Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia |
- Antiretroviral therapy (ART) adherence (self-reported 3-day recall measure) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
- Proportion of study subjects with undetectable HIV-1 RNA count [ Time Frame: At study baseline and on months 6 and 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Situated Optimal Adherence Intervention
Situated Optimal Adherence Intervention: see 'Interventions' for more details.
|
Behavioral: 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.
|
|
No Intervention: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- pregnant
- under the influence of alcohol or (illicit)drugs
Contacts and Locations| Contact: Anneli Uusküla, MD, MSc, PhD | +3727374195 | anneli.uuskula@ut.ee |
| Contact: Kaja-Triin Laisaar, MD, MPH | +3727374201 | kaja-triin.laisaar@ut.ee |
| Estonia | |
| West-Tallinn Central Hospital | Recruiting |
| Tallinn, Harju County, Estonia, 10617 | |
| Sub-Investigator: Kristi Rüütel, MD, PhD | |
| East-Viru Central Hospital | Recruiting |
| Kohtla-Järve, Ida-Viru County, Estonia, 31025 | |
| Sub-Investigator: Kaja-Triin Laisaar, MD, MPH | |
| Principal Investigator: | Anneli Uusküla, MD, MSc, PhD | University of Tartu |
More Information
Publications:
| Responsible Party: | Anneli Uusküla, Professor of Epidemiology, Department of Public Health, University of Tartu |
| ClinicalTrials.gov Identifier: | NCT01789138 History of Changes |
| Other Study ID Numbers: | SARTH12115T, 3.2.1001.11-0020 |
| Study First Received: | February 8, 2013 |
| Last Updated: | February 8, 2013 |
| Health Authority: | Estonia: Research Ethics Committee |
Keywords provided by University of Tartu:
|
Antiretroviral Therapy Adherence Intervention |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013