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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789138
• Other study ID #: SARTH12115T
• Secondary ID: 3.2.1001.11-0020
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: February 8, 2016
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• AIDS
• HIV
• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
Estonia	East-Viru Central Hospital	Kohtla-Järve	Ida-Viru County
Estonia	West-Tallinn Central Hospital	Tallinn	Harju County

Sponsors (2)

Lead Sponsor	Collaborator
University of Tartu	National Institute for Health Development, Estonia

Country where clinical trial is conducted

Estonia, 

References & Publications (6)

Chesney MA, Ickovics JR, Chambers DB, Gifford AL, Neidig J, Zwickl B, Wu AW. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: the AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committee of the Adult AIDS Clinical Trials Group (AACTG). AIDS Care. 2000 Jun;12(3):255-66. — View Citation

Fisher JD, Amico KR, Fisher WA, Harman JJ. The information-motivation-behavioral skills model of antiretroviral adherence and its applications. Curr HIV/AIDS Rep. 2008 Nov;5(4):193-203. Review. — View Citation

Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006 Jul;25(4):462-73. — View Citation

Laisaar KT, Avi R, DeHovitz J, Uusküla A. Estonia at the threshold of the fourth decade of the AIDS era in Europe. AIDS Res Hum Retroviruses. 2011 Aug;27(8):841-51. doi: 10.1089/AID.2010.0223. Epub 2011 Jan 11. — View Citation

R Amico K, McMahan V, Goicochea P, Vargas L, Marcus JL, Grant RM, Liu A. Supporting study product use and accuracy in self-report in the iPrEx study: next step counseling and neutral assessment. AIDS Behav. 2012 Jul;16(5):1243-59. doi: 10.1007/s10461-012-0182-5. — View Citation

Uusküla A, Laisaar KT, Raag M, Šmidt J, Semjonova S, Kogan J, Amico KR, Sharma A, Dehovitz J. Antiretroviral therapy (ART) adherence and correlates to nonadherence among people on ART in Estonia. AIDS Care. 2012;24(12):1470-9. doi: 10.1080/09540121.2012.672724. Epub 2012 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)		12 months	No
Secondary	HIV-1 RNA Count / Viral Load (VL)	Undetectable viral load: HIV-1 RNA <40 copies/mL	12 months	No