Clinical trial NCT01789138: Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Medication Adherence
Keywords: Antiretroviral Therapy
Adherence
Intervention
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: National Institute for Health Development, Estonia
First posted: 2013-02-11
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)
timeFrame: 12 months
Secondary outcomes:
measure: HIV-1 RNA Count / Viral Load (VL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: West-Tallinn Central Hospital
state: Harju County
city: Kohtla-Järve
country: Estonia
facility: East-Viru Central Hospital
state: Ida-Viru County
Study officials:
affiliation: University of Tartu
name: Anneli Uusküla, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/09540120050042891.
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.
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. doi: 10.1007/s11904-008-0028-y.
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. doi: 10.1037/0278-6133.25.4.462.
citation: Uuskula A, Laisaar KT, Raag M, Smidt 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.
citation: Laisaar KT, Avi R, DeHovitz J, Uuskula 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.