NCT01789138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 2, 2016

Completed
Last Updated

March 10, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

February 8, 2013

Results QC Date

December 31, 2015

Last Update Submit

February 8, 2016

Conditions

HIVAIDSMedication Adherence

Keywords

Antiretroviral TherapyAdherenceIntervention

Outcome Measures

Primary Outcomes (1)

  • Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)

    12 months

Secondary Outcomes (1)

  • HIV-1 RNA Count / Viral Load (VL)

    12 months

Study Arms (2)

Situated Optimal Adherence Intervention

EXPERIMENTAL

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

Behavioral: Situated Optimal Adherence Intervention

Adherence counseling, standard of care

NO INTERVENTION

Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.

Interventions

Situated Optimal Adherence InterventionBEHAVIORAL

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.

Situated Optimal Adherence Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnant
  • under the influence of alcohol or (illicit)drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

West-Tallinn Central Hospital

Tallinn, Harju, 10617, Estonia

Location

East-Viru Central Hospital

Kohtla-Järve, Ida-Virumaa, 31025, Estonia

Location

Related 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. doi: 10.1080/09540120050042891.

    PMID: 10928201BACKGROUND

  • 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.

    PMID: 22460228BACKGROUND

  • 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.

    PMID: 18838059BACKGROUND

  • 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.

    PMID: 16846321BACKGROUND

  • 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.

    PMID: 22533736BACKGROUND

  • 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.

    PMID: 21142588BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMedication Adherence

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Prof. Anneli Uusküla
Organization
Department of Public Health, University of Tartu, ESTONIA
anneli.uuskula@ut.ee
+372 7374195

Study Officials

  • Anneli Uusküla, MD, MSc, PhD

    University of Tartu

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology, Department of Public Health

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 11, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

March 10, 2016

Results First Posted

February 2, 2016

Record last verified: 2016-02

Locations

ES(2)