HAART Adherence Among HIV-infected Persons and the Factors Affecting Treatment Adherence

NCT01369056 | Completed

• 1 other identifier: MARTH07237
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The general objective of this study is to evaluate HAART adherence in Estonia and the factors affecting adherence; and the impact of an individual adherence enhancement counselling and treatment monitoring model (Advanced Adherence, AdvAdh), compared to the regular counselling received by HAART patients.

Conditions

Acute HIV Infection; Acquired Immunodeficiency Syndrome; Medication Adherence

Keywords

antiretroviral therapy, highly active; treatment adherence

Outcome Measures

Primary Outcomes (1)

• Change in HAART adherence level (HIV RNA and CD4 count)

  HAART adherence is monitored and change at month 6 and 12, as compared to baseline is recorded and compared between the AdvAdh intervention and the control group. For assessment of the effects regression analysis is used. Percentage of patients with HIV-1 RNA level \<50 copies/mL in the two study groups is measured at baseline and months 6, 12; and changes from the original log10 HIV-1 RNA level and cluster of differentiation four (CD4) count are compared at months 6, 12. Factors related to achieving HIV-1 RNA level of \<50 copies/mL and HAART adherence \>95% are assessed.

  Data analysed at study months 6 and 12

Secondary Outcomes (2)

• Study subjects retention in study

  Data analysed at end of study (month 12)

• Change in quality of life of study subjects

  Data analysed at study months 6 and 12

Study Arms (2)

Advanced Adherence Counseling (AdvAdh)

EXPERIMENTAL

Please see the Intervention Description section

Behavioral: Advanced Adherence Counseling (AdvAdh)

Control

NO INTERVENTION

Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic

Interventions

Advanced Adherence Counseling (AdvAdh) BEHAVIORAL

AdvAdh consists of 3 individual sessions (study months 0, 3, 6) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using Next Step Counseling (NSC) approach. The intervention targets: 1) accurate information about antiretroviral treatment (ART) (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; 2) promotion of perceived sense of ease and efficacy in working ART regimen into the context of one's daily life and present life circumstances that may challenge drug use persistence; 3) identification, refinement of skills promoting ease of adhering to one's ART regimen across the diverse and challenges contexts.

Also known as: Situated Optimal Adherence Estonia (sOAI Estonia)

Advanced Adherence Counseling (AdvAdh)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected;
• ≥18 years of age;
• speak and read either Estonian or Russian;
• receiving or starting a HAART regimen

You may not qualify if:

• \- triple class antiretroviral drug resistance, as determined from a prior resistance test performed in clinical practice, defined according to International Antiviral Society - USA (IAS-USA) interpretive guidelines for genotypic resistance mutations

Sponsors & Collaborators

• University of Tartu: lead
• State University of New York - Downstate Medical Center: collaborator
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (1)

Ida-Viru Central Hospital

Kohtla-Järve, Ida-Virumaa, 31025, Estonia

Location

Related Publications (41)

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Related Links

• Estonian Health Board. Database of infectious diseases statistics. Tallinn, Estonian Health Board, 2010. http://www.terviseamet.ee/nakkushaigused/nakkushaigustesse-haigestumine/hiv-ja-aids.html

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Behavior

Study Officials

• Anjali Sharma, MD, MSc

  State University of of New York Downstate Medical Center

  PRINCIPAL INVESTIGATOR

• Anneli Uusküla, MD, MSc, PhD

  University of Tartu Department of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Professor of Epidemiology, Department of Public Health)

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 8, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 26, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)