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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369056
• Other study ID #: MARTH07237
• Status: Completed
• Phase: N/A
• First received: June 3, 2011
• Last updated: May 24, 2016
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: May 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 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.

Description:

Specific HIV treatment - HAART (Highly Active Antiretroviral Therapy) can suppress HIV replication and consequently preserve the functioning of immune system. HAART therapy is a lifelong treatment with several different concomitantly administered oral medications. According to studies, low adherence to treatment is directly related to patient's knowledge and beliefs about HAART.

Studies have shown the success of different interventions increasing adherence to HAART, 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 used in everyday work and with limited resources.

The first places to implement the activities directed at improving treatment adherence are medical institutions, i.e. the departments of infectious diseases where HIV-positive individuals receive HAART treatment.

The aims of the study are:

• to determine the rate of adherence to HAART and its associated factors;

• to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving HAART.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV infected;

• =18 years of age;

• speak and read either Estonian or Russian;

• receiving or starting a HAART regimen

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Acute HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes
• Medication Adherence

Intervention

Behavioral:
• Advanced Adherence Counseling (AdvAdh)
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.

Locations

Country	Name	City	State
Estonia	Ida-Viru Central Hospital	Kohtla-Järve	Ida-Viru County

Sponsors (3)

Lead Sponsor	Collaborator
University of Tartu	State University of New York - Downstate Medical Center, Tibotec Pharmaceutical Limited

Country where clinical trial is conducted

Estonia, 

References & Publications (41)

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Platt L, Bobrova N, Rhodes T, Uusküla A, Parry JV, Rüütel K, Talu A, Abel K, Rajaleid K, Judd A. High HIV prevalence among injecting drug users in Estonia: implications for understanding the risk environment. AIDS. 2006 Oct 24;20(16):2120-3. — View Citation

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Talu A, Rajaleid K, Abel-Ollo K, Rüütel K, Rahu M, Rhodes T, Platt L, Bobrova N, Uusküla A. HIV infection and risk behaviour of primary fentanyl and amphetamine injectors in Tallinn, Estonia: implications for intervention. Int J Drug Policy. 2010 Jan;21(1):56-63. doi: 10.1016/j.drugpo.2009.02.007. Epub 2009 Apr 22. — View Citation

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Study subjects retention in study		Data analysed at end of study (month 12)	No
Secondary	Change in quality of life of study subjects	Quality of life of study subjects (SF-10) is measured at baseline and study month 6 and 12 in both study groups. Change from baseline is calculated.	Data analysed at study months 6 and 12	No

External 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