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| Name | Class |
|---|---|
| State University of New York - Downstate Medical Center | OTHER |
| Tibotec Pharmaceutical Limited | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Adherence Counseling (AdvAdh) | Experimental | Please see the Intervention Description section |
|
| Control | No Intervention | Standard of care (including counseling regarding antiretroviral treatment adherence) received by HIV/AIDS patients at the study clinic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Study subjects retention in study | Data analysed at end of study (month 12) | |
| 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. |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ida-Viru Central Hospital | Kohtla-Järve | Ida-Virumaa | 31025 | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12737640 | Background | Chesney M. Adherence to HAART regimens. AIDS Patient Care STDS. 2003 Apr;17(4):169-77. doi: 10.1089/108729103321619773. | |
| 9758579 | Background | Lerner BH, Gulick RM, Dubler NN. Rethinking nonadherence: historical perspectives on triple-drug therapy for HIV disease. Ann Intern Med. 1998 Oct 1;129(7):573-8. doi: 10.7326/0003-4819-129-7-199810010-00012. |
| Label | URL |
|---|---|
| Estonian Health Board. Database of infectious diseases statistics. Tallinn, Estonian Health Board, 2010. http://www.terviseamet.ee/nakkushaigused/nakkushaigustesse-haigestumine/hiv-ja-aids.html | View source |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D055118 | Medication Adherence |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Data analysed at study months 6 and 12 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D015438 | Health Behavior |
| D001519 | Behavior |