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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01369056
Other study ID # MARTH07237
Secondary ID
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


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)

Abel-Ollo K, Rahu M, Rajaleid K, Talu A, Ruutel K, Platt L, Bobrova N, Rhodes T, Uuskula A. Knowledge of HIV serostatus and risk behaviour among injecting drug users in Estonia. AIDS Care. 2009 Jul;21(7):851-7. doi: 10.1080/09540120802657522. — View Citation

Altice FL, Springer S, Buitrago M, Hunt DP, Friedland GH. Pilot study to enhance HIV care using needle exchange-based health services for out-of-treatment injecting drug users. J Urban Health. 2003 Sep;80(3):416-27. — View Citation

Arnsten JH, Demas PA, Farzadegan H, Grant RW, Gourevitch MN, Chang CJ, Buono D, Eckholdt H, Howard AA, Schoenbaum EE. Antiretroviral therapy adherence and viral suppression in HIV-infected drug users: comparison of self-report and electronic monitoring. Clin Infect Dis. 2001 Oct 15;33(8):1417-23. Epub 2001 Sep 5. — View Citation

Celentano DD, Vlahov D, Cohn S, Shadle VM, Obasanjo O, Moore RD. Self-reported antiretroviral therapy in injection drug users. JAMA. 1998 Aug 12;280(6):544-6. — View Citation

Charnaz, K. Constructing Grounded Theory. A Practical Guide Through Qualitative Analysis. London, Sage Publication, 2006.

Chesney M. Adherence to HAART regimens. AIDS Patient Care STDS. 2003 Apr;17(4):169-77. Review. — View Citation

Choo PW, Rand CS, Inui TS, Lee ML, Cain E, Cordeiro-Breault M, Canning C, Platt R. Validation of patient reports, automated pharmacy records, and pill counts with electronic monitoring of adherence to antihypertensive therapy. Med Care. 1999 Sep;37(9):846-57. — View Citation

Clayson DJ, Wild DJ, Quarterman P, Duprat-Lomon I, Kubin M, Coons SJ. A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials. Pharmacoeconomics. 2006;24(8):751-65. Review. — View Citation

Gross R, Yip B, Lo Re V 3rd, Wood E, Alexander CS, Harrigan PR, Bangsberg DR, Montaner JS, Hogg RS. A simple, dynamic measure of antiretroviral therapy adherence predicts failure to maintain HIV-1 suppression. J Infect Dis. 2006 Oct 15;194(8):1108-14. Epub 2006 Sep 12. — View Citation

Grossberg R, Zhang Y, Gross R. A time-to-prescription-refill measure of antiretroviral adherence predicted changes in viral load in HIV. J Clin Epidemiol. 2004 Oct;57(10):1107-10. — View Citation

Horne R, Buick D, Fisher M, Leake H, Cooper V, Weinman J. Doubts about necessity and concerns about adverse effects: identifying the types of beliefs that are associated with non-adherence to HAART. Int J STD AIDS. 2004 Jan;15(1):38-44. — View Citation

Horne R, Cooper V, Gellaitry G, Date HL, Fisher M. Patients' perceptions of highly active antiretroviral therapy in relation to treatment uptake and adherence: the utility of the necessity-concerns framework. J Acquir Immune Defic Syndr. 2007 Jul 1;45(3):334-41. — View Citation

Krüsi A, Wood E, Montaner J, Kerr T. Social and structural determinants of HAART access and adherence among injection drug users. Int J Drug Policy. 2010 Jan;21(1):4-9. doi: 10.1016/j.drugpo.2009.08.003. Epub 2009 Sep 10. — View Citation

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. Review. — View Citation

Lucas GM, Chaisson RE, Moore RD. Highly active antiretroviral therapy in a large urban clinic: risk factors for virologic failure and adverse drug reactions. Ann Intern Med. 1999 Jul 20;131(2):81-7. — View Citation

Malow RM, Baker SM, Klimas N, Antoni MH, Schneiderman N, Penedo FJ, Ziskind D, Page B, McMahon R. Adherence to complex combination antiretroviral therapies by HIV-positive drug abusers. Psychiatr Serv. 1998 Aug;49(8):1021-2, 1024. Erratum in: Psychiatr Serv 1998 Nov;49(11):1487. McPherson S [corrected to Baker SM]. — View Citation

Malta M, Magnanini MM, Strathdee SA, Bastos FI. Adherence to antiretroviral therapy among HIV-infected drug users: a meta-analysis. AIDS Behav. 2010 Aug;14(4):731-47. doi: 10.1007/s10461-008-9489-7. Epub 2008 Nov 20. — View Citation

Milam J, Richardson JL, McCutchan A, Stoyanoff S, Weiss J, Kemper C, Larsen RA, Hollander H, Weismuller P, Bolan R. Effect of a brief antiretroviral adherence intervention delivered by HIV care providers. J Acquir Immune Defic Syndr. 2005 Nov 1;40(3):356-63. — View Citation

Møller T, Linaker OM. Using brief self-reports and clinician scales to screen for substance use disorders in psychotic patients. Nord J Psychiatry. 2010 Apr;64(2):130-5. doi: 10.3109/08039480903274423. — View Citation

Nachega JB, Hislop M, Dowdy DW, Chaisson RE, Regensberg L, Maartens G. Adherence to nonnucleoside reverse transcriptase inhibitor-based HIV therapy and virologic outcomes. Ann Intern Med. 2007 Apr 17;146(8):564-73. — View Citation

Parsons JT, Golub SA, Rosof E, Holder C. Motivational interviewing and cognitive-behavioral intervention to improve HIV medication adherence among hazardous drinkers: a randomized controlled trial. J Acquir Immune Defic Syndr. 2007 Dec 1;46(4):443-50. — View Citation

Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. Erratum in: Ann Intern Med 2002 Feb 5;136(3):253. — View Citation

Petersen ML, Wang Y, van der Laan MJ, Guzman D, Riley E, Bangsberg DR. Pillbox organizers are associated with improved adherence to HIV antiretroviral therapy and viral suppression: a marginal structural model analysis. Clin Infect Dis. 2007 Oct 1;45(7):908-15. Epub 2007 Aug 20. — View Citation

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

Radloff L. The CES-D scale: a self-report depression scale for research in the general population. Appl Psych Meas. 1977;1:385-401

Reynolds NR, Neidig JL. Characteristics of nausea reported by HIV-infected patients initiating combination antiretroviral regimens. Clin Nurs Res. 2002 Feb;11(1):71-88. — View Citation

Rüütel K, Pisarev H, Loit HM, Uusküla A. Factors influencing quality of life of people living with HIV in Estonia: a cross-sectional survey. J Int AIDS Soc. 2009 Jul 16;12:13. doi: 10.1186/1758-2652-12-13. — View Citation

Rüütel K, Uusküla A, Minossenko A, Loit HM. Quality of life of people living with HIV and AIDS in Estonia. Cent Eur J Public Health. 2008 Sep;16(3):111-5. — View Citation

Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. — View Citation

Shapiro MF, Morton SC, McCaffrey DF, Senterfitt JW, Fleishman JA, Perlman JF, Athey LA, Keesey JW, Goldman DP, Berry SH, Bozzette SA. Variations in the care of HIV-infected adults in the United States: results from the HIV Cost and Services Utilization Study. JAMA. 1999 Jun 23-30;281(24):2305-15. — View Citation

Sherer R. Adherence and antiretroviral therapy in injection drug users. JAMA. 1998 Aug 12;280(6):567-8. — View Citation

Simoni JM, Pearson CR, Pantalone DW, Marks G, Crepaz N. Efficacy of interventions in improving highly active antiretroviral therapy adherence and HIV-1 RNA viral load. A meta-analytic review of randomized controlled trials. J Acquir Immune Defic Syndr. 2006 Dec 1;43 Suppl 1:S23-35. — View Citation

Sorensen JL, Haug NA, Delucchi KL, Gruber V, Kletter E, Batki SL, Tulsky JP, Barnett P, Hall S. Voucher reinforcement improves medication adherence in HIV-positive methadone patients: a randomized trial. Drug Alcohol Depend. 2007 Apr 17;88(1):54-63. Epub 2006 Oct 23. — View Citation

Stone VE. Strategies for optimizing adherence to highly active antiretroviral therapy: lessons from research and clinical practice. Clin Infect Dis. 2001 Sep 15;33(6):865-72. Epub 2001 Aug 13. Review. — View Citation

Strathdee SA, Palepu A, Cornelisse PG, Yip B, O'Shaughnessy MV, Montaner JS, Schechter MT, Hogg RS. Barriers to use of free antiretroviral therapy in injection drug users. JAMA. 1998 Aug 12;280(6):547-9. — View Citation

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

Torres-Madriz G, Lerner D, Ruthazer R, Rogers WH, Wilson IB. Work-related barriers and facilitators to antiretroviral therapy adherence in persons living with HIV infection. AIDS Behav. 2011 Oct;15(7):1475-82. doi: 10.1007/s10461-010-9667-2. — View Citation

Uusküla A, Kalikova A, Zilmer K, Tammai L, DeHovitz J. The role of injection drug use in the emergence of Human Immunodeficiency Virus infection in Estonia. Int J Infect Dis. 2002 Mar;6(1):23-7. — View Citation

Uusküla A, Kals M, Rajaleid K, Abel K, Talu A, Rüütel K, Platt L, Rhodes T, Dehovitz J, Des Jarlais D. High-prevalence and high-estimated incidence of HIV infection among new injecting drug users in Estonia: need for large scale prevention programs. J Public Health (Oxf). 2008 Jun;30(2):119-25. doi: 10.1093/pubmed/fdn014. Epub 2008 Feb 28. — View Citation

WHO/UNAIDS/UNICEF. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector: progress report, April 2007. http://www.who.int/hiv/mediacentre/universal_access_progress_report_en.pdf

Wolfe D. Paradoxes in antiretroviral treatment for injecting drug users: access, adherence and structural barriers in Asia and the former Soviet Union. Int J Drug Policy. 2007 Aug;18(4):246-54. Epub 2007 Mar 23. — View Citation

* Note: There are 41 references in allClick 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
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