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| ID | Type | Description | Link |
|---|---|---|---|
| 3.2.1001.11-0020 | Other Grant/Funding Number | ERDF, Estonian Healthcare Programme, self-funding |
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| Name | Class |
|---|---|
| National Institute for Health Development, Estonia | OTHER_GOV |
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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.
Specific antiretroviral therapy (ART) can suppress HIV replication and consequently preserve the functioning of immune system. ART is a lifelong treatment with several different concomitantly administered oral medications. According to studies, low adherence to treatment is directly related to knowledge and beliefs about ART.
Studies have shown the success of different interventions increasing adherence to ART, 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 easily incorporated into the working routine of an medical institution (clinic) with limited extra resources.
Primary locations to implement activities directed at improving treatment adherence are medical institutions, i.e. the departments of infectious diseases where persons living with HIV/AIDS receive their ART.
The aim of the study is to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving ART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Situated Optimal Adherence Intervention | Experimental | Situated Optimal Adherence Intervention: see 'Interventions' for more details. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Situated Optimal Adherence Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA Count / Viral Load (VL) | Undetectable viral load: HIV-1 RNA <40 copies/mL | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anneli Uusküla, MD, MSc, PhD | University of Tartu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West-Tallinn Central Hospital | Tallinn | Harju | 10617 | Estonia | ||
| East-Viru Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10928201 | Background | 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. | |
| 22460228 |
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Currently considering.
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519 participants (259 intervention + 260 control arm) randomized. Written informed consent forms of 2 not available (filed). Post-randomization study site control revealed 5 participants not having met the inclusion criterion 'receive or start (on recruitment date) ART'. Data of 512 participants (254 intervention + 258 control arm) analysed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Situated Optimal Adherence Intervention | Situated Optimal Adherence Intervention: see 'Interventions' for more details. Situated Optimal Adherence Intervention: 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. |
| FG001 | Adherence Counseling, Standard of Care | Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Situated Optimal Adherence Intervention | Situated Optimal Adherence Intervention: see 'Interventions' for more details. Situated Optimal Adherence Intervention: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure) | Number of participants who completed the study | Posted | Number | participants | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Situated Optimal Adherence Intervention | Situated Optimal Adherence Intervention: see 'Interventions' for more details. Situated Optimal Adherence Intervention: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Anneli Uusküla | Department of Public Health, University of Tartu, ESTONIA | +372 7374195 | anneli.uuskula@ut.ee |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| Kohtla-Järve |
| Ida-Virumaa |
| 31025 |
| Estonia |
| Background |
| 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. |
| 18838059 | Background | 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. |
| 16846321 | Background | 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. |
| 22533736 | Background | 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. |
| 21142588 | Background | 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. |
| BG001 | Adherence Counseling, Standard of Care | Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Viral load | HIV-1 RNA (viral load) with sensitivity of 40 copies/mL. | Number | participants |
|
| Treatment adherence | Patient self-reported 3-day recall measure: Counting pills prescribed and taken in past 3 days. Adherent when >=95% of pills taken as prescribed. | Number | participants |
|
| OG001 | Adherence Counseling, Standard of Care | Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed. |
|
|
| Secondary | HIV-1 RNA Count / Viral Load (VL) | Undetectable viral load: HIV-1 RNA <40 copies/mL | Number of participants who completed the 12-month study | Posted | Number | participants | 12 months |
|
|
|
| 0 |
| 254 |
| 0 |
| 254 |
| EG001 | Adherence Counseling, Standard of Care | Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed. | 0 | 258 | 0 | 258 |
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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 |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| detectable VL at baseline and 12 months |
|
| detectable VL at baseline, undetectable at 12 mo |
|
| data not available (at month 12) |
|