Improving Treatment Adherence in HIV-Infected Individuals
Changing ART Adherence Behavior: The Lifewindows Project
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
When antiretroviral therapy (ART) is taken correctly, it can dramatically improve the health and well-being of HIV-infected individuals. However, when the treatment regimen is not followed carefully, the therapy can be ineffective in managing one's HIV, and also can allow for the development of strains of HIV that may be resistant to treatment. Effective ART adherence interventions can help patients to avoid potentially serious individual and public health consequences of suboptimal adherence, but such interventions are often expensive and too intensive for clinics to support offering over time to their patients. This study will develop and evaluate the effectiveness of an individualized, interactive, computer-software intervention program delivered in clinical care in increasing ART adherence in HIV-infected individuals. Because the intervention is a software program, clinic resources required for implementation and sustaining availability over time are minimized.
Participants in this ~18-month study were recruited from one of 5 participating clinics that provide HIV care and randomly assigned to control (an assessment only version of the software) or intervention (assessment and tailored intervention software) arm. Participants completed their assigned task in concert with their regularly scheduled HIV medical care visits (but no more frequently than once a month). Primary outcomes were measured at each medical visit. The effect of the adherence intervention was evaluated through comparison of treatment and control arm adherence reports over time and VL.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06030-3212
- University of Connecticut Health Center
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Hartford, Connecticut, Forenede Stater, 06102
- Hartford Hospital
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New Haven, Connecticut, Forenede Stater, 06511
- Hospital of Saint Raphael
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New Haven, Connecticut, Forenede Stater, 06510
- Yale-New Haven Hospital Nathan Smith Clinic
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Waterbury, Connecticut, Forenede Stater, 06708
- Waterbury Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- HIV-infected
- English-speaking
- Currently receiving treatment at one of the participating sites
- Currently receiving antiretroviral therapy
Exclusion Criteria:
- Marked cognitive impairment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Control
Participants will receive the control condition
|
At each clinical care visit, control arm participants use the portion of the LifeWindows software program that provides a welcome from the avatar and collection of assessment items/surveys.
|
|
Eksperimentel: Intervention
Participants will receive the LifeWindows Intervention sessions
|
At each clinical care visit, intervention arm participants use the full LifeWindows program, which includes welcome and assessment surveys and also includes the active intervention modules.
ART adherence promotion intervention activities are tailored to the participant's assessment responses.
Participants select which activities he or she wishes to use which culminates in an adherence specific goal.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken
Tidsramme: Measured at each clinical care visit over 18 months of participation
|
This measure asks participants to report the number of doses taken on each of the past 3-days, relative to number he or she was prescribed to take, and produces a % adherence score. For this study, adherence over the past 3-days was established for each medication separately then averaged over the full regimen. For main outcomes, perfect vs imperfect adherence was evaluated. Significant findings on perfect/imperfect adherence were followed with sensitivity tests to determine if lowest threshold (eg., 90%, 80%, 70% adherence) effect was maintained. See: Chesney MA, Ickovics JR, Chambers DB, et al. 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;12(3):255-266. |
Measured at each clinical care visit over 18 months of participation
|
|
Visual Analog Scale Measure of Adherence to ART
Tidsramme: Measured at each clinical visit over 18 months of participation
|
This measure asks participants to rate their adherence over the past 3 to 4 weeks using a line that marks from 0 to 100% of doses taken. For this study, this item was asked for each antiretroviral in one's regimen and a total score was produced by averaging all reports. For main outcomes, perfect vs imperfect adherence was evaluated. See: Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS.2002;16:269-77 |
Measured at each clinical visit over 18 months of participation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Viral Load Count
Tidsramme: Measured over 18 months
|
Viral load data extracted from medical records beginning 30 days prior to baseline.
|
Measured over 18 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jeffrey D. Fisher, PhD, University of Connecticut
- Ledende efterforsker: K. Rivet Amico*, PhD, University of Connecticut (*co-PI)
- Ledende efterforsker: Deborah H. Cornman*, PhD, University of Connecticut (*co-PI)
- Ledende efterforsker: William A. Fisher*, PhD, University of Western Ontario (*co-PI)
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- R01MH066684 (U.S. NIH-bevilling/kontrakt)
- DAHBR 9A-ASPG (National Institute of Mental Health (NIMH-DAHBR))
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