Improving Treatment Adherence in HIV-Infected Individuals

NCT00247611 | Completed Phase 2 Results DMC

• 2 other identifiers: R01MH066684DAHBR 9A-ASPG
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 5

Brief Summary

This study will develop and evaluate the efficacy of an individualized, interactive, computer software program delivered in conjunction with clinical care in increasing and supporting antiretroviral therapy adherence in HIV-infected individuals.

Conditions

HIV Antiretroviral Therapy (ART) Adherence; Health Behavior

Keywords

HIV; AIDS; Antiretroviral Medication Adherence

Outcome Measures

Primary Outcomes (2)

• AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken

  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

  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

Secondary Outcomes (1)

• Viral Load Count

  Measured over 18 months

Study Arms (2)

Control

OTHER

Participants will receive the control condition

Other: Control

Intervention

EXPERIMENTAL

Participants will receive the LifeWindows Intervention sessions

Behavioral: LifeWindows Intervention Sessions

Interventions

LifeWindows Intervention Sessions BEHAVIORAL

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.

Intervention

Control OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected
• English-speaking
• Currently receiving treatment at one of the participating sites
• Currently receiving antiretroviral therapy

You may not qualify if:

• Marked cognitive impairment

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

University of Connecticut Health Center

Farmington, Connecticut, 06030-3212, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale-New Haven Hospital Nathan Smith Clinic

New Haven, Connecticut, 06510, United States

Location

Hospital of Saint Raphael

New Haven, Connecticut, 06511, United States

Location

Waterbury Hospital

Waterbury, Connecticut, 06708, United States

Location

Related Publications (1)

• Fisher JD, Amico KR, Fisher WA, Cornman DH, Shuper PA, Trayling C, Redding C, Barta W, Lemieux AF, Altice FL, Dieckhaus K, Friedland G; LifeWindows Team. Computer-based intervention in HIV clinical care setting improves antiretroviral adherence: the LifeWindows Project. AIDS Behav. 2011 Nov;15(8):1635-46. doi: 10.1007/s10461-011-9926-x.

  PMID: 21452051 RESULT

Related Links

• PubMed record of results article

MeSH Terms

Conditions

Health Behavior; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

* The only empirical demonstration of LifeWindows outcomes to date * OP sample was defined a posteriori * Under-powered to detect changes in Viral Load

Results Point of Contact

• Title: Dr. Jeffrey Fisher, Principal Investigator
• Organization: Center for Health, Intervention & Prevention

jeffrey.fisher@uconn.edu

(860) 486-4940

Study Officials

• Jeffrey D. Fisher, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

• K. Rivet Amico*, PhD

  University of Connecticut (*co-PI)

  PRINCIPAL INVESTIGATOR

• Deborah H. Cornman*, PhD

  University of Connecticut (*co-PI)

  PRINCIPAL INVESTIGATOR

• William A. Fisher*, PhD

  University of Western Ontario (*co-PI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 2, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: December 20, 2013
• Results First Posted: December 20, 2013

Record last verified: 2013-11

Locations

US (5)