MedDataX Logo

Improving Treatment Adherence in HIV-Infected Individuals

NCT ID: NCT00247611

Last Updated: 2013-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

594 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Antiretroviral Therapy (ART) Adherence Health Behavior

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

HIV AIDS Antiretroviral Medication Adherence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Participants will receive the control condition

Group Type OTHER

Control

Intervention Type 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.

Intervention

Participants will receive the LifeWindows Intervention sessions

Group Type EXPERIMENTAL

LifeWindows Intervention Sessions

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Marked cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeffrey Fisher

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey D. Fisher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

K. Rivet Amico*, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut (*co-PI)

Deborah H. Cornman*, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut (*co-PI)

William A. Fisher*, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario (*co-PI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Yale-New Haven Hospital Nathan Smith Clinic

New Haven, Connecticut, United States

Site Status

Hospital of Saint Raphael

New Haven, Connecticut, United States

Site Status

Waterbury Hospital

Waterbury, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21452051 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ncbi.nlm.nih.gov/pubmed/21452051

PubMed record of results article

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH066684

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR 9A-ASPG

Identifier Type: -

Identifier Source: secondary_id

R01MH066684

Identifier Type: NIH

Identifier Source: org_study_id

View Link