Improving Treatment Adherence in HIV-Infected Individuals
Recruitment status was Active, not recruiting
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Purpose
This study will develop and evaluate the effectiveness of an individualized, interactive, computer software program delivered in conjunction with clinical care in increasing and supporting antiretroviral therapy adherence in HIV-infected individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Health Behavior |
Behavioral: LifeWindows Intervention Sessions Behavioral: Control |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Changing ART Adherence Behavior: The Lifewindows Project |
- 3-day and VAS measures of adherence to ART [ Time Frame: Measured over 18 months ] [ Designated as safety issue: No ]
- CD4 and viral load count [ Time Frame: Measured over 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 594 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control
Participants will receive the control condition
|
Behavioral: Control
Control arm participants will also use the software program in conjunction with their HIV care visit, but the software only progresses through the assessment module and then exits the participant from the program.
|
|
Experimental: Intervention
Participants will receive the LifeWindows Intervention sessions
|
Behavioral: LifeWindows Intervention Sessions
Experimental arm participants will use the adherence intervention software (called LifeWindows) at each clinic visit. The software contains an assessment module that tailors a set of potential ART adherence promotion strategies that are offered to the individual participant. The participant will select a strategy and move on to select one of several offered intervention activities that address that strategy (e.g., a participant may engage in an interactive interview with a HIV care clinician to address learning more about how HIV medications work). The participant will then select a goal to work on based on that activity. This procedure will be repeated at each clinic visit, and progress made towards achieving goals selected at the previous session area will be assessed.
|
Detailed Description:
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 exactly, 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 overtime 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). Outcomes were measured at each medical visit, with self-reported adherence further supplemented by pharmacy refill data when available, and CD4, and VL. The effect of the adherence intervention is currently being evaluated through comparison of treatment and control arm adherence reports over time and disease progression indices.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-infected
- English-speaking
- Currently receiving treatment at one of the participating sites
- Currently receiving antiretroviral therapy
Exclusion Criteria:
- N/A
Contacts and Locations| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030-3212 | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102 | |
| Hospital of Saint Raphael | |
| New Haven, Connecticut, United States, 06511 | |
| Yale-New Haven Hospital Nathan Smith Clinic | |
| New Haven, Connecticut, United States, 06510 | |
| Waterbury Hospital | |
| Waterbury, Connecticut, United States, 06708 | |
| Principal Investigator: | Jeffrey D. Fisher, PhD | University of Connecticut |
| Principal Investigator: | K. Rivet Amico, PhD | University of Connecticut |
| Principal Investigator: | Deborah H. Cornman, PhD | University of Connecticut |
| Principal Investigator: | William A. Fisher, PhD | University of Western Ontario, Canada |
| Principal Investigator: | Frederick Altice | Yale-New Haven Hospital Nathan Smith Clinic |
| Principal Investigator: | Kevin Dieckhaus, MD | University of Connecticut Health Center |
| Principal Investigator: | Gerald Friedland, MD | Yale-New Haven Hospital Nathan Smith Clinic |
| Principal Investigator: | Jack Ross, MD | Hartford Hospital |
| Principal Investigator: | Merceditas Villanueva, MD | Waterbury Hospital |
| Principal Investigator: | Sharon Weissman, MD | Hospital of Saint Raphael |
| Principal Investigator: | Krystn Wagner | Yale-New Haven Hospital Nathan Smith Clinic |
More Information
No publications provided
| Responsible Party: | Jeffrey D. Fisher, PhD Principal Investigator, Center for Health, Intervention and Prevention |
| ClinicalTrials.gov Identifier: | NCT00247611 History of Changes |
| Other Study ID Numbers: | R01 MH66684-02, DAHBR 9A-ASPG |
| Study First Received: | October 31, 2005 |
| Last Updated: | December 4, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
HIV AIDS Medication Adherence |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013