Improving Treatment Adherence in HIV-Infected Individuals

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Fisher, University of Connecticut
ClinicalTrials.gov Identifier:
NCT00247611
First received: October 31, 2005
Last updated: November 26, 2013
Last verified: November 2013
Results First Received: August 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Antiretroviral Therapy (ART) Adherence
Health Behavior
Interventions: Behavioral: LifeWindows Intervention Sessions
Other: Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
HIV + patients were recruited via provider referral and notices about the study posted in five large HIV care clinics in Connecticut, USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Participants will receive the control condition
Intervention Participants will receive the LifeWindows Intervention sessions

Participant Flow for 3 periods

Period 1:   Baselined
    Control     Intervention  
STARTED     304 [1]   290 [1]
COMPLETED     287 [2]   277 [2]
NOT COMPLETED     17     13  
Completed baseline, never placed on ARVs                 8                 5  
Completed baseline only                 9                 8  
[1] Participants randomized
[2] Randomized participants who completed at least 2 adherence assessments/sessions

Period 2:   Intention to Treat Sample
    Control     Intervention  
STARTED     304 [1]   290 [1]
COMPLETED     287 [2]   277 [2]
NOT COMPLETED     17     13  
[1] Participants randomized
[2] Randomized participants who completed at least 2 adherence assessments/sessions

Period 3:   On Protocol Sample
    Control     Intervention  
STARTED     287 [1]   277 [1]
COMPLETED     176 [2]   152 [2]
NOT COMPLETED     111     125  
[1] ITT sample participants
[2] Participants with no interruptions in ART receipt and completing 6 or more LifeWindows assessments



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics provided for randomized sample. Analyses were conducted on those with >=2 adherence assessments for ITT.

Reporting Groups
  Description
Control Participants will receive the control condition
Intervention Participants will receive the LifeWindows Intervention sessions
Total Total of all reporting groups

Baseline Measures
    Control     Intervention     Total  
Number of Participants  
[units: participants]
  304     290     594  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     301     284     585  
>=65 years     3     6     9  
Age [2]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     174     149     323  
>=65 years     2     3     5  
Age [1]
[units: years]
Mean ± Standard Deviation
  47.28  ± 8.01     46.76  ± 8.00     47  ± 8  
Gender [1]
[units: participants]
     
Female     119     110     229  
Male     185     180     365  
Gender [3]
[units: participants]
     
Female     72     66     138  
Male     104     86     190  
Region of Enrollment [1]
[units: participants]
     
United States     304     290     594  
[1] Intent to Treat (ITT) Sample
[2] On Protocol (OP) The On-Protocol sample was derived from the ITT sample who also had completed >=6 assessments and had no ART receipt interruptions.
[3] On Protocol (OP)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   AIDS Clinical Trials Group (ACTG) 3-day Recall Measure of Doses Taken   [ Time Frame: Measured at each clinical care visit over 18 months of participation ]

2.  Primary:   Visual Analog Scale Measure of Adherence to ART   [ Time Frame: Measured at each clinical visit over 18 months of participation ]

3.  Secondary:   Viral Load Count   [ Time Frame: Measured over 18 months ]

4.  Post-Hoc:   Percentage of Participants Unemployed and on Disability   [ Time Frame: Data collected at Baseline ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • 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:  
Name/Title: Dr. Jeffrey Fisher, Principal Investigator
Organization: Center for Health, Intervention & Prevention
phone: (860) 486-4940
e-mail: jeffrey.fisher@uconn.edu


Publications of Results:

Responsible Party: Jeffrey Fisher, University of Connecticut
ClinicalTrials.gov Identifier: NCT00247611     History of Changes
Other Study ID Numbers: R01 MH66684, R01MH066684, DAHBR 9A-ASPG
Study First Received: October 31, 2005
Results First Received: August 1, 2013
Last Updated: November 26, 2013
Health Authority: United States: Federal Government