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Durability of Adherence in Self-Management of HIV (DASH)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00991302
First received: October 7, 2009
Last updated: September 12, 2015
Last verified: September 2015
Results First Received: July 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Behavioral: CAP-IT

  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
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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
CAP-IT

Participants received the modified CAP-IT adherence intervention in addition to standard care.

Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)

Standard Care Participants received standard care.

Participant Flow:   Overall Study
    CAP-IT   Standard Care
STARTED   86   86 
COMPLETED   72   73 
NOT COMPLETED   14   13 
Death                0                1 
Lost to Follow-up                14                12 



  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.
Intention to treat: All eligible participants were included in the baseline characteristics.

Reporting Groups
  Description
CAP-IT

Participants received the modified CAP-IT adherence intervention in addition to standard care.

Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)

Standard Care Participants received standard care.
Total Total of all reporting groups

Baseline Measures
   CAP-IT   Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   86   172 
Age 
[Units: Years]
Mean (Standard Deviation)
 31  (8)   32  (10)   31  (9) 
Age, Customized 
[Units: Participants]
     
18-29 years   48   43   91 
30-39 years   25   23   48 
40-49 years   10   14   24 
50+ years   3   6   9 
Gender 
[Units: Participants]
     
Female   1   5   6 
Male   85   81   166 
Race/Ethnicity, Customized 
[Units: Participants]
     
White Non-Hispanic   7   16   23 
Black Non-Hispanic   4   1   5 
Hispanic (Regardless of Race)   73   62   135 
Asian, Pacific Islander   0   3   3 
More than Once Race   1   1   2 
Missing   1   3   4 
Region of Enrollment 
[Units: Participants]
     
United States   26   26   52 
Peru   60   60   120 
Regimen complexity 
[Units: Participants]
     
QD   25   25   50 
BID or TID   61   61   122 
HIV-1 RNA 
[Units: Log10 copies/mL]
Mean (Standard Deviation)
 4.9  (0.8)   5.0  (0.7)   5.0  (0.7) 
CD4+ T-cell count 
[Units: Cells/mm^3]
Mean (Standard Deviation)
 318  (178)   313  (213)   315  (195) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Self-reported Adherence Score (%) Over a One-month Recall   [ Time Frame: At weeks 4, 12, 24, 36, and 48 ]

2.  Secondary:   Mean Self-reported Adherence Score Over a One-month Recall   [ Time Frame: Weeks 4, 12, 24, 36, 48, 60, and 72 ]

3.  Secondary:   Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48   [ Time Frame: From study entry to week 48 ]

4.  Secondary:   Virologic Suppression   [ Time Frame: At week 24, 48, 72 ]

5.  Secondary:   Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score   [ Time Frame: At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72 ]

6.  Secondary:   Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)   [ Time Frame: From study entry to week 72 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
phone: (301) 628-3313
e-mail: ACTGCT.Gov@s-3.com


Publications:

Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00991302     History of Changes
Other Study ID Numbers: ACTG A5250
1U01AI068636 ( US NIH Grant/Contract Award Number )
10654
Study First Received: October 7, 2009
Results First Received: July 29, 2015
Last Updated: September 12, 2015