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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00991302
First received: October 7, 2009
Last updated: July 30, 2015
Last verified: July 2015
Results First Received: July 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   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
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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  
Number of Participants  
[units: participants]
  86     86     172  
Age  
[units: years]
Mean (Standard Deviation)
  31  (8)     32  (10)     31  (9)  
Age, Customized  
[units: participants]
     
18-29     48     43     91  
30-39     25     23     48  
40-49     10     14     24  
50+     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┬ácopies/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
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1.  Primary:   Mean Self-reported Adherence Score (%) Over a One-month Recall   [ Time Frame: From week 4 to week 48 ]

2.  Secondary:   Mean Self-reported Adherence Score Over a One-month Recall   [ Time Frame: From week 4 to week 72 ]

3.  Secondary:   Time to Change of Initial Antiretroviral (ARV) Treatment Regimen   [ 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) Scores   [ Time Frame: Measured at entry and at Weeks 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, 10654
Study First Received: October 7, 2009
Results First Received: July 29, 2015
Last Updated: July 30, 2015
Health Authority: United States: Federal Government