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Extending HIV Care Beyond the Rural Health Center

This study has been completed.
Sponsor:
Collaborator:
Moi Univeristy
Information provided by (Responsible Party):
Kara Wools-Kaloustian, Indiana University
ClinicalTrials.gov Identifier:
NCT00371540
First received: August 31, 2006
Last updated: August 29, 2016
Last verified: August 2016
Results First Received: August 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Caregiver);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Intervention: Other: Home visit by community care coordinators

  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
No text entered.

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
I Routine Care Routine care in the clinic
II Home Visits

Follow-up in clinic every 3 months, home visits monthly

Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.


Participant Flow:   Overall Study
    I Routine Care   II Home Visits
STARTED   112   96 
COMPLETED   102   87 
NOT COMPLETED   10   9 



  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.
HIV infected patients who were clinically stable on ART for at least 3 months

Reporting Groups
  Description
I Routine Care Routine care in the clinic
II Home Visits

Follow-up in clinic every 3 months, home visits monthly

Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.

Total Total of all reporting groups

Baseline Measures
   I Routine Care   II Home Visits   Total 
Overall Participants Analyzed 
[Units: Participants]
 112   96   208 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   112   96   208 
>=65 years   0   0   0 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 37.5  (9.5)   38.7  (9.9)   NA [1] 
[1] Update to website made more than 5 years after the original analysis. Entire population stats were not done as part of the original analysis and individual participant data is not readily available for this update
Gender 
[Units: Participants]
     
Female   81   71   152 
Male   31   25   56 
Region of Enrollment 
[Units: Participants]
     
Kenya   112   96   208 


  Outcome Measures
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1.  Primary:   Lost to Follow-up   [ Time Frame: 12 months ]

2.  Secondary:   Viral Load   [ Time Frame: 12 months ]

3.  Secondary:   Death   [ Time Frame: 12 months ]


  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: Kara Wools-Kaloustian
Organization: Indiana University School of Medicine
phone: 317-274-7936
e-mail: kwools@iu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kara Wools-Kaloustian, Indiana University
ClinicalTrials.gov Identifier: NCT00371540     History of Changes
Other Study ID Numbers: DDCF 2005043
Study First Received: August 31, 2006
Results First Received: August 29, 2016
Last Updated: August 29, 2016
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee