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Extending HIV Care Beyond the Rural Health Center

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371540
First Posted: September 4, 2006
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Moi Univeristy
Information provided by (Responsible Party):
Kara Wools-Kaloustian, Indiana University
Results First Submitted: August 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   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]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      112 100.0%      96 100.0%      208 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
     
Female      81  72.3%      71  74.0%      152  73.1% 
Male      31  27.7%      25  26.0%      56  26.9% 
Region of Enrollment 
[Units: Participants]
     
Kenya   112   96   208 


  Outcome Measures
  Show All Outcome Measures

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
First Submitted: August 31, 2006
First Posted: September 4, 2006
Results First Submitted: August 29, 2016
Results First Posted: October 26, 2016
Last Update Posted: December 20, 2016