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Extending HIV Care Beyond the Rural Health Center

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ClinicalTrials.gov Identifier: NCT00371540
Recruitment Status : Completed
First Posted : September 4, 2006
Results First Posted : October 26, 2016
Last Update Posted : December 20, 2016
Sponsor:
Collaborator:
Moi Univeristy
Information provided by (Responsible Party):
Kara Wools-Kaloustian, Indiana University

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
Enrollment 208
Recruitment Details  
Pre-assignment Details  
Arm/Group Title I Routine Care II Home Visits
Hide Arm/Group Description Routine care in the clinic

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.

Period Title: Overall Study
Started 112 96
Completed 102 87
Not Completed 10 9
Arm/Group Title I Routine Care II Home Visits Total
Hide Arm/Group Description Routine care in the clinic

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 of all reporting groups
Overall Number of Baseline Participants 112 96 208
Hide Baseline Analysis Population Description
HIV infected patients who were clinically stable on ART for at least 3 months
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 96 participants 208 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 96 participants 208 participants
Female
81
  72.3%
71
  74.0%
152
  73.1%
Male
31
  27.7%
25
  26.0%
56
  26.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Kenya Number Analyzed 112 participants 96 participants 208 participants
112 96 208
1.Primary Outcome
Title Lost to Follow-up
Hide Description Number of Subjects Lost to follow-up
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title I Rountine Care II Home Visits
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 112 96
Measure Type: Number
Unit of Measure: participants
5 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection I Rountine Care, II Home Visits
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Viral Load
Hide Description Detectable VL at 12 months
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title I Rountine Care II Home Visits
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 96 86
Measure Type: Number
Unit of Measure: participants
13 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection I Rountine Care, II Home Visits
Comments Note: The differences between the number of individuals evaluable for this secondary outcome and the number of individuals evaluable for the primary outcome is related to specimen loss by the laboratory. As such of the Routine care group only 96 of 102 patients completing the study were evaluable for the viral load outcome and only 86 of 87 patients in the Home visit group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Death
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title I Rountine Care II Home Visits
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 112 96
Measure Type: Number
Unit of Measure: participants
0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection I Rountine Care, II Home Visits
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title I Rountine Care II Home Visits
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
I Rountine Care II Home Visits
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
I Rountine Care II Home Visits
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      1/96 (1.04%)    
Injury, poisoning and procedural complications     
Death  [1]  0/112 (0.00%)  0 1/96 (1.04%)  1
Indicates events were collected by systematic assessment
[1]
Patient self prescribed and administered an herbal Abortifacient precipitating hemorrhage and death. This death was not related to the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
I Rountine Care II Home Visits
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      0/96 (0.00%)    
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
EMail: kwools@iu.edu
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