Extending HIV Care Beyond the Rural Health Center

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

August 31, 2006
September 4, 2006
August 29, 2016
October 26, 2016
December 20, 2016
February 2006
April 2008   (Final data collection date for primary outcome measure)
Lost to Follow-up [ Time Frame: 12 months ]
Number of Subjects Lost to follow-up
  • viral load
  • Hospitalized
  • New opportunistic infect
  • Antiretroviral regimen failure
  • Loss to follow-up
  • Death
Complete list of historical versions of study NCT00371540 on Archive Site
  • Viral Load [ Time Frame: 12 months ]
    Detectable VL at 12 months
  • Death [ Time Frame: 12 months ]
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Extending HIV Care Beyond the Rural Health Center
Extending HIV Care Beyond the Rural Health Center
The objective of this application is to develop and assess a system which uses non-clinician extenders to provide selected aspects of HIV care in rural western Kenya. The plan is to train persons living with HIV/AIDS (PLWAs) to undertake this role as Community Care Coordinators. Our central hypothesis, is that PLWAs can be effective members of the health care team and that their involvement in community-based HIV care will facilitate patient access to services and improve outcomes. As such our two specific aims are: 1) To develop a sustainable system to extend HIV care into the community and to train the individuals necessary to support such a system (Community Care Coordinators). 2) To determine the impact of Community Care Coordinators on patient adherence (to drugs and to clinic visits), clinical outcomes (i.e. viral load responses [an individuals level of circulating HIV virus], inter-current opportunistic infections, hospitalization, drop out from the program, change to second line therapy and mortality) and patient perception of stigma. This study will provide invaluable data on the use of non-clinician care extenders for providing HIV care in resource poor settings. As such, knowledge gained from this study will assist in developing a model for non-clinician centered HIV care systems elsewhere in sub-Saharan Africa.
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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
  • HIV
  • HIV Infections
Other: 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.
  • No Intervention: I
    Routine care in the clinic
  • Experimental: II
    Follow-up in clinic every 3 months, home visits monthly
    Intervention: Other: Home visit by community care coordinators

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. HIV infected
  2. >18 years old
  3. household members are aware of the patient's HIV infection
  4. clinically stable on ARVs and no significant adherence issues for 3 months, 5) live in Kosirai Division

6) willing to consent to participate.

Exclusion Criteria:

  1. active opportunistic infection
  2. pregnant
  3. hospitalized in the previous 3 months
  4. unable to understand the informed consent process due to mental or physical incapacity.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
DDCF 2005043
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Not Provided
Kara Wools-Kaloustian, Indiana University
Indiana University School of Medicine
Moi Univeristy
Principal Investigator: Kara K Wools-Kaloustian, MD Indiana University School of Medicine
Indiana University
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP