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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

Brief Summary:
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.

Condition or disease Intervention/treatment
HIV HIV Infections Other: Home visit by community care coordinators

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Extending HIV Care Beyond the Rural Health Center
Study Start Date : February 2006
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: I
Routine care in the clinic
Experimental: II
Follow-up in clinic every 3 months, home visits monthly
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.

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

Secondary Outcome Measures :
  1. Viral Load [ Time Frame: 12 months ]
    Detectable VL at 12 months

  2. Death [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00371540

Mosoriot Rural Health Center
Mosoriot, Kenya
Sponsors and Collaborators
Indiana University School of Medicine
Moi Univeristy
Principal Investigator: Kara K Wools-Kaloustian, MD Indiana University School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kara Wools-Kaloustian, Associate Professor, Indiana University Identifier: NCT00371540     History of Changes
Other Study ID Numbers: DDCF 2005043
First Posted: September 4, 2006    Key Record Dates
Results First Posted: October 26, 2016
Last Update Posted: December 20, 2016
Last Verified: November 2016

Keywords provided by Kara Wools-Kaloustian, Indiana University:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases