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Sponsors and Collaborators: |
Indiana University School of Medicine Moi Univeristy |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00371540 |
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 | Intervention |
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HIV HIV Infections |
Behavioral: Control Group Other: Home visit by community care coordinators |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety Study |
Official Title: | Extending HIV Care Beyond the Rural Health Center |
Enrollment: | 208 |
Study Start Date: | February 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: No Intervention
Routine care in the clinic
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Behavioral: Control Group
Routine care in the clinic on a monthly basis
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II: Experimental
Follow-up in clinic every 3 months, home visits monthly
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
6) willing to consent to participate.
Exclusion Criteria:
Kenya | |
Mosoriot Rural Health Center | |
Mosoriot, Kenya |
Principal Investigator: | Kara K Wools-Kaloustian, MD | Indiana University School of Medicine |
Responsible Party: | Indiana University School of Medicine ( Kara Wools-Kaloustian M.D. ) |
Study ID Numbers: | DDCF 2005043 |
Study First Received: | August 31, 2006 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00371540 History of Changes |
Health Authority: | United States: Institutional Review Board; Kenya: Ethical Review Committee |
Africa Antiretrovirals |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |