Extending HIV Care Beyond the Rural Health Center

This study has been completed.
Moi Univeristy
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
First received: August 31, 2006
Last updated: August 26, 2008
Last verified: August 2008
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
HIV Infections
Behavioral: Control Group
Other: Home visit by community care coordinators

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Extending HIV Care Beyond the Rural Health Center

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Adherence [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Viral load [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Hospitalization [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • New Opportunistic Infection [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Antiretroviral Regimen failure [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Lost to follow-up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
No Intervention: I
Routine care in the clinic
Behavioral: Control Group
Routine care in the clinic on a monthly basis
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kara Wools-Kaloustian M.D., Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00371540     History of Changes
Other Study ID Numbers: DDCF 2005043 
Study First Received: August 31, 2006
Last Updated: August 26, 2008
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee

Keywords provided by Indiana University:

ClinicalTrials.gov processed this record on May 26, 2016