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

August 31, 2006
August 26, 2008
February 2006
April 2008   (final data collection date for primary outcome measure)
Adherence [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • viral load
  • Hospitalized
  • New opportunistic infect
  • Antiretroviral regimen failure
  • Loss to follow-up
  • Death
Complete list of historical versions of study NCT00371540 on ClinicalTrials.gov Archive Site
  • 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 ]
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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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Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
  • HIV
  • HIV Infections
  • Behavioral: Control Group
    Routine care in the clinic on a monthly basis
  • 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
    Intervention: Behavioral: Control Group
  • Experimental: II
    Follow-up in clinic every 3 months, home visits monthly
    Intervention: Other: Home visit by community care coordinators
Selke HM, Kimaiyo S, Sidle JE, Vedanthan R, Tierney WM, Shen C, Denski CD, Katschke AR, Wools-Kaloustian K. Task-shifting of antiretroviral delivery from health care workers to persons living with HIV/AIDS: clinical outcomes of a community-based program in Kenya. J Acquir Immune Defic Syndr. 2010 Dec;55(4):483-90. doi: 10.1097/QAI.0b013e3181eb5edb.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov 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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
DDCF 2005043
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Kara Wools-Kaloustian M.D., Indiana University School of Medicine
Indiana University School of Medicine
Moi Univeristy
Principal Investigator: Kara K Wools-Kaloustian, MD Indiana University School of Medicine
Indiana University
August 2008

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