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Extending HIV Care Beyond the Rural Health Center

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Home visit by community care coordinators
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Africa, Antiretrovirals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mosoriot Rural Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

I

II

Arm Description

Routine care in the clinic

Follow-up in clinic every 3 months, home visits monthly

Outcomes

Primary Outcome Measures

Lost to Follow-up
Number of Subjects Lost to follow-up

Secondary Outcome Measures

Viral Load
Detectable VL at 12 months
Death

Full Information

First Posted
August 31, 2006
Last Updated
November 1, 2016
Sponsor
Indiana University School of Medicine
Collaborators
Moi Univeristy
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1. Study Identification

Unique Protocol Identification Number
NCT00371540
Brief Title
Extending HIV Care Beyond the Rural Health Center
Official Title
Extending HIV Care Beyond the Rural Health Center
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Moi Univeristy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
Africa, Antiretrovirals

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
No Intervention
Arm Description
Routine care in the clinic
Arm Title
II
Arm Type
Experimental
Arm Description
Follow-up in clinic every 3 months, home visits monthly
Intervention Type
Other
Intervention Name(s)
Home visit by community care coordinators
Intervention Description
Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.
Primary Outcome Measure Information:
Title
Lost to Follow-up
Description
Number of Subjects Lost to follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Viral Load
Description
Detectable VL at 12 months
Time Frame
12 months
Title
Death
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV infected >18 years old household members are aware of the patient's HIV infection 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: active opportunistic infection pregnant hospitalized in the previous 3 months unable to understand the informed consent process due to mental or physical incapacity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara K Wools-Kaloustian, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mosoriot Rural Health Center
City
Mosoriot
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
20683336
Citation
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.
Results Reference
derived
PubMed Identifier
19788755
Citation
Wools-Kaloustian KK, Sidle JE, Selke HM, Vedanthan R, Kemboi EK, Boit LJ, Jebet VT, Carroll AE, Tierney WM, Kimaiyo S. A model for extending antiretroviral care beyond the rural health centre. J Int AIDS Soc. 2009 Sep 29;12:22. doi: 10.1186/1758-2652-12-22.
Results Reference
derived

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Extending HIV Care Beyond the Rural Health Center

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