Extending HIV Care Beyond the Rural Health Center
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Purpose
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 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 |
- Adherence [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
- 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Kenya | |
| Mosoriot Rural Health Center | |
| Mosoriot, Kenya | |
| Principal Investigator: | Kara K Wools-Kaloustian, MD | Indiana University School of Medicine |
More Information
No publications provided by Indiana University
Additional 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:
|
Africa Antiretrovirals |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 19, 2013