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| Name | Class |
|---|---|
| Moi Univeristy | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | No Intervention | Routine care in the clinic | |
| II | Experimental | Follow-up in clinic every 3 months, home visits monthly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home visit by community care coordinators | Other | Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lost to Follow-up | Number of Subjects Lost to follow-up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load | Detectable VL at 12 months | 12 months |
| Death | 12 months |
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Inclusion Criteria:
6) willing to consent to participate.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara K Wools-Kaloustian, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mosoriot Rural Health Center | Mosoriot | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20683336 | Derived | 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. | |
| 19788755 |
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| ID | Title | Description |
|---|---|---|
| FG000 | I Routine Care | Routine care in the clinic |
| FG001 | II Home Visits | Follow-up in clinic every 3 months, home visits monthly 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
HIV infected patients who were clinically stable on ART for at least 3 months
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| ID | Title | Description |
|---|---|---|
| BG000 | I Routine Care | Routine care in the clinic |
| BG001 | II Home Visits | Follow-up in clinic every 3 months, home visits monthly 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Viral Load | Detectable VL at 12 months | Posted | Number | participants | 12 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I Rountine Care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Injury, poisoning and procedural complications | Systematic Assessment | Patient self prescribed and administered an herbal Abortifacient precipitating hemorrhage and death. This death was not related to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Wools-Kaloustian | Indiana University School of Medicine | 317-274-7936 | kwools@iu.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Lost to Follow-up | Number of Subjects Lost to follow-up | Posted | Number | participants | 12 months |
|
|
|
|
| Secondary | Death | Posted | Number | participants | 12 months |
|
|
|
|
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | II Home Visits | 1 | 96 | 0 | 96 |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |