Extending HIV Care Beyond the Rural Health Center

Study Overview
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Brief Summary
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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.

Official Title
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Extending HIV Care Beyond the Rural Health Center

Conditions
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HIV, HIV Infections

Intervention / Treatment
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* Other: Home visit by community care coordinators


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: I<br>Routine care in the clinic | |
| Experimental: II<br>Follow-up in clinic every 3 months, home visits monthly | Other: Home visit by community care coordinators<br>* Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lost to Follow-up | Number of Subjects Lost to follow-up | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Load | Detectable VL at 12 months | 12 months | 
| Death |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Africa, Antiretrovirals