Extending HIV Care Beyond the Rural Health Center

Not Applicable

Completed

• Conditions: HIV; HIV Infections
• Interventions: Other: Home visit by community care coordinators

• Registration Number: NCT00371540
• Lead Sponsor: Indiana University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-08-31
• Study First Posted: 2006-09-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2016-08-29
• Results First Submitted QC: 2016-08-29
• Results First Posted: 2016-10-26
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II	Home visit by community care coordinators	Follow-up in clinic every 3 months, home visits monthly

Primary Outcome Measures

Name	Time	Method
Lost to Follow-up	12 months	Number of Subjects Lost to follow-up

Secondary Outcome Measures

Name	Time	Method
Viral Load	12 months	Detectable VL at 12 months
Death	12 months

Trial Locations

Locations (1)

Mosoriot Rural Health Center; 🇰🇪 Mosoriot, Kenya