Extending HIV Care Beyond the Rural Health Center

HIV Infections Clinical Trial

Official title:

Extending HIV Care Beyond the Rural Health Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371540
• Other study ID #: DDCF 2005043
• Status: Completed
• Phase: N/A
• First received: August 31, 2006
• Last updated: August 26, 2008
• Start date: February 2006
• Est. completion date: April 2008

Study information

• Verified date: August 2008
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Behavioral:
• Control Group
Routine care in the clinic on a monthly basis

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.

Locations

Country	Name	City	State
Kenya	Mosoriot Rural Health Center	Mosoriot

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Moi Univeristy

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence		6 and 12 months	Yes
Secondary	Viral load		12 months	Yes
Secondary	Hospitalization		6 and 12 months	Yes
Secondary	New Opportunistic Infection		6 and 12 months	Yes
Secondary	Antiretroviral Regimen failure		6 and 12 months	Yes
Secondary	Lost to follow-up		12 months	Yes
Secondary	Death		12 months	Yes