Extending HIV Care Beyond the Rural Health Center

NCT ID: NCT00371540

Last Updated: 2016-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-04-30

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.

Conditions

HIV; HIV Infections

Keywords

Africa; Antiretrovirals

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

I

Routine care in the clinic

Group Type: NO_INTERVENTION

No interventions assigned to this group

II

Follow-up in clinic every 3 months, home visits monthly

Group Type: EXPERIMENTAL

Home visit by community care coordinators

Intervention Type: OTHER

Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moi Univeristy

OTHER

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Kara Wools-Kaloustian

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kara K Wools-Kaloustian, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Mosoriot Rural Health Center

Mosoriot, , Kenya

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 20683336 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19788755 (View on PubMed)

Other Identifiers

DDCF 2005043

Identifier Type: -

Identifier Source: org_study_id