Clinical trial NCT00371540: Extending HIV Care Beyond the Rural Health Center
Official title: Extending HIV Care Beyond the Rural Health Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
HIV Infections
Keywords: Africa
Antiretrovirals
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Moi Univeristy
First posted: 2006-09-04
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Lost to Follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Viral Load
timeFrame: 12 months
measure: Death
timeFrame: 12 months
Other outcomes:
Locations:
city: Mosoriot
country: Kenya
facility: Mosoriot Rural Health Center
Study officials:
affiliation: Indiana University School of Medicine
name: Kara K Wools-Kaloustian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.