Extending HIV Care Beyond the Rural Health Center

NCT00371540 | Completed Results DMC

• 1 other identifier: DDCF 2005043
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Lost to Follow-up

  Number of Subjects Lost to follow-up

  12 months

Secondary Outcomes (2)

• Viral Load

  12 months

• Death

  12 months

Study Arms (2)

I

NO INTERVENTION

Routine care in the clinic

II

EXPERIMENTAL

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

Other: Home visit by community care coordinators

Interventions

Home visit by community care coordinators OTHER

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

II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \) willing to consent to participate.

You may not qualify if:

• active opportunistic infection
• pregnant
• hospitalized in the previous 3 months
• unable to understand the informed consent process due to mental or physical incapacity.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Moi Univeristy: collaborator

Study Sites (1)

Mosoriot Rural Health Center

Mosoriot, Kenya

Location

Related Publications (2)

• 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.

  PMID: 20683336 DERIVED

• 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.

  PMID: 19788755 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Kara Wools-Kaloustian
• Organization: Indiana University School of Medicine

kwools@iu.edu

317-274-7936

Study Officials

• Kara K Wools-Kaloustian, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 31, 2006
• First Posted: September 4, 2006
• Study Start: February 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 20, 2016
• Results First Posted: October 26, 2016

Record last verified: 2016-11

Locations

KE (1)