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N/A N=208 Randomized Single-blind Treatment

Extending HIV Care Beyond the Rural Health Center

HIV · HIV Infections

Enrolled (actual)
208
Serious AEs
0.5%
Results posted
Oct 2016
Primary outcome: Primary: Lost to Follow-up — 5; 5 participants — p=1.0

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Home visit by community care coordinators (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Apr 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Lost to Follow-up
5; 5 1.0
SECONDARY
Viral Load
13; 9 0.65
SECONDARY
Death
0; 1 <0.05 sig

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

  • 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.

Exclusion Criteria

  • active opportunistic infection
  • pregnant
  • hospitalized in the previous 3 months
  • unable to understand the informed consent process due to mental or physical incapacity.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00371540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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