HIV, HIV Infections
Conditions
Keywords
Africa, Antiretrovirals
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.
Interventions
OTHERHome 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.
Sponsors
Moi Univeristy
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lost to Follow-up | 12 months | Number of Subjects Lost to follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load | 12 months | Detectable VL at 12 months |
| Death | 12 months | — |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| I Routine Care Routine care in the clinic | 112 |
| II Home Visits Follow-up in clinic every 3 months, home visits monthly
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. | 96 |
| Total | 208 |
Baseline characteristics
| Characteristic | I Routine Care | II Home Visits | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 112 Participants | 96 Participants | 208 Participants |
| Gender Female | 81 Participants | 71 Participants | 152 Participants |
| Gender Male | 31 Participants | 25 Participants | 56 Participants |
| Region of Enrollment Kenya | 112 participants | 96 participants | 208 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 112 | 0 / 96 |
| serious Total, serious adverse events | 0 / 112 | 1 / 96 |
Outcome results
Primary
Lost to Follow-up
Number of Subjects Lost to follow-up
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| I Rountine Care | Lost to Follow-up | 5 participants |
| II Home Visits | Lost to Follow-up | 5 participants |
p-value: 1Fisher Exact
Secondary
Death
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| I Rountine Care | Death | 0 participants |
| II Home Visits | Death | 1 participants |
p-value: <0.05Fisher Exact
Secondary
Viral Load
Detectable VL at 12 months
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| I Rountine Care | Viral Load | 13 participants |
| II Home Visits | Viral Load | 9 participants |
Comparison: Note: The differences between the number of individuals evaluable for this secondary outcome and the number of individuals evaluable for the primary outcome is related to specimen loss by the laboratory. As such of the Routine care group only 96 of 102 patients completing the study were evaluable for the viral load outcome and only 86 of 87 patients in the Home visit group.p-value: 0.65Fisher Exact