Human Immunodeficiency Virus (HIV) Clinical Trial
Official title:
Multi-level Determinants of Starting ART Late in Sub-Saharan Africa (LSTART Study): A Case-control Study to Identify Individual-level Risk Factors for Late ART Initiation in Ethiopia
The availability of HIV care and treatment programs is increasing in sub-Saharan Africa.
However more than half the patients who need HIV treatment are still not receiving
antiretroviral therapy (ART). This can lead to early death from AIDS. Additionally, many
patients start ART late after the HIV disease is very advanced. This results in high death
rates soon after starting ART. The factors that contribute to late ART initiation are still
unclear. This study will identify factors that help patients to enroll or prevent them from
enrolling into HIV care and starting ART on time. We will examine the characteristics of all
patients initiating ART at study sites. We will also look at potential risk factors among
patients who initiate ART late (cases) compared to patients who initiate earlier (controls)
at 6 HIV care and treatment clinics in Ethiopia. Data will be collected using 2 methods:
1. Face-to-face interviews with participants using questionnaires
2. Obtaining clinical data from the electronic patient-level database
Identifying factors that help patients to start or prevent them from starting ART on time
will help to direct interventions, programs and policies to reduce early death.
Background: Although HIV care and treatment programs are being scaled up in sub-Saharan
Africa, more than 50% of the patients in need of ART are not receiving it and there is still
significant mortality from AIDS. One of the major challenges is high rates of late ART
initiation (i.e., in the advanced stages of HIV disease) which results in high rates of
mortality soon after initiation of ART. The individual-level factors that contribute to late
ART initiation are still unclear. Objective: As the 3rd part of a 3-phase NIH-sponsored
project, this study aims to identify individual-level enablers and barriers to timely
enrollment into HIV care and ART initiation.
Methods: We will be recruiting all patients newly initiating ART at the study sites for
descriptive analysis (approximately 1,200). As a sub-analysis, we will be utilizing a
case-control approach to examine potential individual risk factors (e.g. knowledge and
behaviors around HIV care and treatment, experience of stigma, and other perceived barriers
and enablers to earlier HIV diagnosis, enrollment into care, and ART initiation) among 360
patients who initiated ART late (CD4 count <150 cells/µL compared to 360 patients who
initiated earlier (CD4≥200) at 6 HIV care and treatment clinics in Ethiopia. For both the
descriptive study and case-control study, data will be collected using 2 methods:
1. Face-to-face interviews with participants using structured questionnaires
2. Abstraction of clinical data from the electronic patient-level database to capture
patient information at baseline, 6 and 12 months after enrollment in the study
Expected use of results: Identifying individual-level enablers and barriers of timely ART
initiation will facilitate implementation of interventions, programs and policies to
mitigate the problem of late ART initiation.
;
Observational Model: Case Control, Time Perspective: Prospective
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