NCT01997359|Completed
Multi-level Determinants of Starting ART Late: Aim 3
LSTART
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LSTART
Sponsor study identifier
Secondary identifiers
NIH
observational
1,214
1 country
6
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 8, 2013
Actual (reported)November 28, 2013
Actual (reported)April 2014
Actual (reported)April 2014
Actual (reported)Proportion of Persons Initiating ART Late
12 months
Eligible patients will undergo a one hour structured interview about barriers and facilitators to early ART initiation.
The prospective cohort will include all patients initiating ART at one of the six study sites, estimated at 1,200 patients. Cases will be adults initiating ART with either: CD4 count \<150 cells/µL. Controls will be adults who initiate ART with CD4≥200 . Individuals initiating ART with CD4 counts of 150-199 cells per µL and at WHO Stage I-III will be excluded from the case-control analysis in order to ensure meaningful distinction between the two groups. We will enroll 720 patients for the case control study nested in the prospective cohort, which will include 360 cases and 360 controls, who will be frequency matched by sex, month of ART initiation, and clinic.
The prospective cohort will include all patients initiating ART at one of the six study sites, estimated at 1,200 patients. Cases will be adults initiating ART with either: CD4 count \<150 cells/µL. Controls will be adults who initiate ART with CD4≥200 . Individuals initiating ART with CD4 counts of 150-199 cells per µL and at WHO Stage I-III will be excluded from the case-control analysis in order to ensure meaningful distinction between the two groups. We will enroll 720 patients for the case control study nested in the prospective cohort, which will include 360 cases and 360 controls, who will be frequency matched by sex, month of ART initiation, and clinic.
Ambo Hospital
Āmbo, Ethiopia
Bishoftu Hospital
Bishoftu, Ethiopia
Fitche Hospital
Fichē, Ethiopia
Goba Hospital
Goba, Ethiopia
Nekemte Hospital
Nekemte, Ethiopia
Shashamene Hospital
Shashamene, Ethiopia
Batya Elul, PhD, MSc
ICAP-NY, Columbia University
1,214 participants (actual enrollment reported by the registry).
First Submitted
November 8, 2013
First Posted
November 28, 2013
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
December 16, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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