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Multi-level Determinants of Starting ART Late: Aim 3 (LSTART)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Batya Elul, Columbia University
ClinicalTrials.gov Identifier:
NCT01997359
First received: November 8, 2013
Last updated: November 22, 2013
Last verified: November 2013

November 8, 2013
November 22, 2013
June 2012
April 2014   (final data collection date for primary outcome measure)
Appointment adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Abstraction data from electronic patient-level database will be assessed at enrollment (looking at all prior data), 6 months, and 12 months to assess appointment adherence.
Same as current
Complete list of historical versions of study NCT01997359 on ClinicalTrials.gov Archive Site
  • Frequency of clinical and CD4 monitoring [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Abstraction data from electronic patient-level database will be assessed at enrollment, 6 months, and 12 months will be used to assess the frequency of clinical and CD4 monitoring.
  • Mortality rates at 6 months and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Abstraction data from electronic patient-level database will be assessed at enrollment (looking at all prior data), 6 months, and 12 months to assess mortality rates of HIV-positive patients at 6 months and 12 months after they initiate ART.
  • Rate of Loss to Follow-Up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Abstraction data from electronic patient-level database will be assessed at enrollment (looking at all prior data), 6 months, and 12 months to assess rates of loss to follow-up at 6 and 12 months after patients initiate ART.
Same as current
Not Provided
Not Provided
 
Multi-level Determinants of Starting ART Late: Aim 3
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 [Patient Registry]
Observational Model: Case Control
Time Perspective: Prospective
12 Months
Not Provided
Non-Probability Sample

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.

  • Human Immunodeficiency Virus (HIV)
  • Acquired Immune Deficiency Syndrome (AIDS)
Not Provided
  • Key Informant Interviews
    Eligible patients will undergo a one hour structured interview about barriers and facilitators to early ART initiation.
  • Prospective Cohort
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1184
February 2015
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18 years (the age of majority in Ethiopia) or older.
  • ART naïve.
  • Eligible for ART according to Ethiopia's National ART guideline criteria.
  • Have received a prescription for ART during the study period.
  • Speak either Oromiffa or Amharic.
  • Special inclusion criteria for case-control sub-analysis:

    • Cases: CD4 count <150 cells/µL (regardless of WHO stage)
    • Controls: CD4 ≥200.

Exclusion Criteria:

  • Overtly cognitively impaired
  • Inability or unwillingness to provide informed consent
  • Actively incarcerated
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT01997359
AAAI1960, 1R01MH089831
No
Batya Elul, Columbia University
Columbia University
National Institute of Mental Health (NIMH)
Principal Investigator: Batya Elul, PhD, MSc ICAP-NY, Columbia University
Columbia University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP