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
  Purpose

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.


Condition
Human Immunodeficiency Virus (HIV)
Acquired Immune Deficiency Syndrome (AIDS)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1184
Study Start Date: June 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997359

Locations
Ethiopia
Ambo Hospital
Ambo, Ethiopia
Bishoftu Hospital
Bishoftu, Ethiopia
Fitche Hospital
Fitche, Ethiopia
Goba Hospital
Goba, Ethiopia
Nekemte Hospital
Nekemte, Ethiopia
Shashamene Hospital
Shashamene, Ethiopia
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Batya Elul, PhD, MSc ICAP-NY, Columbia University
  More Information

No publications provided

Responsible Party: Batya Elul, Assistant Professor of Clinical Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT01997359     History of Changes
Other Study ID Numbers: AAAI1960, 1R01MH089831
Study First Received: November 8, 2013
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
ART initiation
HIV
AIDS
Ethiopia

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014