Multi-level Determinants of Starting ART Late: Aim 3

Human Immunodeficiency Virus (HIV) Clinical Trial

— LSTART  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997359
• Other study ID #: AAAI1960
• Secondary ID: 1R01MH089831
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: December 15, 2014
• Start date: June 2012
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome (AIDS)
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
Ethiopia	Ambo Hospital	Ambo
Ethiopia	Bishoftu Hospital	Bishoftu
Ethiopia	Fitche Hospital	Fitche
Ethiopia	Goba Hospital	Goba
Ethiopia	Nekemte Hospital	Nekemte
Ethiopia	Shashamene Hospital	Shashamene

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Persons Initiating ART Late		12 months	No