Multi-level Determinants of Starting ART Late: Aim 3

NCT01997359 | Completed

• 2 other identifiers: AAAI19601R01MH089831
• Study Type: observational
• Target: 1,214
• Locations: 1 country
• Sites: 6

Brief 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. 1.Face-to-face interviews with participants using questionnaires
2. 2.Obtaining clinical data from the electronic patient-level database

Conditions

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

Keywords

ART initiation; HIV; AIDS; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Proportion of Persons Initiating ART Late

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Overtly cognitively impaired
• Inability or unwillingness to provide informed consent
• Actively incarcerated

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (6)

Ambo Hospital

Āmbo, Ethiopia

Location

Bishoftu Hospital

Bishoftu, Ethiopia

Location

Fitche Hospital

Fichē, Ethiopia

Location

Goba Hospital

Goba, Ethiopia

Location

Nekemte Hospital

Nekemte, Ethiopia

Location

Shashamene Hospital

Shashamene, Ethiopia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Batya Elul, PhD, MSc

  ICAP-NY, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Epidemiology

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 28, 2013
• Study Start: June 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

ET (6)