Multi-level Determinants of Starting ART Late: Aim 3

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01997359
• Date of registration: 08/11/2013
• Prospective Registration: No
• Primary sponsor: Columbia University
• Public title: Multi-level Determinants of Starting ART Late: Aim 3 LSTART
• Scientific 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
• Date of first enrolment: June 2012
• Target sample size: 1214
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01997359
• Study type: Observational [Patient Registry]
• Study design: Observational Model: Case Control, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Ethiopia

Contacts

• Name: Batya Elul, PhD, MSc
• Affiliation: ICAP-NY, Columbia University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Human Immunodeficiency Virus (HIV)

Acquired Immune Deficiency Syndrome (AIDS)

Primary Outcome(s)

Proportion of Persons Initiating ART Late [Time Frame: 12 months]

Secondary ID(s)

AAAI1960

1R01MH089831

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Mental Health (NIMH)