Table 2 List of study instruments, data elements and source of information
From: A randomized trial to optimize HIV/TB care in South Africa: design of the Sizanani trial
Data collection instruments | Time of ascertainment | Data collected | Source |
|---|---|---|---|
Pre-screen checkpoints | Day of enrollment | Basic demographic information and eligibility assessment | Subject self report |
Screening and baseline questionnaire | Day of enrollment | Demographic information, emotional health, social support, barriers and competing needs to care | Subject self-report |
Contact information | Day of enrollment | Contact information to reach subject, including preferred language for SMS | Subject self-report |
TB nurse questionnaire | Day of enrollment | TB symptoms and TB treatment history | Subject self-report |
Health system navigator contact log | Day of enrollment and throughout | Perceived barriers to care and strengths to overcome barriers, time spent contacting participants | Medical record, subject self-report |
Participant log | Day of enrollment and throughout | HIV test and CD4 results and retrieval, ART initiation, TB treatment dates and outcomes, date last seen | Medical record, death registry, subject self-report |
9-month follow-up form | Patient telephone interview 9-mo after enrollment | HIV and TB care, demographic and clinical updates, emotional health, social support, and competing needs | Subject self-report |
Study completion form | At 9-mo follow-up | Study endpoint (death, loss to follow-up, completed follow-up) | Medical record, HSN log, death registry |