Case Report Forms (CRFs)
Case report forms (CRFs) for TB (link TB form) and HIV (link HIV form), respectively, are completed by the participating sites at enrolment (Baseline) and hereafter at 6, 12 and 24 months using updated, follow-up (FU) CRFs.
For each patient, demographic data, history of previous screening for TB, anti-TB prophylaxis and vaccination, and previous TB disease is recorded. Furthermore, duration of symptoms for the current TB case and the diagnostic procedures for the current TB case is collected including smear microscopy, culture and resistance tests, PCR tests and histology results. Laboratory test results (e.g. hemoglobin, liver enzymes, creatinine), data on anti-TB treatment regimens and anti-TB drug resistance and outcomes of TB disease is also recorded. Data on characterization of the underlying HIV-infection includes information on CD4 cell counts and HIV-RNA measurements, ART history, co-infections (e.g. hepatitis B and C) and AIDS defining diagnoses and malignancies. The collected FU information focuses on reappearance and outcome of TB disease.
Immune Reconstitution Inflammatory Syndrome (IRIS)
For patients suspected of having developed TB IRIS, a specially designed IRIS form (link IRIS form) is completed containing detailed information of the individual IRIS case. The CRF is a modified version of the AIDS Clinical Trials Group (ACTG) IRIS CRF (www.actgnetwork.org).
Causes of Death Form (CoDe form)
For patients who die, a CoDe form (link CoDe form) is completed providing detailed information on the causes of death. For further information, please visit www.cphiv.dk under “CoDe”.
TB and HIV Health Care
Information on HIV and TB health care infrastructure and services at a particular center/country is being collected by using a specially designed questionnaire (link to Survey questionnaire). This survey has been conducted in the early phase of the study period and will be repeated near the end of the study period. Each center is sent a questionnaire to be completed by a health care provider. Information being collected includes the local standards for: TB diagnostics, TB and HIV treatment, availability of 1st and 2nd line TB drugs and ARVs, integration of TB and HIV services, use of Directly Observed Treatment (DOT) strategy, procedures for TB screening among HIV-positive patients and HIV testing among TB patients, use of TB prophylaxis; availability of substitution therapy for IDUs and procedures for laboratory monitoring of TB/HIV patients.
A number of participating sites collect Mycobacterial samples from patients included to the study. These samples are stored at local laboratories and intermittently shipped to the central repository at the coordinating center.
Staff from the coordinating office visits all participating centers to ensure that accurate data is provided.
Protocol (59 kb)
Sample Informed Consent (30 kb)
Protocol – Addendum – Plasma samples
Sample Informed Consent – Plasma Samples
HIV Form - Enrolment NEW! (127 kb)
HIV Form - Instructions (20 kb)
TB Form - Enrolment NEW!(123 kb)
TB Form - Instructions (30 kb)
IRIS form(63 kb)
IRIS Form - Instructions (30 kb)
HIV Form – Instructions -24months
HIV Form – Instructions -12 months
HIV Form – Instructions -6 months
TB Form – Instructions - 12month
TB Form – Instructions - 24 months
TB Form – Instructions – 6month
CoDe Case Report Form (CRF)