The Clinical Research Forms (CRFs) below were used to collect volunteer medical information during Protocol C clinical assessments. Click on the CRF to view or download.
CRF name |
|
Description |
Acute Retroviral Syndrome Assessment |
Administered once, typically at enrollment, to evaluate signs and symptoms of acute retroviral syndrome |
|
Anti-Retroviral Medications Log |
A log form to describe any antiretroviral medications taken during the study (i.e., completed and/or updated and entered with any changes to medications) |
|
Volunteer Receipt Form |
A form used to track volunteers who moved from one study site to another (a rare event) |
|
Concomitant Medications |
A log form to describe any medications except ART taken during the study (i.e., completed and/or updated and entered with any changes to medications) |
|
Care and Treatment Referral |
A form used to track referrals for care and/or treatment not provided by the study staff |
|
Baseline Demographics |
A form administered at enrollment to record basic demographic details |
|
Death Report |
A form used to record details of death, for those volunteers who died while on study |
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Volunteer Status Form |
A form completed when the volunteer went off study, to describe final study status and/or reason for going off study |
|
HIV Disease Assessment |
A form used to describe any HIV or AIDS-associated illnesses while on study |
|
Hematology, Lymphocyte Subset, and Serum Chemistry |
A form completed at all regular study visits for hematology, CD4 counts and chemistry |
|
HIV Testing and Exposure History (page 1) |
Administered once, typically at enrollment, to describe HIV test history and determine the estimated date of HIV infection |
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HIV Testing and Exposure History (page 2) |
Administered once, typically at enrollment, to describe HIV test history and determine the estimated date of HIV infection |
|
Laboratory Testing: HIV, Syphilis, and Pregnancy |
A form completed as needed for syphilis (annually), HIV (recorded at baseline, confirmed if enrolled pre-seroconversion), and pregnancy (women, quarterly) |
|
SMARTube Results (Rustenburg only) |
Used for a sub study conducted for a short period at one participating research center |
|
Medical History Log Baseline and Interim History |
A log form to describe medical history (enrollment) and updated with any changes to medical history (i.e., volunteer reports new medical complaint not documented on HDA-1) |
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Missed Visit Form |
Completed at every missed visit |
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Physical Exam Form |
Completed at every regular visit, body systems review completed if indicated (i.e., volunteer complaint) |
|
Partner Inclusion/ Exclusion Criteria |
Inclusion/exclusion criteria for suspected transmitting partners, completed at enrollment (older version) |
|
Partner Inclusion/ Exclusion Criteria |
Inclusion/exclusion criteria for suspected transmitting partners, completed at enrollment (newer version) |
|
Pregnancy Outcome |
Birth outcomes for pregnant volunteers |
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EIR Registration / De-registration Form |
Documenting enrollment for certain volunteers enrolled early (within 45 days of estimated date of HIV infection) as part of an Early Immune Response (EIR) sub study |
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Urinalysis Form |
Data on urinalysis, collected at enrollment |
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Volunteer Inclusion/ Exclusion Criteria |
Inclusion/exclusion criteria for volunteers with incident HIV infection, completed at enrollment (older version) |
|
Volunteer Inclusion/ Exclusion Criteria |
Inclusion/exclusion criteria for volunteers with incident HIV infection, completed at enrollment (newer version) |
|
Visit/Contact Documentation Form |
Collected at every visit (regular and interim) to document study contact |