HIV+ Reporting Requirements for Research Involving HIV Testing

Overview

The California Code of Regulations (17 CCR 2643.10) requires that positive cases of HIV be reported to the local health authority. Studies that involve HIV testing need to follow the reporting requirements, use a secure method of sharing test results with the local health authority, and ensure that the study consent forms include the most updated IRB template language regarding the reporting requirements.

See the letter from California Department of Public Health for background and reporting requirements.

This policy applies to studies involve HIV testing for research purposes—even if only for initial screening.

2020 Policy Change & Impact on Studies Involving HIV Testing for Research Purposes

There was a policy change in 2020 that may impact your study consent form/s and your reporting procedures. Previously, only new HIV cases had to be reported to the county health department. The policy has been updated to require that all HIV-related test results for positive cases be reported, regardless of previous diagnosis. The required report includes:

  • HIV screening (e.g. antigen, antibody, nucleic acid)
  • CD4+ count (or T-cell count)
  • viral load
  • viral genotype.

Note: The participant’s Personally Identifiable Information (PII) must be reported along with the results.

Consent forms for studies that are open to enrollment and involve HIV testing for research purposes must include language specifying that all positive HIV test results are reportable. Because of the 2020 policy change, some existing consent forms may contain outdated language regarding HIV reporting requirements (i.e., indicating that only new positive results must be reported).

Please ensure compliance with the policy by doing the following:

  1. New studies: Use the current consent form language on HIV reporting, accessible from the “Biomedical and Cancer” consent form template.
  2. Approved studies that are open to enrollment: Compare your approved consent form with the most recently updated language on HIV reporting, accessible from the “Biomedical and Cancer” consent form template. If your consent form has outdated HIV reporting language, or if it does not have any HIV reporting language but needs it, please submit a modification with an updated consent form. 

Policy Exceptions

Per 17 CCR 2643.20, HIV reporting is not required in the following scenarios:

  1. HIV testing is performed by Alternative Testing Sites, other anonymous or unlinked HIV testing programs, blood banks, or plasma centers
  2. Blinded and/or unlinked seroprevalence studies 

How to submit HIV-positive test results to the SFDPH

SFDPH has created a set of data specifications they would like UCSF studies to follow when reporting data to them. Please use the "UCSF Research Studies Lab Data Specifications" spreadsheets for this purpose.

You can securely share this sensitive data with the SFDPH through a platform called MyTransfer, which is available through the Research Analysis Environment (RAE). Follow these instructions for setting up your RAE site:

  1. Go to https://ucsf.service-now.com/ucsfit and search for “RAE – Research Analysis Environment Request (formerly MyResearch)”.  You may be prompted to log into MyAccess.
  2. Fill out the request form. Under Account Information, indicate that you are requesting a “New RAE site (No storage limit…)”
  3. Add the users who will have access to this site. This should be limited to the PI and any individuals who will send and receive the reportable data. Click the Add button, then search for the user’s name and fill out their contact details. If their name does not appear in the drop-down menu, check the box that says, “Check this box if you cannot find the user name…” and then fill out their name and contact details.

Add the two SFDPH team members who will receive the HIV- related lab data from UCSF:

  1. Once the RAE request form is submitted, the individuals listed on it will receive an email with account setup instructions.

If you need technical help with setting up or using your RAE site, please contact UCSF IT.

Last updated: September 27, 2023