Table 1.
Key Questions
| Appropriateness of the study |
| Is the research question of sufficient importance that potential increased risks to participants are acceptable? |
| Should the study be implemented during the SARS-CoV-2 pandemic? |
| Study design |
| Are there structural changes to the study that might minimize risks to participants? |
| Should exclusion criteria be updated to minimize participant risk? |
| What should be the frequency of SARS-CoV-2 testing during the study? |
| What should be the frequency of HIV viral load monitoring during the ATI? |
| What should be the frequency of CD4 + T-cell monitoring during the ATI? |
| Informed consent and participant education |
| How should study risks related to SARS-CoV-2 be described in the informed consent form? |
| How can the study team ensure that participants are adequately informed and counseled about SARS-CoV-2–related risks during the study? |
| How should the study team account for emerging scientific information around SARS-CoV-2, COVID-19, and HIV, and evolving standards of prevention and treatment during the study? |
| Is there an independent clinician or health advisor with whom the participant can engage throughout the study? |
| Study implementation |
| How can risks related to the frequency of in-person trial visits be minimized? |
| What should SARS-CoV-2 standard-of-prevention precautions look like? |
| Analytical treatment interruption |
| What additional risk mitigation measures should be implemented around the ATI? |
| SARS-CoV-2 contingencies |
| What should happen if a participant has COVID-19–related symptoms? |
| What should happen if a participant tests positive for SARS-CoV-2 during the study? |
| What would happen if the local SARS-CoV-2 epidemic worsens? |
| How can an independent body such as a community advisory board or safety monitoring committee be engaged to advise the study team during the study? |
| How would the rollout of multiple SARS-CoV-2 vaccine trials or the potential implementation of an efficacious and approved vaccine be handled during the study? |
Questions are for consideration in the implementation of HIV cure studies during the SARS-CoV-2 pandemic.
Abbreviations: ATI, analytic treatment interruption; COVID-19, coronavirus disease 2019; HIV, human immunodeficiency virus; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.