Participants’ HIV needs |
The phase I ICFs described steps consistent with scientific objectives (e.g., discontinuing vaccinations) as well as steps to help participants to access care (e.g., we will counsel you about your HIV infection, we will help you get care and support). The phase IIB ICFs described some steps linked to scientific objectives (e.g., testing how the body controls HIV infection) as well as steps to help participants to access care (e.g., you will be helped to get treatment for your infection). |
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Supplementary material set out steps to help participants to access care (we will refer you to medical professionals, we will tell you where you will be able to receive care and medications, you will get access to ART according to country guidelines). |
Participants’ non-HIV/other needs |
The ICFs for both trials stated that participants must agree to birth control, and outlined some steps for pregnancy (e.g., discontinuing vaccinations if pregnant) but made no statements about how participants would be helped to access services. |
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The ICFs for both trials stated the tests/exams in the HVT might detect health problems and they stated: “You will be helped to get treatment but you will not be provided with treatment for problems unrelated to the study.” |
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Supplementary material set out steps (referral to available counseling, support, medical, and treatment services for illnesses). |
Volunteers |
The ICF for the phase IIB HVT stated that screening tests may show a person cannot join, but no care steps were outlined. |
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The ICF for the phase 1 HVT at one site was the same as above, whereas the other ICF outlined steps (we will tell you about places where you need to get support or medical care). |