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Table 1 SiVETs and non-SiVETs cohorts’ participant eligibility criteria

From: Comparison of retention in observational cohorts and nested simulated HIV vaccine efficacy trials in the key populations in Uganda

SiVET cohorts

non-SiVET cohorts

Inclusion

• At least 3 and no more than 18 months of follow up in the OBC1 or OBC2

• HIV-1 negative and willing to undergo HIV testing

• Aged ≥18 years and ≤ 49 years

• Able and willing to provide written informed consent

• Able and willing to provide adequate locator information including physical address

• Willing and able to return for follow-up clinic visits

• Intending to reside in study area for at least one year

Females only

• Willing to undergo pregnancy testing

• Not breastfeeding and no intent for pregnancy in the next one year

• Willing to use effective contraception during the study and at least 3 months after the last vaccination

Inclusion

• At least 3 months and no more than 18 months of follow up in OBC1 or OBC2

• Still in follow up in the OBCs

• HIV-1 negative and willing to undergo HIV testing

Exclusion

Exclusion

• HIV positive

• History of severe allergic reaction to any substance

• An acute or chronic illness

• Contraindication for Hepatitis B vaccine

• Participation in another clinical trial

• Hepatitis B exposure, as assessed by surface antigen (HBsAg) and core antibody (HBcAb) titers (only SiVET2)

• Not willing to provide written consent

HIV positive

  1. SiVET- Simulated Vaccine Efficacy Trial, OBC- Observational cohort