Table 1 Study procedures

Timepoint**

-t₂

-t₁

0

t₁

(m1)

t₂

(m3)

t₃

(m6)

t₄

(m9)

t₅

(m12)

t₆

(m15)

t₇

(m18)

t₈

(m21)

t₉

(m24)

t₁₀

(m27)

t₁₁

(m30)

t₁₂

(m33)

t₁₃

(m36)

t₁₄

(m37)

Screening

 Eligibility screen

X

 Informed consent/assent

X

enrolment:

 Eligibility screen

X

 Informed consent/assent

X

 Demographics & enrollment questionnaire

X

Randomization

X

 Masked vaccination

X

Follow-up

 Follow-up questionnaire

X^a

X

X

X

X

X

X

X

X

X

X

X

 Record for post vaccination AEs

X^a,e

X^e

Specimen collection

 External genital swab for HPV DNA

X

 Self-collected vaginal swab for HPV DNA

X

 Cervical swab for HPV DNA

X

X^f

X^f

X^f

X^f

X^f

X^f

 Provider-collected vaginal swab for HPV DNA

X

X^f

X^f

X^f

X^f

X^f

X^f

 Serum for HPV Antibodies (5 mL whole blood)

X

X^a,c

X

X^c

X

 Collect PBMC for B cell study (40 mL)

X^a,d

X^d

X^b,d

 Pap smear

X

X

 Rapid HIV test- finger prick or arm (2 mL whole blood)

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Urine for pregnancy test (20 mL)

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 STI testing (cervical/vaginal swab) for CT/GC NAATS testing^g

X

X

X

X

X

X

X

 STI testing (cervical/vaginal swab) for T. Vaginalis NAATS testing^g

X

X

 STI testing (cotton swab) for Bacterial Vaginosis^g

X

X

X

X

X

X

X

 STI testing (5 mL whole blood) Serum for syphilis^g

X

X

X

X

X

X

X

 STI testing (5 mL whole blood) serum for HSV-2^g

X

X

Assays

 HPV DNA

X

X

X

X

X

X

X

X

 HPV Antibody Luminex

X

X^a,c

X

X^c

X

 Memory B cell

X^a,d

X

X^b,d

 Pap smear

X

X

 HIV rapid

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 Pregnancy rapid

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 CT/GC

X

X

X

X

X

X

X

T . Vaginalis

X

X

 Bacterial Vaginosis

X

X

X

X

X

X

X

 Syphilis

X

X

X

X

X

X

X

 HSV-2

X

X

Standard procedures

 Review medical history

X

X^a

X

X

X

X

X

X

X

X

X

X

X

X

 Offer contraception

X

X

X^a

X

X

X

X

X

X

X

X

X

X

X

X

X

 Offer PrEP

X

X

X^a

X

X

X

X

X

X

X

X

X

X

X

X

X

 Record AE/SAE

X

X

X^a

X

X

X

X

X

X

X

X

X

X

X

X

X