Table 1.
Study procedures
| Study period | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening | Enrollment | Allocation | Post-allocation | Close-out | |||||||||||||
| 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 | Xa | X | X | X | X | X | X | X | X | X | X | X | |||||
| Record for post vaccination AEs | Xa,e | Xe | |||||||||||||||
| Specimen collection | |||||||||||||||||
| External genital swab for HPV DNA | X | ||||||||||||||||
| Self-collected vaginal swab for HPV DNA | X | ||||||||||||||||
| Cervical swab for HPV DNA | X | Xf | Xf | Xf | Xf | Xf | Xf | ||||||||||
| Provider-collected vaginal swab for HPV DNA | X | Xf | Xf | Xf | Xf | Xf | Xf | ||||||||||
| Serum for HPV Antibodies (5 mL whole blood) | X | Xa,c | X | Xc | X | ||||||||||||
| Collect PBMC for B cell study (40 mL) | Xa,d | Xd | Xb,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 testingg | X | X | X | X | X | X | X | ||||||||||
| STI testing (cervical/vaginal swab) for T. Vaginalis NAATS testingg | X | X | |||||||||||||||
| STI testing (cotton swab) for Bacterial Vaginosisg | X | X | X | X | X | X | X | ||||||||||
| STI testing (5 mL whole blood) Serum for syphilisg | X | X | X | X | X | X | X | ||||||||||
| STI testing (5 mL whole blood) serum for HSV-2g | X | X | |||||||||||||||
| Assays | |||||||||||||||||
| HPV DNA | X | X | X | X | X | X | X | X | |||||||||
| HPV Antibody Luminex | X | Xa,c | X | Xc | X | ||||||||||||
| Memory B cell | Xa,d | X | Xb,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 | Xa | X | X | X | X | X | X | X | X | X | X | X | X | |||
| Offer contraception | X | X | Xa | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Offer PrEP | X | X | Xa | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Record AE/SAE | X | X | Xa | X | X | X | X | X | X | X | X | X | X | X | X | X | |