Principal Investigator: Dr Rebecca Luckett, MD, MPH

Study Objectives:

Primary Objective:

To test the efficacy of single-dose nonavalent HPV vaccination to prevent incident persistent HPV 16/18/31/33/45/52/58 infection among women living with HIV who were vaccinated against HPV 16/18 before HIV diagnosis

Secondary Objectives:

1. To test the efficacy of single-dose nonavalent HPV vaccination to prevent incident persistent HPV 31/33/45/52/58 infection among women living with HIV who were vaccinated against HPV 16/18 before HIV diagnosis.
2. To determine the safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV.

Study Design:

A Prospective, Individual, Double-Blind, Randomized Controlled Study evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received one HPV vaccination prior to HIV diagnosis.

Study population:

Eligible women living with HIV, age 16 years and above who report one to five lifetime partners and single-dose HPV vaccination before HIV diagnosis

Sample size: About 250 participants are expected to be enrolled at the Botswana site. The total global enrolment across three sites (including Rwanda and South Africa) is expected to be 750.

Study duration: 3.5 years

Sponsor: Bill & Melinda Gates Foundation