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Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.

Active Not RecruitingPhase 4

Sponsor: Massachusetts General Hospital

Conditions: Human Papilloma Virus, Hiv

Interventions: GARDASIL®9, Menveo®/Menactra®

Countries: Botswana, Rwanda, South Africa

The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received prior HPV vaccination.

Eligibility overview

Sex: FEMALE

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Age 16 years and above on the day of signing the ICF
2. Living with HIV with confirmed test results or clinic records
3. History of receiving HPV vaccine
4. Self-reported sexually active in the last six months
5. Lives within the study area and willing to provide updated locator information over the course of the study
6. Does not have an autoimmune, degenerative, or genetic disease
7. Does not have known advanced HIV (as per stage IV WHO clinical staging criteria for HIV)
8. No other Investigator-determined factor would limit participation in the trial
9. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
10. The participant has a cervix

Exclusion Criteria:

1. Anyone with cervical abnormality on examination
2. Anyone with an allergy to vaccine components or yeast

Locations (3)

Gaborone, Botswana
Kigali, Kigali, Rwanda
Johannesburg, Gauteng, South Africa