Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial

Inclusion Criteria: * ARMS 1-3: Children must be living with HIV. HIV infection documented by positive molecular test or positive serologic test. * ARM 4: Children must be healthy (e.g., without autoimmune disease or cancer) and not infected with HIV * ARMS 1-3: Children must be on a consistent, clinically appropriate combination antiretroviral therapy (ART) regimen for \> 6 months prior to study enrollment * Children must be 9-13 years-old (at or after 9th birthday, prior to 14th birthday) at enrollment. This will allow vaccination of participants within the recommended age range for receipt of HPV vaccination in Peru and Brazil. Only children ages 9-11 (at or after 9th birthday, prior to 12th birthday) will be enrolled into arms 3 and 4 * Clinical laboratory values for children in Arms 1, 2, \& 3 (CLWH) must be as described below: * CD4% \>15% or CD4 counts \>200 cells/ mm3 * VL (\<400 copies/mL) * All female participants must not be pregnant (all females will receive pregnancy tests at all vaccine visits prior to receipt of study vaccine). The effects of Gardasil 9 on the developing human fetus at the recommended therapeutic dose are unknown. If pregnancy is confirmed during the screening process, enrollment will not occur. If pregnancy occurs after the first vaccine dose, additional vaccine doses will not be administered, but the child will remain in study follow-up. * We anticipate that all children will enter the study prior to sexual debut. Sexual debut will be a…