HPV vaccine shows promise in cutting cervical lesion risk for HIV-Positive women
NCT ID NCT03284866
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether the HPV vaccine can help prevent high-grade cervical lesions (precancerous growths) in women living with HIV who were already being treated for HPV. About 536 women took part, receiving either the HPV vaccine or a placebo. The goal was to see if the vaccine could lower the chance of these lesions coming back or developing into cancer. Results suggest the vaccine may offer extra protection beyond standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
536 people
The number who actually took part.
- Started
-
Jul 2019
- Finished
-
Aug 2025
- Lead sponsor
-
A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
25 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load, or documentation of receipt of antiretroviral therapy; Note: the term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load * HPV positive by the GeneXpert hrHPV assay with HPV16, HPV 18/45, or HPV31/33/35/52/58 detected; Note: participants who are hrHPV positive with only HPV51/59 or HPV 39/68/56/66 detected are not eligible * Receipt of ART for at least 180 days prior to randomization * Participants of childbearing potential, defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonal contraception), delaying pregnancy for at least 12 months and ideally for the duration of the study; Note: those willing to participate delay pregnancy for at least 6 months, while receiving the recombinant human papillomavirus nonavalent (9vHPV) vaccine (or placebo) * If the participant is of childbearing potential, she should be at least 3 months postpartum * Karnofsky score \>= 70% * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Current sexually transmitted infection (STI) requiring treatment (women may participate after adequate treatment, at the discretion of the treating provider) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gardasil or Gardasil 9 * Uncontrolled intercurrent illness that would limit compliance with study requirements * Prior hysterectomy with removal of the cervix * Prior treatment for cervical HSIL * Prior history of cervical, vulvar, or vaginal cancer * Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless biopsies show no invasive cancer * Known bleeding diathesis * Prior HPV vaccination * Current or planned use of anticoagulants other than aspirin or non-steroidal anti-inflammatory agents
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for AIDS-related human papillomavirus infection are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
African Cancer Institute at Stellenbosch
Cape Town, South Africa
-
Moi University School of Medicine
Eldoret, Kenya
-
UNC Project Malawi
Lilongwe, Malawi
-
Uganda Cancer Institute
Kampala, Uganda
-
University of Zimbabwe
Harare, Zimbabwe
-
University of the Witwatersrand
Johannesburg, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Four weeks vs twelve weeks: can a shorter TB prevention course work?
- Can a phone app keep young people with HIV engaged in care?
- Massive Real-World database aims to map how chronic diseases interact
- How do HIV drugs behave when kidneys fail? study measures blood levels
- Can HIV-Positive mothers breastfeed without passing the virus to their babies?