A Randomized Trial To Compare An HPV Test-And-Treat Strategy To A Cytology-Based Strategy For Prevention Of CIN 2+ In HIV-Infected Women
Inclusion Criteria:
- HIV-1 infection.
- Certain laboratory values obtained within 30 days prior to study entry (more
information can be found in the protocol).
- For candidates suitable for cervical cryotherapy, hr-HPV detected by aHPV within 30
days prior to study entry.
- For women without hr-HPV detected by the aHPV assay, presence of lesions on visual
inspection or HSIL cervical cytology. These participants are not eligible for
randomization to Arms A or B and will be followed in Arm C.
- Suitable candidate for cervical cryotherapy (as defined in the protocol). Unsuitable
participants are not eligible for randomization to Arms A or B and will be followed
in Arm C.
- For participants of reproductive potential, negative pregnancy test within 48 hours
prior to study entry.
- Must agree not to participate in a conception process (e.g. active attempt to get
pregnant or in vitro fertilization), or use at least one reliable contraceptive if
participating in sexual activity, from time of study entry until 12 weeks after study
entry.
- If recently gave birth, must be at least 12 weeks postpartum.
- Ability and willingness of participant or legal guardian/representative to provide
written informed consent.
Exclusion Criteria:
- Current or prior history of cervical, vaginal, or vulvar cancer.
- Prior cervical cryotherapy, LEEP, cervical conization, or total or partial
hysterectomy.
- Cervical, vaginal, or vulvar lesions that are suspicious on clinical exam for cancer.
- Visual evidence of bacterial STIs or suspicion of pelvic inflammatory disease.
- Prior vaccination with an HPV vaccine.
- Hemophilia.
- Currently on anticoagulation therapy other than acetylsalicylic acid.
- Serious illness requiring systemic treatment and/or hospitalization within 21 days
prior to study entry.
- Active drug or alcohol use or dependence or any other condition that, in the opinion
of the site investigator, would interfere with the participant's ability to adhere to
study requirements.