HPV-Based Screen-and-Treat Demonstration Project in Lilongwe

This is a single arm, prospective study of 1,250 women (625 HIV-positive and 625 HIV-negative) enrolled from outpatient clinics that provide sexual and reproductive health (SRH) services and/or HIV care services in Lilongwe, Malawi. The primary objectives of this study are to assess completion of a novel ICC screen-and-treat strategy among HIV-positive women in Lilongwe, Malawi, using self-collected vaginal brush for hr-HPV testing, followed by same-day NIA and thermocoagulation for HPV-positive/NIA-positive/ablation-eligible (by colposcopy) women, and to determine the 24-week efficacy of thermocoagulation among HIV-positive women with CIN2/3. The secondary objective will be to evaluate the performance of the ICC screen-and-treat strategy by estimating overtreatment for women who are HPV-positive/NIA-positive/ablation-eligible, and undertreatment among HPV-positive/NIA-negative women.

Inclusion criteria

• Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening).
• Ability and willingness of participant to provide written informed consent.

Exclusion criteria

• Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia
• Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment)
• Prior HPV vaccination.
• Participants with known allergy to acetic acid.
• Participants with a history of total hysterectomy.
• Participants who are pregnant or plan on becoming pregnant during the study period.
• Participants who are less than 12 weeks postpartum.
• Participants with other illnesses that would limit compliance with study requirements or in the opinion of the investigator or designee, have a problem that would make participation in the study unsafe or complicate interpretation of study findings.