A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for Women in Lilongwe Malawi
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HPV Infection
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 1250
- Locations
- 1
- Primary Endpoint
- Same-day Visual Inspection With Acetic Acid (VIA) Rate
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) rapid testing of self-collected vaginal brush for primary high risk (hr)-human papillomavirus (HPV), 2) same-day visual inspection with acetic acid (VIA) for women who are hr-HPV positive, and 3) thermocoagulation for VIA positive/ablation-eligible (by cervical colposcopy) women.
Detailed Description
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Same-day Visual Inspection With Acetic Acid (VIA) Rate
Time Frame: Baseline
The proportion of women who were HPV-positive and underwent same-day VIA following self-collected vaginal sampling was assessed, including both HIV-positive and HIV-negative participants. As per the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day VIA completion by HIV status.
Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage
Time Frame: Baseline
Among women who tested HPV-positive through primary screening, those eligible for thermocoagulation by colposcopy triage received thermocoagulation treatment on the same day as self-collection. As specified in the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day colposcopy completion by HIV status.
High Risk (hr)-Human Papillomavirus (HPV) Positive Rate
Time Frame: Baseline
The proportion of women who tested High risk (hr)-human papillomavirus (HPV) positive on a self-collected vaginal brush among enrolled participants.
Secondary Outcomes
- HPV Screen-triage-treat Algorithm for Cervical Cancer Screening(Up to 24 weeks)