CompletedNot Applicable

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

Malawi1,250 participantsStarted 2020-06-24

Plain-language 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.

Who can participate

Age range25 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Same-day Visual Inspection With Acetic Acid (VIA) Rate

Timeframe: Baseline

Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage

Timeframe: Baseline

High Risk (hr)-Human Papillomavirus (HPV) Positive Rate

Timeframe: Baseline

Trial details

NCT IDNCT04092257

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-28

Results submitted2025-02-14

View on ClinicalTrials.gov More HPV Infection trials

Plain-language summary

Who can participate

Age range25 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.