NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedNA

Sponsor: UNC Lineberger Comprehensive Cancer Center

Conditions: HPV Infection, Cervical Cancer, HIV Infections

Interventions: VIA and thermocoagulation

Countries: Malawi

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.

Eligibility overview

Sex: FEMALE

Age: 25 Years to 50 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia
2. Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment)
3. Prior HPV vaccination.
4. Participants with known allergy to acetic acid.
5. Participants with a history of total hysterectomy.
6. Participants who are pregnant or plan on becoming pregnant during the study period.
7. Participants who are less than 12 weeks postpartum.
8. 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.

Locations (1)

Lilongwe, Malawi