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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04092257
Other study ID # LCCC 1905
Secondary ID R21CA236770AID-O
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 24, 2020
Est. completion date February 28, 2025

Study information

Verified date February 2024
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a single arm, prospective study of 625 HIV-positive women attending ART clinics 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 VIA and thermocoagulation for HPV-positive/VIA-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/VIA-positive/ablation-eligible, and undertreatment among HPV-positive/VIA-negative women.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1250
Est. completion date February 28, 2025
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 50 Years
Eligibility 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. Females with confirmed HIV-1 infection. FDA-approved testing methods should be used when possible. 3. 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 sexual 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.

Study Design


Intervention

Procedure:
VIA and thermocoagulation
Participants will self-collect a vaginal brush for hr-HPV testing. HPV-positive women and every 10th consecutive HPV-negative woman will complete same-day VIA with colposcopically-directed cervical biopsy and ECC (if lesion seen), and thermocoagulation if ablation-eligible by colposcopy. If no lesion is seen on colposcopy, the woman will have a cervical pap smear and ECC collected, and no thermocoagulation will be performed. Finally, women who are suspicious for cancer at VIA will undergo colposcopically-directed cervical biopsies.

Locations

Country Name City State
Malawi University of North Carolina (UNC) Project-Malawi Lilongwe

Sponsors (3)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI), United States Agency for International Development (USAID)

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number (and %) of women with HPV-positive results who receive VIA same-day We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are HPV positive who have VIA performed same-day, and 2 years
Primary Number (and %) of women with VIA positive results and are ablation-eligible by colposcopy who receive thermocoagulation same-day We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are VIA positive/ablation-eligible (by colposcopy) who have thermocoagulation performed the same-day. 2 years
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