HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
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|ClinicalTrials.gov Identifier: NCT04092257|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2019
Last Update Posted : November 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|HPV Infection Cervical Cancer HIV Infections||Procedure: VIA and thermocoagulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for HIV-infected Women in Lilongwe Malawi|
|Actual Study Start Date :||June 24, 2020|
|Estimated Primary Completion Date :||February 28, 2024|
|Estimated Study Completion Date :||February 28, 2024|
Experimental: VIA and thermocoagulation
Participants will undergo same day VIA and thermocoagulation
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.
- Number (and %) of women with HPV-positive results who receive VIA same-day [ Time Frame: 2 years ]We will calculate the proportion with corresponding 95% Confidence Interval (CIs) of women who are HPV positive who have VIA performed same-day, and
- Number (and %) of women with VIA positive results and are ablation-eligible by colposcopy who receive thermocoagulation same-day [ Time Frame: 2 years ]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.
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|Ages Eligible for Study:||25 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening).
- Females with confirmed HIV-1 infection. FDA-approved testing methods should be used when possible.
- Ability and willingness of participant to provide written informed consent.
- Current or prior history of cervical, vaginal or vulvar cancer or dysplasia
- Current symptomatic sexual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092257
|University of North Carolina (UNC) Project-Malawi|
|Principal Investigator:||Lameck Chinula, MD||University of North Carolina|
|Responsible Party:||UNC Lineberger Comprehensive Cancer Center|
|Other Study ID Numbers:||
R21CA236770 ( U.S. NIH Grant/Contract )
AID-OAA-A-11-00012 ( Other Grant/Funding Number: USAID/NAS )
|First Posted:||September 17, 2019 Key Record Dates|
|Last Update Posted:||November 30, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Visual inspection with acetic acid (VIA)
Uterine Cervical Neoplasms
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Neoplasms, Female
Neoplasms by Site
Uterine Cervical Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
DNA Virus Infections
Tumor Virus Infections