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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04092257
Recruitment Status : Active, not recruiting
First Posted : September 17, 2019
Last Update Posted : November 30, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
HPV Infection Cervical Cancer HIV Infections Procedure: VIA and thermocoagulation Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Malawi
University of North Carolina (UNC) Project-Malawi
Lilongwe, Malawi
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Lameck Chinula, MD University of North Carolina
More Information
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04092257    
Other Study ID Numbers: LCCC 1905
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Visual inspection with acetic acid (VIA)
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Papillomavirus Infections
Uterine Cervical Neoplasms
Disease Attributes
Pathologic Processes
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Virus Diseases
Genital Diseases
Urogenital Diseases
Uterine Neoplasms
 Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
DNA Virus Infections
Tumor Virus Infections