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

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ClinicalTrials.gov Identifier: NCT04092257
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : August 24, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE September 13, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date August 24, 2020
Actual Study Start Date  ICMJE June 24, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
Official Title  ICMJE A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for HIV-infected Women in Lilongwe Malawi
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HPV Infection
  • Cervical Cancer
  • HIV Infections
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: VIA and thermocoagulation
Participants will undergo same day VIA and thermocoagulation
Intervention: Procedure: VIA and thermocoagulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
625
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lameck Chinula, MD 1 (919) 962-0760 lameck_chinula@med.unc.edu
Contact: Jennifer Tang, MD (919) 966-2281 jennifer_tang@med.unc.edu
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04092257
Other Study ID Numbers  ICMJE LCCC 1905
R21CA236770 ( U.S. NIH Grant/Contract )
AID-OAA-A-11-00012 ( Other Grant/Funding Number: USAID/NAS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor  ICMJE UNC Lineberger Comprehensive Cancer Center
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • United States Agency for International Development (USAID)
Investigators  ICMJE
Principal Investigator: Lameck Chinula, MD University of North Carolina
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP