UNCPM 21904 - Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi: a Cluster Randomized Trial
Sponsor study identifier
Secondary identifiers
OTHER · University of North Carolina at Chapel Hill
interventional
8,174
1 country
1
Study Start
March 4, 2020
Actual (reported)Primary Completion
December 18, 2021
Actual (reported)Study Completion
December 18, 2021
Actual (reported)The purpose of the study is to determine the acceptability, appropriateness, and feasibility of implementing new strategies to screen and treat eligible women for cervical cancer through a cluster randomized trial of two different models. Both models offer the same screening and treatment algorithm, but one will be based in Voluntary Family Planning (VFP) or other clinics and the second will be based in the community. Participants will be recruited from two districts in Malawi with the highest HIV prevalence in the country: Lilongwe in the Central Region and Zomba in the Southern Region.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 18, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2020
Actual (reported)February 26, 2020
Actual (reported)March 4, 2020
Actual (reported)December 18, 2021
Actual (reported)December 18, 2021
Actual (reported)Proportion of women who receive cervical cancer screening in Model 2
Effectiveness of community-based cervical cancer screening as measured through Endline Household Surveys
12 months after model implementation
Proportion of women who receive family planning services in Model 2
Effectiveness of integrating community-based cervical cancer screening into family planning services as measured through Endline Household Surveys
12 months after model implementation
Proportion of healthcare workers who report satisfaction with providing cervical cancer services
12 months after model implementation
Proportion of healthcare workers who report satisfaction with providing family planning services
12 months after model implementation
Proportion of clients who report satisfaction with cervical cancer services received at study facilities
12 months after model implementation
Proportion of clients who report satisfaction with family planning services received at study facilities
12 months after model implementation
Cost of the intervention
12 months after model implementation
Model 1 involves: 1) cervico-vaginal self-sampling for high-risk HPV (hr-HPV) while waiting for appointments at the VFP clinic or other clinics, 2) same-day VIA for those women found to be hr-HPV-positive by rapid GeneXpert HPV testing, and 3) same-day thermocoagulation treatment for HPV-positive women who are eligible for ablative therapy by VIA
Model 2 will offer women the same services as in Model 1, but they will also be given the option to perform cervico-vaginal self-sampling in the community, via Heath Surveillance Assistants (HSAs) who will bring their HPV sample to the clinic and notify them to return to the clinic for VIA and possible same-day thermocoagulation if their hr-HPV test is positive
Offering HPV self-collection for cervical cancer screening in the community
Offering HPV self-collection for cervical cancer screening in the clinic
UNC Project-Malawi
Lilongwe, Malawi
Tang JH, Smith JS, McGue S, Gadama L, Mwapasa V, Chipeta E, Chinkhumba J, Schouten E, Ngwira B, Barnabas R, Matoga M, Chagomerana M, Chinula L. Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: protocol for a cluster randomized feasibility trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):98. doi: 10.1186/s40814-021-00839-7.
Jennifer Tang, MD, MSCR
University of North Carolina, Chapel Hill
8,174 participants (actual enrollment reported by the registry).
First Submitted
February 24, 2020
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
February 26, 2020
Study Start
March 4, 2020
Actual (reported)Primary Completion
December 18, 2021
Actual (reported)Study Completion
December 18, 2021
Actual (reported)Last Updated
November 7, 2023
Record last verified: 2022-05
Research data that documents, supports, and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Access to databases will be available for educational, research, and non-profit purposes. All data to be shared will be stripped of any potentially identifying information. Data will be made available through USAID's Data Development Library (DDL).
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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