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History of Changes for Study: NCT04286243
Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi
Latest version (submitted September 22, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 24, 2020 None (earliest Version on record)
2 March 23, 2020 Recruitment Status, Study Status and Contacts/Locations
3 May 8, 2020 Recruitment Status, Study Status and Contacts/Locations
4 September 15, 2020 Recruitment Status, Study Status and Contacts/Locations
5 October 7, 2021 Study Status
6 January 20, 2022 Recruitment Status, Study Status and Contacts/Locations
7 May 20, 2022 Recruitment Status, Study Status and Study Design
8 September 22, 2022 Document Section and Study Status
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Study NCT04286243
Submitted Date:  February 24, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 19-0638
Brief Title: Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi
Official Title: UNCPM 21904 - Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi: a Cluster Randomized Trial
Secondary IDs: UNCPM 21904 [University of North Carolina at Chapel Hill]
Open or close this module Study Status
Record Verification: February 2020
Overall Status: Not yet recruiting
Study Start: March 4, 2020
Primary Completion: November 2021 [Anticipated]
Study Completion: November 2021 [Anticipated]
First Submitted: February 24, 2020
First Submitted that
Met QC Criteria:
February 24, 2020
First Posted: February 26, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
February 24, 2020
Last Update Posted: February 26, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of North Carolina, Chapel Hill
Responsible Party: Sponsor
Collaborators: United States Agency for International Development (USAID)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:

Cervical cancer is largely preventable through screening and preventive therapy. This is a cluster randomized trial that will integrate a novel cervical cancer screen-and-treat algorithm into voluntary family planning (VFP) services via two different models aimed at reducing barriers to screening and treatment in resource limited settings. 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 visual inspection with acetic acid (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. Participants will be recruited from 16 high HIV-prevalence clinics in either Lilongwe in the Central Region or Zomba in the Southern Region. The broad objective of the project is to compare the effectiveness and budget impact of these two models for averting potential cervical cancer cases and to evaluate the implementation and acceptability of the models in multiple different health care facility settings.

A systematic Implementation Evaluation will be conducted throughout implementation of the assigned models at the study health facilities to determine the success/failure in the delivery of intervention packages. The study team will employ the following mixed method data collection assessments:

  • In-Depth Interviews with purposively selected healthcare facility staff and clients in the sampled facilities (N = approximately 60)
  • Focus group discussions (FGDs) with purposively selected in-clinic services providers and HSAs (N = approximately 160)
  • Structured weekly observations of service delivery by clinical mentors using an observation checklist, to observe providers and laboratorians adherence to standards, guidelines and intervention protocols
  • Aggregate collection of routine quantitative service utilization data from adapted family planning and cervical cancer screening registers
  • Implementation of assessment tools to assess changes in service providers' workload
  • Client Exit Surveys with women in the catchment areas of the targeted facilities who received or declined family planning and/or cervical cancer screening services at the facility or in the community (N= approximately 1,000)
  • Time and motion studies to observe visits and staff time spent on counseling, screening and treatment procedures, and managing and testing specimens.

Finally, an Endline Household Survey will be completed among a random sample of women selected from all of the facilities' catchment areas (N= approximately 8,000). This survey will ask questions about basic demographic information, reproductive health information, HIV status, distance to the nearest health facility, prior VFP use, VFP use during project implementation, prior cervical cancer screening and preventive therapy (CCSPT) services received, and any CCSPT services received during project implementation.

Open or close this module Conditions
Conditions: Cervical Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Health Services Research
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment

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.

Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 9200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Model 1 - Clinic Based Screening
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
Clinic-based HPV screening strategy
Offering HPV self-collection for cervical cancer screening in the clinic
Experimental: Model 2 - Community Based Screening
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
Community-based HPV screening strategy
Offering HPV self-collection for cervical cancer screening in the community
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of women who receive cervical cancer screening in Model 2
[ Time Frame: 12 months after model implementation ]

Effectiveness of community-based cervical cancer screening as measured through Endline Household Surveys
2. Proportion of women who receive family planning services in Model 2
[ Time Frame: 12 months after model implementation ]

Effectiveness of integrating community-based cervical cancer screening into family planning services as measured through Endline Household Surveys
Secondary Outcome Measures:
1. Proportion of healthcare workers who report satisfaction with providing cervical cancer services
[ Time Frame: 12 months after model implementation ]

Acceptability and feasibility of service provision as measured through routine assessments
2. Proportion of healthcare workers who report satisfaction with providing family planning services
[ Time Frame: 12 months after model implementation ]

Acceptability and feasibility of service provision as measured through routine assessments
3. Proportion of clients who report satisfaction with cervical cancer services received at study facilities
[ Time Frame: 12 months after model implementation ]

Acceptability and feasibility of cervical cancer screening and preventive therapy as measured through client exit surveys
4. Proportion of clients who report satisfaction with family planning services received at study facilities
[ Time Frame: 12 months after model implementation ]

Acceptability of family planning services as measured through client exit surveys
5. Cost of the intervention
[ Time Frame: 12 months after model implementation ]

The cost per client of adding cervical cancer screening and preventive therapy to voluntary family planning services in each model as measured through routine assessments and client exit surveys
Open or close this module Eligibility
Minimum Age: 15 Years
Maximum Age: 50 Years
Sex: Female
Gender Based: Yes
Woman must be between the ages of 15-50 years
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

Health care providers In-Depth Interviews (IDIs) and Focus Group Discussions:

  • Health care staff member must be currently working at one of the 16 health facilities selected for the study.

Client In-Depth Interviews:

  • Woman must have participated in cervical cancer screening via HPV self-sampling through one of the 16 health facilities during the study period.

Client Exit Surveys:

  • Woman who received or declined VFP and/or CCS services in the catchment area of the targeted facilities.

Endline Household survey:

  • Woman must be between the ages of 15-50 years.

Exclusion Criteria:

Endline Household survey:

  • Woman who has had her cervix removed.
Open or close this module Contacts/Locations
Central Contact Person: Jennifer Tang, MD, MSCR
Telephone: (919) 843-9546
Email: jennifer_tang@med.unc.edu
Central Contact Backup: Lameck Chinula, MBBS, MMED
Email: lameck_chinula@med.unc.edu
Study Officials: Jennifer Tang, MD, MSCR
Principal Investigator
University of North Carolina, Chapel Hill
Locations: Malawi
UNC Project-Malawi
Lilongwe, Malawi
Contact:Contact: Lameck Chinula, MBBS, MMED
Open or close this module IPDSharing
Plan to Share IPD: Yes
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).
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame:
Data will be available within 6 months of publication for an unlimited period
Access Criteria:
URL:
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services