Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi

NCT04286243 | Completed

• 2 other identifiers: 19-0638UNCPM 21904
• Study Type: interventional
• Target: 8,174
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Model 1 - Clinic Based Screening

ACTIVE COMPARATOR

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

Other: Clinic-based HPV screening strategy

Model 2 - Community Based Screening

EXPERIMENTAL

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

Other: Community-based HPV screening strategy

Interventions

Community-based HPV screening strategy OTHER

Offering HPV self-collection for cervical cancer screening in the community

Model 2 - Community Based Screening

Clinic-based HPV screening strategy OTHER

Offering HPV self-collection for cervical cancer screening in the clinic

Model 1 - Clinic Based Screening

Eligibility Criteria

• Age: 15 Years - 50 Years
• Gender Eligibility Details: Woman must be between the ages of 15-50 years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Endline Household survey:
• Woman who has had her cervix removed.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

UNC Project-Malawi

Lilongwe, Malawi

Location

Related Publications (1)

• 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.

  PMID: 33879259 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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; Urogenital Diseases; Genital Diseases

Study Officials

• Jennifer Tang, MD, MSCR

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: March 4, 2020
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: November 7, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 6 months of publication for an unlimited period
• Access Criteria: Deidentified data will be publicly available through the DDL. Research datasets may also be made available to Malawian and other international investigators who request access. Requests will be evaluated on a case-by-case basis by the study investigators. Investigators proposing to use the data will be asked to provide approval from an ethical review committee and may be asked to execute a data use/sharing agreement with UNC. Data may be shared electronically via password protected files. All data sharing will abide by rules and/or policies defined by USAID, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as Malawian laws and regulations. Data sharing mechanisms will ensure that the rights and privacy of individuals participating in research will be protected at all times.

Locations

MA (1)