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

• ClinicalTrials.gov Identifier: NCT04286243
• Recruitment Status: Suspended
• First Posted: February 26, 2020
• Last Update Posted: May 12, 2020
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: United States Agency for International Development (USAID)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer	Other: Community-based HPV screening strategy; Other: Clinic-based HPV screening strategy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 9200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

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.

• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: UNCPM 21904 - Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi: a Cluster Randomized Trial
• Actual Study Start Date: March 4, 2020
• Estimated Primary Completion Date: November 2021
• Estimated Study Completion Date: November 2021

Arms and Interventions

Arm	Intervention/treatment
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	Other: 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	Other: Community-based HPV screening strategy; Offering HPV self-collection for cervical cancer screening in the community

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

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 50 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: 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.

Contacts and Locations

Locations

Malawi

UNC Project-Malawi

Lilongwe, Malawi

Sponsors and Collaborators

University of North Carolina, Chapel Hill

United States Agency for International Development (USAID)

Investigators

• Principal Investigator: Jennifer Tang, MD, MSCR; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04286243
• Other Study ID Numbers: 19-0638; UNCPM 21904 ( Other Identifier: University of North Carolina at Chapel Hill )
• First Posted: February 26, 2020
• Last Update Posted: May 12, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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 Materials: 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

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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female