Clinical trial NCT04286243: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2020-02-26
Enrollment: 8174
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of women who receive cervical cancer screening in Model 2
timeFrame: 12 months after model implementation
measure: Proportion of women who receive family planning services in Model 2
timeFrame: 12 months after model implementation
Secondary outcomes:
measure: Proportion of healthcare workers who report satisfaction with providing cervical cancer services
timeFrame: 12 months after model implementation
measure: Proportion of healthcare workers who report satisfaction with providing family planning services
timeFrame: 12 months after model implementation
measure: Proportion of clients who report satisfaction with cervical cancer services received at study facilities
timeFrame: 12 months after model implementation
measure: Proportion of clients who report satisfaction with family planning services received at study facilities
timeFrame: 12 months after model implementation
measure: Cost of the intervention
timeFrame: 12 months after model implementation
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: UNC Project-Malawi
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer Tang, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.