Cervical CancerNCT04286243
Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi
A study testing Community-based HPV screening strategy and Clinic-based HPV screening strategy in people with Cervical Cancer, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Community-based HPV screening strategy and Clinic-based HPV screening strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,174 participants
- Where
- 1 siteMalawi
- Study dates
- 4 Mar 2020to 18 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Endline Household survey:
- Woman who has had her cervix removed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: UNCPM 21904 - Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi: a Cluster Randomized Trial
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Community-based HPV screening strategy, Clinic-based HPV screening strategy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based HPV screening strategyOther
Offering HPV self-collection for cervical cancer screening in the community
Clinic-based HPV screening strategyOther
Offering HPV self-collection for cervical cancer screening in the clinic
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Community-based HPV screening strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who receive cervical cancer screening in Model 2
Effectiveness of community-based cervical cancer screening as measured through Endline Household Surveys
Measured: 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
Measured: 12 months after model implementation
Secondary outcomes (5)
Proportion of healthcare workers who report satisfaction with providing cervical cancer services
Acceptability and feasibility of service provision as measured through routine assessments
Measured: 12 months after model implementation
Proportion of healthcare workers who report satisfaction with providing family planning services
Acceptability and feasibility of service provision as measured through routine assessments
Measured: 12 months after model implementation
Proportion of clients who report satisfaction with cervical cancer services received at study facilities
Acceptability and feasibility of cervical cancer screening and preventive therapy as measured through client exit surveys
Measured: 12 months after model implementation
Proportion of clients who report satisfaction with family planning services received at study facilities
Acceptability of family planning services as measured through client exit surveys
Measured: 12 months after model implementation
Cost of the intervention
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
Measured: 12 months after model implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start4 Mar 2020
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 8,174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Jennifer Tang, MD, MSCR, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286243
- Sponsor's protocol ID
- 19-0638
- Other IDs
- UNCPM 21904
- Status last verified
- May 2022
- First submitted
- 24 Feb 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
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.
PubMed 33879259
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNCPM 21904 - Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT04286243
- Acronym / sponsor ID
- 19-0638
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,174 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Model 1 - Clinic Based Screening | Active comparator | Other: Clinic-based HPV screening strategyModel 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 - Community Based Screening | Experimental | Other: Community-based HPV screening strategyModel 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 |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Health care staff member must be currently working at one of the 16 health facilities selected for the study.
- Woman must have participated in cervical cancer screening via HPV self-sampling through one of the 16 health facilities during the study period.
- Woman who received or declined VFP and/or CCS services in the catchment area of the targeted facilities.
- Woman must be between the ages of 15-50 years.
Key exclusion criteria (2 listed)
- Woman who has had her cervix removed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based HPV screening strategyOffering HPV self-collection for cervical cancer screening in the community | Other | Model 2 - Community Based Screening |
| Clinic-based HPV screening strategyOffering HPV self-collection for cervical cancer screening in the clinic | Other | Model 1 - Clinic Based Screening |
Primary outcome
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
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
5 secondary outcomes
Proportion of healthcare workers who report satisfaction with providing cervical cancer services
Time frame: 12 months after model implementation
Proportion of healthcare workers who report satisfaction with providing family planning services
Time frame: 12 months after model implementation
Proportion of clients who report satisfaction with cervical cancer services received at study facilities
Time frame: 12 months after model implementation
Proportion of clients who report satisfaction with family planning services received at study facilities
Time frame: 12 months after model implementation
Cost of the intervention
Time frame: 12 months after model implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 33879259Tang 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.
- Individual participant dataSharing planned: 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).
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Tang, MD, MSCR principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based HPV screening strategy and Clinic-based HPV screening strategy in people with Cervical Cancer, run by University of North Carolina, Chapel Hill at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women who receive cervical cancer screening in Model 2 (time frame: 12 months after model implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.