Cervical CancerCASAHONCT06166420
Home-based Cervical Cancer Screening Project
A study testing Experimental and Active comparator in people with Cervical Cancer, run by Prof. Patrick Petignat at 1 site in Cameroon.
Trial summary
Cervical cancer is a public health problem in Cameroon.In 2020, the country had a crude incidence of 20.2 per 100 000 women for an incidence to mortality ratio of 0.65. As for now, the country does not have a national screening program to combat the disease. Read more about this study
- Who is it for?
- Ages 30 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Experimental and Active comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,079 participants
- Where
- 1 siteCameroon
- Study dates
- 27 Mar 2023to 31 Aug 2024
- 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 30 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 30-49 years
- Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).
- Non-inclusion criteria:
- Pregnancy at the time of screening
- History of cervical cancer screening by HPV test of less than 5 years (for HIV-negative women) or less than 3 years (for HIV positive women).
- Intra-vaginal treatment
Who cannot join
- Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
- Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)
- Women who are not able to comply with the study protocol.
- Previous hysterectomy
- Known cervical cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Offering Home-based Versus Hospital-based HPV Counseling and Testing for Cervical Cancer Screening in Rural West Region of Cameroon: a Randomised Cluster Trial
Cervical cancer is a public health problem in Cameroon.In 2020, the country had a crude incidence of 20.2 per 100 000 women for an incidence to mortality ratio of 0.65. As for now, the country does not have a national screening program to combat the disease. Only 6% of cameroonian women have once been screened for cervical cancer. In order to increase screening uptake so as to reach 70% recommended by the World Health Organization (WHO), a home-based cervical cancer screening approach is proposed. The objective of our study is to compare two recruitment strategies for cervical cancer screening in rural Cameroon.
Read the detailed description
In 2018, a 5 years cervical cancer screening project called: "Promoting Comprehensive Cervical Cancer Prevention and Better Women's Health in Low- and Medium Resource Settings in the Health District of Dschang" was launched in the West Region of Cameroon. The study aimed at screening 2000 women per year following screen-triage-treatment as recommended by WHO in a 3T approach: Test with HPV self-sampling test, Triage by visual assessement of the cervix with acetic acid and lugol (VIA/VILI), Treatment with thermal ablation. Despite sensitization using communication information channels, uptake of the screening was below the target. In order to increase uptake of the screening, this study proposes a home-based strategy using Community Health Workers (CHW). Community Health Workers (CHW) are lay members of the community who carry out health promotion activities after training. In a randomised controlled cluster trial, two recruitment strategies for cervical cancer screening will be compared: in one arm a team made up of a CHW and a nurse will do door-to-door sensitization and propose home-based HPV self-sampling test to eligible women and in the other arm CHW will do door-to-door sensitization and issue invitation cards to eligible women for hospital-based HPV self-sampling test. This study is nested in ongoing cervical cancer screening project.
Primary objective: To compare completeness of full screening between two different recruitment strategies in rural area: counselling and home-based HPV self-sampling test versus counselling and hospital-based HPV self-sampling test.
Secondary objectives:
- To determine the proportion of women who will carry out an HPV self-sampling test in both strategies within 3 months of sensitization.
- To determine the proportion of HPV positive women who will undergo VIA/VILI in both arms within 3 months.
- To assess the acceptability of home self-sampling HPV test and perception of single versus 2 visits approaches.
- To determine predictors of non-adherence to care-seeking for HPV positive women.
- To determine the number of pre-cancers and/or cancers diagnosed in both arms and their treatment.
- To calculate the economic cost of both strategies.
Mixed method design, quantitative and qualitative informations will be collected.
- Conditions
- Cervical Cancer
- Being tested
- Experimental, Active comparator
- Keywords
- cervical cancer, human papillomavirus, screening, home-based
- 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.
ExperimentalOther
Counseling on cervical cancer screening followed by home-based HPV self-sampling test proposal.
Active comparatorOther
Counseling on cervical cancer screening followed invitation to screen at Dschang District Hospital.
| Study group | Role | What they receive |
|---|---|---|
| home-based | Experimental | A team made up of a Community Health Worker (CHW) and a nurse will do door-to-door sensitization and propose to eligible women to undergo HPV self-sampling test at home. Samples collected will be taken by the nurse to the hospital for HPV testing . Participants will receive a phone call: disclosure of the HPV test's result will be by phone call for HPV-negative participants; HPV-positive participants will be invited to the hospital for disclosure of their results. At the hospital, HP-positive participants will undergo visual assessment of their cervix and treatment if needed. Receives: Other: Experimental |
| hospital-based | Active comparator | Community Health Worker (CHW) will do door-to-door sensitization and invite eligible women to attend cervical cancer screening at District Hospital Dschang. At the hospital they will do HPV self-sampling test. HPV-negative women will be advised to repeat the test after 5 years while HPV positive women will undergo visual assessment of the cervix with acetic acid and lugol (VIA/VILI) and treatment if needed. Receives: Other: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants who will complete full screening (HPV test +/- VIA/VILI +/- treatment when necessary) in both arms within 3 months of sensitization
The number and percentage of participants who will do an HPV self test+/- VIA/VILI+/- treatment par study arm
Measured: 3 months
Secondary outcomes (6)
Number and percentage of women who will do an HPV test within 3 months of sensitization per study arm
The number and percentage of participants who will do an HPV test in each arm of the study.
Measured: 3 months from sensitization
Number and percentage of participants once tested HPVpositive who will link to the pelvic exam for visual assessment and treatment (if needed) within 3 months.
The number and percentage of participants once tested HPV positive who link to the hospital for visual assessment of the cervix and treatment if needed.
Measured: 3 months from HPV self sample collection
Identify barriers and enablers to the home-HPV self-sampling test.
Factors that prevent and motivate women to participate to a home-based HPV self-test.
Measured: 4 months
Identify barriers and enablers of linkage to VIA for HPV positive women
Factors that prevent and motivate participants who did a home-based HPV self-test to link to the hospital for visual assesment of the cervix using acetic acid and lugol (VIA/VILI).
Measured: 4 months
Number of pre-cancers and/or cancers diagnosed in each study arm.
The number of pre-cancers and cancers diagnosed per study arm.
Measured: 2 years
Cost of each screening strategy.
The cost of each strategy and make a cost-effectiveness analysis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start27 Mar 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms randomised controlled cluster trial
- Masking
- None (open label)
- Enrolment
- 2,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Patrick Petignat
- Sponsor type
- University, hospital or other
- Collaborators
- Dschang District Hospital
- Responsible party
- Sponsor-investigator, Prof. Patrick Petignat, University Hospital, Geneva
- Investigators
- Patrick Petignat, Pr, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166420
- Sponsor's protocol ID
- N°2022/10/1494/CE/CNERSH/SP
- Acronym
- CASAHO
- Status last verified
- Jan 2025
- First submitted
- 4 Dec 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data may be shared upon reasonable request at the end of the study period.
Publications
Moukam AMD, Salah N, Tankeu Happi GW, Metchehe LDD, Makajio SL, Wisniak A, Sormani J, Kenfack B, Vassilakos P, Socpa A, Petignat P, Schmidt NC. Acceptability of home-based HPV self-sampling for cervical cancer screening among users and providers in the West region of Cameroon: a cross-sectional study. BMC Health Serv Res. 2025 Oct 3;25(1):1303. doi: 10.1186/s12913-025-13467-1.
PubMed 41044580
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offering Home-based Versus Hospital-based HPV Counseling and Testing for Cervical Cancer Screening in Rural West Region of Cameroon: a Randomised Cluster Trial
- ClinicalTrials.gov ID
- NCT06166420
- Acronym / sponsor ID
- CASAHO / N°2022/10/1494/CE/CNERSH/SP
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, human papillomavirus, screening, home-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,079 participants (actual)
- Lead sponsor
- Prof. Patrick PetignatUniversity, hospital or other
- Collaborators
- Dschang District Hospital
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 12 Dec 2023 (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.
Cervical cancer is a public health problem in Cameroon.In 2020, the country had a crude incidence of 20.2 per 100 000 women for an incidence to mortality ratio of 0.65. As for now, the country does not have a national screening program to combat the disease. Only 6% of cameroonian women have once been screened for cervical cancer. In order to increase screening uptake so as to reach 70% recommended by the World Health Organization (WHO), a home-based cervical cancer screening approach is proposed. The objective of our study is to compare two recruitment strategies for cervical cancer screening in rural Cameroon.
Detailed description
In 2018, a 5 years cervical cancer screening project called: "Promoting Comprehensive Cervical Cancer Prevention and Better Women's Health in Low- and Medium Resource Settings in the Health District of Dschang" was launched in the West Region of Cameroon. The study aimed at screening 2000 women per year following screen-triage-treatment as recommended by WHO in a 3T approach: Test with HPV self-sampling test, Triage by visual assessement of the cervix with acetic acid and lugol (VIA/VILI), Treatment with thermal ablation. Despite sensitization using communication information channels, uptake of the screening was below the target. In order to increase uptake of the screening, this study proposes a home-based strategy using Community Health Workers (CHW). Community Health Workers (CHW) are lay members of the community who carry out health promotion activities after training. In a randomised controlled cluster trial, two recruitment strategies for cervical cancer screening will be compared: in one arm a team made up of a CHW and a nurse will do door-to-door sensitization and propose home-based HPV self-sampling test to eligible women and in the other arm CHW will do door-to-door sensitization and issue invitation cards to eligible women for hospital-based HPV self-sampling test. This study is nested in ongoing cervical cancer screening project.
Primary objective: To compare completeness of full screening between two different recruitment strategies in rural area: counselling and home-based HPV self-sampling test versus counselling and hospital-based HPV self-sampling test.
Secondary objectives:
- To determine the proportion of women who will carry out an HPV self-sampling test in both strategies within 3 months of sensitization.
- To determine the proportion of HPV positive women who will undergo VIA/VILI in both arms within 3 months.
- To assess the acceptability of home self-sampling HPV test and perception of single versus 2 visits approaches.
- To determine predictors of non-adherence to care-seeking for HPV positive women.
- To determine the number of pre-cancers and/or cancers diagnosed in both arms and their treatment.
- To calculate the economic cost of both strategies.
Mixed method design, quantitative and qualitative informations will be collected.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms randomised controlled cluster trial
| Arm | Type | Receives |
|---|---|---|
| home-based | Experimental | Other: ExperimentalA team made up of a Community Health Worker (CHW) and a nurse will do door-to-door sensitization and propose to eligible women to undergo HPV self-sampling test at home. Samples collected will be taken by the nurse to the hospital for HPV testing . Participants will receive a phone call: disclosure of the HPV test's result will be by phone call for HPV-negative participants; HPV-positive participants will be invited to the hospital for disclosure of their results. At the hospital, HP-positive participants will undergo visual assessment of their cervix and treatment if needed. |
| hospital-based | Active comparator | Other: Active comparatorCommunity Health Worker (CHW) will do door-to-door sensitization and invite eligible women to attend cervical cancer screening at District Hospital Dschang. At the hospital they will do HPV self-sampling test. HPV-negative women will be advised to repeat the test after 5 years while HPV positive women will undergo visual assessment of the cervix with acetic acid and lugol (VIA/VILI) and treatment if needed. |
Who may qualify
- Ages
- 30 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 30-49 years
- Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF).
- Pregnancy at the time of screening
- History of cervical cancer screening by HPV test of less than 5 years (for HIV-negative women) or less than 3 years (for HIV positive women).
- Intra-vaginal treatment
Key exclusion criteria (5 listed)
- Symptoms of cervical cancer (e.g. metrorrhagia, known pelvic mass)
- Severe pre-existing medical conditions (e.g. advanced cancer, terminal renal failure)
- Women who are not able to comply with the study protocol.
- Previous hysterectomy
- Known cervical cancer
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 |
|---|---|---|
| ExperimentalCounseling on cervical cancer screening followed by home-based HPV self-sampling test proposal. | Other | home-based |
| Active comparatorCounseling on cervical cancer screening followed invitation to screen at Dschang District Hospital. | Other | hospital-based |
Primary outcome
Number and percentage of participants who will complete full screening (HPV test +/- VIA/VILI +/- treatment when necessary) in both arms within 3 months of sensitization
Time frame: 3 months
The number and percentage of participants who will do an HPV self test+/- VIA/VILI+/- treatment par study arm
6 secondary outcomes
Number and percentage of women who will do an HPV test within 3 months of sensitization per study arm
Time frame: 3 months from sensitization
Number and percentage of participants once tested HPVpositive who will link to the pelvic exam for visual assessment and treatment (if needed) within 3 months.
Time frame: 3 months from HPV self sample collection
Identify barriers and enablers to the home-HPV self-sampling test.
Time frame: 4 months
Identify barriers and enablers of linkage to VIA for HPV positive women
Time frame: 4 months
Number of pre-cancers and/or cancers diagnosed in each study arm.
Time frame: 2 years
Cost of each screening strategy.
Time frame: 2 years
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 15 Jan 2025.
- Derived from this study: PubMed 41044580Moukam AMD, Salah N, Tankeu Happi GW, Metchehe LDD, Makajio SL, Wisniak A, Sormani J, Kenfack B, Vassilakos P, Socpa A, Petignat P, Schmidt NC. Acceptability of home-based HPV self-sampling for cervical cancer screening among users and providers in the West region of Cameroon: a cross-sectional study. BMC Health Serv Res. 2025 Oct 3;25(1):1303. doi: 10.1186/s12913-025-13467-1.
- Individual participant dataSharing planned: Undecided. Anonymised data may be shared upon reasonable request at the end of the study period.
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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.
Patrick Petignat, Pr principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Active comparator in people with Cervical Cancer, run by Prof. Patrick Petignat at 1 site in Cameroon.
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 6 inclusion and 5 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 15 Jan 2025. 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 Cameroon. 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?
Number and percentage of participants who will complete full screening (HPV test +/- VIA/VILI +/- treatment when necessary) in both arms within 3 months of sensitization (time frame: 3 months). 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 NCT06166420, 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 15 Jan 2025.