Cervical CancerFINDNCT05414097
Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa
An observational study of Cervical Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in South Africa.
Trial summary
The primary aim of the study explore drivers of cervical cancer screening and barriers contributing to low screening coverage among women in South Africa. Secondary aims are determining preferences for cervical cancer prevention services using a discrete choice experiment and developing a multi-level package of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Semi-structured focus group discussions - Women, semi-structured focus groups discussions - Men and In-depth key stakeholders interviews
- How many people
- 348 participants
- Where
- 1 siteSouth Africa
- Study dates
- 16 Jul 2022to 20 Oct 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants for the study will be recruited from both urban and peri-urban settings in Johannesburg, South Africa. The population consists of women who have previously undergone screening/treatment for cervical cancer and those who have not; male partners of these women; and key stakeholders within public health systems.
Who may be able to join
- Focus Groups with HIV-positive Women
- HIV-positive
- Women 18 years and older
- Participants should be willing and able to provide written informed consent
- Focus Groups with HIV-negative Women
- HIV-negative
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- Women 18 years and older
- Participants should be willing and able to provide written informed consent
- Focus Groups with Men
- Male partners who are 18 years and older
- Participants should be willing and able to provide written informed consent
- In-depth Interviews with Key Stakeholders
- Healthcare providers working within the public health system and other key stakeholders
- Individuals 18 years and older
- Participants should be willing and able to provide written informed consent
Who cannot join
- Focus Groups with HIV-positive Women
- Women younger than 18 years
- Unwilling or unable to provide written informed consent
- Focus Groups with HIV-negative Women
- Women younger than 18 years
- Unwilling or unable to provide written informed consent
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- Focus Groups with Men
- Male partners younger than 18 years
- Participants unwilling or unable to provide written informed consent
- In-depth Interviews with Key Stakeholders
- Providers who do not work in the public health system
- Individuals younger than 18 years
- Participants unwilling or unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, 2092
About this study
The primary aim of the study explore drivers of cervical cancer screening and barriers contributing to low screening coverage among women in South Africa. Secondary aims are determining preferences for cervical cancer prevention services using a discrete choice experiment and developing a multi-level package of interventions that will address barriers to cervical cancer screening and improve engagement in care among women.
Read the detailed description
Cervical cancer is a leading cause of cancer death among South African women. Despite a comprehensive national cancer control policy, cervical screening coverage is low and attrition during on-ward referrals for diagnostic confirmation and treatment remains common.
This study uses a sequential mixed-methods design:
Phase 1) A qualitative exploratory phase using focus groups and in-depth interviews with women, men, other stakeholders will inform our design and interpretation of quantitative findings from a multi-cohort DCE.
Phase 2) Women will be recruited to participate in the DCE and determine their preferences for cancer screening services.
Phase 3) Design Thinking to co-create an intervention package for cervical cancer screening and enhanced linkage between screening, diagnosis, and treatment will be created.
- Conditions
- Cervical Cancer
- Being tested
- Semi-structured focus group discussions - Women, semi-structured focus groups discussions - Men, In-depth key stakeholders interviews, Discrete Choice Experiment - Women, Development and User Pre-testing Workshops
- Keywords
- sequential mixed-methods, HIV, screening
- 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.
Semi-structured focus group discussions - WomenOther
Semi-structured focus group discussions to explore women's experiences with cervical cancer screening and treatment.
semi-structured focus groups discussions - MenOther
Semi-structured focus group discussions to explore partner dynamics related to women's ability to access cancer screening.
In-depth key stakeholders interviewsOther
In-depth interviews to contextualise findings from women and men focus group discussions.
Discrete Choice Experiment - WomenOther
Discrete Choice Experiment to determine preferences to different cancer screening models.
Development and User Pre-testing WorkshopsOther
Development and User Pre-testing Workshops to explore acceptability and feasibility of proposed interventions designed using findings from Phases 1 \&2.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: 24 Women - FGDs | Focus groups enrolling HIV-positive, previously screened for cervical cancer; HIV-positive, not previously screened for cervical cancer; HIV-negative, previously screened for cervical cancer; HIV-negative, not previously screened for cervical cancer. Receives: Other: Semi-structured focus group discussions - Women | |
| Phase 1: 16 Men - FGDs | Focus groups enrolling male partners referred by women previously screened or treated for cervical cancer and by women not previously screened for cervical cancer. Receives: Other: semi-structured focus groups discussions - Men | |
| Phase 1: 12 Key Stakeholders - IDIs | Stakeholder interviewers with women's groups, women's health providers, laboratory personnel, NGOs, and public health organizations. Receives: Other: In-depth key stakeholders interviews | |
| Phase 2: 300 women - DCE | Discrete Choice Experiment enrolling women 18 years of age and older. Receives: Other: Discrete Choice Experiment - Women | |
| Phase 3: 36 Women, women's health providers, and policy makers | Stakeholder groups comprising individuals 18 years and older who participated in Phase 1 will be eligible. Receives: Other: Development and User Pre-testing Workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Barriers to cancer screening and engagement
Barriers and enablers will be explored through focus groups and in-depth interviews with women, men, and other stakeholders.
Measured: Single visit
Secondary outcomes (2)
Phase 2: Woman preferences for cancer screening services
Preferences for cancer screening will be determined through the relative importance of the attribute according on how it is scored in the Discrete Choice Experiment.
Measured: Single visit
Phase 3: Acceptability and feasibility of multi-level package of interventions addressing barriers to cancer screening.
Acceptability and feasibility will be measured through development and user pre-testing workshops.
Measured: Single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start16 Jul 2022
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Carla Chibwesha, MD, MSc, Principal investigator, Department of Obstetrics and Gynecology University of North Carolina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414097
- Sponsor's protocol ID
- IGHID12101
- Other IDs
- R21TW011715-01
- Acronym
- FIND
- Status last verified
- Apr 2024
- First submitted
- 7 Jun 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual data will however be shared widely. We will make research datasets available to South African investigators who request access and meaningfully involve in-country investigators in all our activities, including the production of research manuscripts and presentations at scientific meetings. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations. Data sharing mechanisms will ensure that the rights and privacy of individuals participating in NIH sponsored research will be protected at all times.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa
- ClinicalTrials.gov ID
- NCT05414097
- Acronym / sponsor ID
- FIND / IGHID12101
- Conditions
- Cervical Cancer
- Keywords
- sequential mixed-methods, HIV, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 16 Jul 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 10 Jun 2022 (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 primary aim of the study explore drivers of cervical cancer screening and barriers contributing to low screening coverage among women in South Africa. Secondary aims are determining preferences for cervical cancer prevention services using a discrete choice experiment and developing a multi-level package of interventions that will address barriers to cervical cancer screening and improve engagement in care among women.
Detailed description
Cervical cancer is a leading cause of cancer death among South African women. Despite a comprehensive national cancer control policy, cervical screening coverage is low and attrition during on-ward referrals for diagnostic confirmation and treatment remains common.
This study uses a sequential mixed-methods design:
Phase 1) A qualitative exploratory phase using focus groups and in-depth interviews with women, men, other stakeholders will inform our design and interpretation of quantitative findings from a multi-cohort DCE.
Phase 2) Women will be recruited to participate in the DCE and determine their preferences for cancer screening services.
Phase 3) Design Thinking to co-create an intervention package for cervical cancer screening and enhanced linkage between screening, diagnosis, and treatment will be created.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1: 24 Women - FGDs | – | Other: Semi-structured focus group discussions - WomenFocus groups enrolling HIV-positive, previously screened for cervical cancer; HIV-positive, not previously screened for cervical cancer; HIV-negative, previously screened for cervical cancer; HIV-negative, not previously screened for cervical cancer. |
| Phase 1: 16 Men - FGDs | – | Other: semi-structured focus groups discussions - MenFocus groups enrolling male partners referred by women previously screened or treated for cervical cancer and by women not previously screened for cervical cancer. |
| Phase 1: 12 Key Stakeholders - IDIs | – | Other: In-depth key stakeholders interviewsStakeholder interviewers with women's groups, women's health providers, laboratory personnel, NGOs, and public health organizations. |
| Phase 2: 300 women - DCE | – | Other: Discrete Choice Experiment - WomenDiscrete Choice Experiment enrolling women 18 years of age and older. |
| Phase 3: 36 Women, women's health providers, and policy makers | – | Other: Development and User Pre-testing WorkshopsStakeholder groups comprising individuals 18 years and older who participated in Phase 1 will be eligible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for the study will be recruited from both urban and peri-urban settings in Johannesburg, South Africa. The population consists of women who have previously undergone screening/treatment for cervical cancer and those who have not; male partners of these women; and key stakeholders within public health systems.
Key inclusion criteria (15 listed)
- Focus Groups with HIV-positive Women
- HIV-positive
- Women 18 years and older
- Participants should be willing and able to provide written informed consent
- Focus Groups with HIV-negative Women
Key exclusion criteria (13 listed)
- Focus Groups with HIV-positive Women
- Women younger than 18 years
- Unwilling or unable to provide written informed consent
- Focus Groups with HIV-negative Women
- Women younger than 18 years
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 |
|---|---|---|
| Semi-structured focus group discussions - WomenSemi-structured focus group discussions to explore women's experiences with cervical cancer screening and treatment. | Other | Phase 1: 24 Women - FGDs |
| semi-structured focus groups discussions - MenSemi-structured focus group discussions to explore partner dynamics related to women's ability to access cancer screening. | Other | Phase 1: 16 Men - FGDs |
| In-depth key stakeholders interviewsIn-depth interviews to contextualise findings from women and men focus group discussions. | Other | Phase 1: 12 Key Stakeholders - IDIs |
| Discrete Choice Experiment - WomenDiscrete Choice Experiment to determine preferences to different cancer screening models. | Other | Phase 2: 300 women - DCE |
| Development and User Pre-testing WorkshopsDevelopment and User Pre-testing Workshops to explore acceptability and feasibility of proposed interventions designed using findings from Phases 1 \&2. | Other | Phase 3: 36 Women, women's health providers, and policy makers |
Primary outcome
Phase 1: Barriers to cancer screening and engagement
Time frame: Single visit
Barriers and enablers will be explored through focus groups and in-depth interviews with women, men, and other stakeholders.
2 secondary outcomes
Phase 2: Woman preferences for cancer screening services
Time frame: Single visit
Phase 3: Acceptability and feasibility of multi-level package of interventions addressing barriers to cancer screening.
Time frame: Single visit
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 Apr 2024.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Deidentified individual data will however be shared widely. We will make research datasets available to South African investigators who request access and meaningfully involve in-country investigators in all our activities, including the production of research manuscripts and presentations at scientific meetings. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations. Data sharing mechanisms will ensure that the rights and privacy of individuals participating in NIH sponsored research will be protected at all times.
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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.
Carla Chibwesha, MD, MSc principal investigator
Department of Obstetrics and Gynecology University of North Carolina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in South Africa.
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 15 inclusion and 13 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 Apr 2024. 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 South Africa. 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?
Phase 1: Barriers to cancer screening and engagement (time frame: Single visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.