Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa
NCT ID: NCT05414097
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
348 participants
OBSERVATIONAL
2022-07-16
2023-10-20
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Semi-structured focus group discussions - Women
Semi-structured focus group discussions to explore women's experiences with cervical cancer screening and treatment.
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.
semi-structured focus groups discussions - Men
Semi-structured focus group discussions to explore partner dynamics related to women's ability to access cancer screening.
Phase 1: 12 Key Stakeholders - IDIs
Stakeholder interviewers with women's groups, women's health providers, laboratory personnel, NGOs, and public health organizations.
In-depth key stakeholders interviews
In-depth interviews to contextualise findings from women and men focus group discussions.
Phase 2: 300 women - DCE
Discrete Choice Experiment enrolling women 18 years of age and older.
Discrete Choice Experiment - Women
Discrete Choice Experiment to determine preferences to different cancer screening models.
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.
Development and User Pre-testing Workshops
Development and User Pre-testing Workshops to explore acceptability and feasibility of proposed interventions designed using findings from Phases 1 \&2.
Interventions
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Semi-structured focus group discussions - Women
Semi-structured focus group discussions to explore women's experiences with cervical cancer screening and treatment.
semi-structured focus groups discussions - Men
Semi-structured focus group discussions to explore partner dynamics related to women's ability to access cancer screening.
In-depth key stakeholders interviews
In-depth interviews to contextualise findings from women and men focus group discussions.
Discrete Choice Experiment - Women
Discrete Choice Experiment to determine preferences to different cancer screening models.
Development and User Pre-testing Workshops
Development and User Pre-testing Workshops to explore acceptability and feasibility of proposed interventions designed using findings from Phases 1 \&2.
Eligibility Criteria
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Inclusion Criteria
1. HIV-positive
2. Women 18 years and older
3. Participants should be willing and able to provide written informed consent
Focus Groups with HIV-negative Women
1. HIV-negative
2. Women 18 years and older
3. Participants should be willing and able to provide written informed consent
Focus Groups with Men
1. Male partners who are 18 years and older
2. Participants should be willing and able to provide written informed consent
In-depth Interviews with Key Stakeholders
1. Healthcare providers working within the public health system and other key stakeholders
2. Individuals 18 years and older
3. Participants should be willing and able to provide written informed consent
Exclusion Criteria
1. Women younger than 18 years
2. Unwilling or unable to provide written informed consent
Focus Groups with HIV-negative Women
1. Women younger than 18 years
2. Unwilling or unable to provide written informed consent
Focus Groups with Men
1. Male partners younger than 18 years
2. Participants unwilling or unable to provide written informed consent
In-depth Interviews with Key Stakeholders
1. Providers who do not work in the public health system
2. Individuals younger than 18 years
3. Participants unwilling or unable to provide written informed consent
18 Years
ALL
Yes
Sponsors
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Fogarty International Center of the National Institute of Health
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Carla Chibwesha, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics and Gynecology University of North Carolina at Chapel Hill
Locations
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Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, South Africa
Countries
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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IGHID12101
Identifier Type: -
Identifier Source: org_study_id
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