Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa
FIND
2 other identifiers
observational
348
1 country
1
Brief 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 interventions that will address barriers to cervical cancer screening and improve engagement in care among women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 10, 2022
CompletedStudy Start
First participant enrolled
July 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2023
CompletedApril 15, 2024
April 1, 2024
1.3 years
June 7, 2022
April 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Single visit
Secondary Outcomes (2)
Phase 2: Woman preferences for cancer screening services
Single visit
Phase 3: Acceptability and feasibility of multi-level package of interventions addressing barriers to cancer screening.
Single visit
Study Arms (5)
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.
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.
Phase 1: 12 Key Stakeholders - IDIs
Stakeholder interviewers with women's groups, women's health providers, laboratory personnel, NGOs, and public health organizations.
Phase 2: 300 women - DCE
Discrete Choice Experiment enrolling women 18 years of age and older.
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.
Interventions
Semi-structured focus group discussions to explore women's experiences with cervical cancer screening and treatment.
Semi-structured focus group discussions to explore partner dynamics related to women's ability to access cancer screening.
In-depth interviews to contextualise findings from women and men focus group discussions.
Discrete Choice Experiment to determine preferences to different cancer screening models.
Development and User Pre-testing Workshops to explore acceptability and feasibility of proposed interventions designed using findings from Phases 1 \&2.
Eligibility Criteria
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.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
Westdene, Johannesburg, 2092, South Africa
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Chibwesha, MD, MSc
Department of Obstetrics and Gynecology University of North Carolina at Chapel Hill
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 10, 2022
Study Start
July 16, 2022
Primary Completion
October 20, 2023
Study Completion
October 20, 2023
Last Updated
April 15, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
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.