Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa

Cervical Cancer Clinical Trial

— FIND  

Official title:

Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05414097
• Other study ID #: IGHID12101
• Secondary ID: R21TW011715-01
• Status: Completed
• Start date: July 16, 2022
• Est. completion date: October 20, 2023

Study information

• Verified date: April 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 interventions that will address barriers to cervical cancer screening and improve engagement in care among women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Focus Groups with HIV-positive Women

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:

Focus Groups with HIV-positive Women

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
South Africa	Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital	Westdene	Johannesburg

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Single visit
Secondary	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.	Single visit

External Links

•   University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials