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

NCT ID: NCT05414097

Last Updated: 2024-04-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-16

Study Completion Date

2023-10-20

Brief Summary

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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

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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

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Cervical Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

semi-structured focus groups discussions - Men

Semi-structured focus group discussions to explore partner dynamics related to women's ability to access cancer screening.

Intervention Type OTHER

In-depth key stakeholders interviews

In-depth interviews to contextualise findings from women and men focus group discussions.

Intervention Type OTHER

Discrete Choice Experiment - Women

Discrete Choice Experiment to determine preferences to different cancer screening models.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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South Africa

Related Links

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http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

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R21TW011715-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IGHID12101

Identifier Type: -

Identifier Source: org_study_id

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