Clinical trial NCT05414097: Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa
Official title: Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: sequential mixed-methods
HIV
screening
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2022-06-10
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Phase 1: Barriers to cancer screening and engagement
timeFrame: Single visit
Secondary outcomes:
measure: Phase 2: Woman preferences for cancer screening services
timeFrame: Single visit
measure: Phase 3: Acceptability and feasibility of multi-level package of interventions addressing barriers to cancer screening.
timeFrame: Single visit
Other outcomes:
Locations:
city: Westdene
country: South Africa
facility: Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital
state: Johannesburg
Study officials:
affiliation: Department of Obstetrics and Gynecology University of North Carolina at Chapel Hill
name: Carla Chibwesha, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: