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

April 12, 2024 updated by: UNC Lineberger Comprehensive Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

348

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Johannesburg
      • Westdene, Johannesburg, South Africa, 2092
        • Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
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.
Phase 1: 12 Key Stakeholders - IDIs
Stakeholder interviewers with women's groups, women's health providers, laboratory personnel, NGOs, and public health organizations.
Other: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Barriers to cancer screening and engagement
Time Frame: Single visit
Barriers and enablers will be explored through focus groups and in-depth interviews with women, men, and other stakeholders.
Single visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 2: Woman preferences for cancer screening services
Time Frame: Single visit
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
Phase 3: Acceptability and feasibility of multi-level package of interventions addressing barriers to cancer screening.
Time Frame: Single visit
Acceptability and feasibility will be measured through development and user pre-testing workshops.
Single visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

Fogarty International Center of the National Institute of Health

Investigators

  • Principal Investigator: Carla Chibwesha, MD, MSc, Department of Obstetrics and Gynecology University of North Carolina at Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2022

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGHID12101
  • R21TW011715-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Cancer

Clinical Trials on In-depth key stakeholders interviews

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe