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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05414097
Recruitment Status : Recruiting
First Posted : June 10, 2022
Last Update Posted : August 11, 2022
Sponsor:
Collaborator:
Fogarty International Center of the National Institute of Health
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment
Cervical Cancer Other: Semi-structured focus group discussions Women Other: semi-structured focus groups discussion- Men Other: In-depth key stakeholders interviews Other: Discrete Choice Women Experiment Other: Development and User Pre-testing Workshops

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.

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Study Type : Observational
Estimated Enrollment : 388 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa
Actual Study Start Date : July 16, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
Phase 1 : 24 Women
HIV-positive, previously screened forcervical 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
Male partners in 4 focus groups, referred by women previously screened or treated for cervical cancer and referred by women not previously screened for cervical cancer
Other: semi-structured focus groups discussion- Men
Semi-structured focus group discussions to explore partner dynamics related to women's ability to access cancer screening

Phase 1: 12 Key stakeholders
Women's groups, Women's health providers, laboratory personnel, NGOs and public health organization
Other: In-depth key stakeholders interviews
In-depth interviews to contextualise findings from women and men focus group discussions.

Phase 2:300 women
Women 18 years of age and older will be eligible for participation
Other: Discrete Choice Women Experiment
Discrete Choice Experiment to determine preferences to different cancer screening models.

Phase 3: 36 Women, women's health providers, and policy makers.
Adults 18 years and older will be eligible for participation. Up to 12 women previously screened for the study, up to 12 women's health providers and up to 12 policy makers
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.




Primary Outcome Measures :
  1. Phase 1: Barriers to cancer screening and engagement [ Time Frame: 6 months ]
    Barriers and enablers will be explored through focus groups and in-depth interviews with women, men and other stakeholders.


Secondary Outcome Measures :
  1. Phase 2: Woman preferences for cancer screening services [ Time Frame: 1 year ]
    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.

  2. Phase 3: Acceptability and feasibility of multi-level package of interventions addressing barriers to cancer screening. [ Time Frame: 6 months ]
    Acceptability and feasibility will be measured through development and user pre-testing workshops.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. 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.
Criteria

Inclusion Criteria

Focus Groups with HIV-positive Women

  1. Participant should be willing and able to provide written informed consent.
  2. HIV-positive
  3. women 18 years and older

Focus Groups with HIV-negative Women

  1. Participant should be willing and able to provide written informed consent.
  2. HIV- negative
  3. women 18 years and older

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. Women's health providers working within public health system and other key health stakeholders
  2. women 18 years and older
  3. Participant should be willing and able to provide

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 who are 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. Unwilling or unable to provide written informed consent
  3. Younger than 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05414097


Contacts
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Contact: Cheryl Hendrickson (919) 843-2541 cheryl_hendrickson@med.unc.edu

Locations
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South Africa
Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital Recruiting
Westdene, Johannesburg, South Africa, 2092
Contact: Tafadzwa Pasipamire       tpasipamire@witshealth.co.za   
Principal Investigator: Carla Chibwesha, MD, MSc         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Fogarty International Center of the National Institute of Health
Investigators
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Principal Investigator: Carla Chibwesha, MD, MSc Department of Obstetrics and Gynecology University of North Carolina at Chapel Hill
Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05414097    
Other Study ID Numbers: IGHID12101
R21TW011715-01 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
sequential mixed-methods
HIV
screening
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases