Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening

Cervical Carcinoma Clinical Trial

Official title:

Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening in the Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04927650
• Other study ID #: 18405
• Secondary ID: NCI-2021-02021U5
• Status: Recruiting
• Start date: January 8, 2015
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Jeffrey Martin, MD, MPH
• Phone: (415) 514-8010
• Email: Jeffrey.Martin[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study examines prevention and early detection of cervical cancer through self-administration screening of patients in Western Uganda. The cervix is the opening of the uterus or womb, which is the organ that supports babies before they are born. There are simple tests that let doctors know whether or not patients have cells that may become cancer. Some of the tests determine whether patients have an increased risk for cervical disease, but they do not actually confirm that they have it: these are called "screening" tests. This study may help researchers determine how to best deliver cervical cancer prevention services using the HPV test.

Description:

PRIMARY OBJECTIVES:

I. To establish the acceptance and correlates of self-collected human papillomavirus (HPV)-ribonucleic acid (RNA) testing among women in the rural Ugandan community as well as the incidence and determinants of successful completion of the cervical cancer screening cascade from self-collected HPV testing to receipt of results.

II. To ascertain the frequency and determinants of successful acquisition of treatment among women who have HPV detected on self-collected swabs in rural Uganda.

III. To derive population-based estimates of the prevalence of high-risk HPV and cervical intraepithelial neoplasia (CIN) detected through community-based screening employing self-collected HPV RNA testing in rural Uganda.

OUTLINE:

Patients receive a specimen kit for collection of HPV samples. Patients complete questionnaire before and after collection HPV samples. Patients may also participate in an interview about general ideas in improving the screening and treatment process. Patients with positive results, undergo treatment for cervical cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 49 Years

Eligibility

Inclusion Criteria:

• Women in the three Ugandan districts (Kiboga, Kyankwanzi and Hoima) who access screening during the community health campaigns

• Age 25-49 years

• Resident in the study district

• Provision of informed consent

Exclusion Criteria:

• Clinical signs and symptoms of cancer of the cervix

Related Conditions & MeSH terms

• Carcinoma
• Cervical Carcinoma
• Human Papillomavirus-Related Carcinoma
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• HPV testing
Undergo collection of cervical samples for HPV testing

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
Uganda	Makerere University College of Health Sciences School of Medicine	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete screening	The absolute number of participants successfully completing screening.	1 day
Primary	Proportion of women 25-49 years of age who complete screening	Overall proportions of women 25-49 years old successfully completing cervical cancer screening.	1 day
Primary	Proportion of participants who receive treatment after a positive screening result	Proportion of participants who receive treatment after screening positive for high-risk human papillomavirus (HPV) will be calculated with a 95% confidence interval.	6 months
Primary	Proportion of participants with positive, high-risk human papillomavirus (HPV)	Prevalence of participants with positive high-risk human papillomavirus (HPV)	1 day
Primary	Proportion of participants with cervical intraepithelial neoplasia (CIN2)+	Proportion of participants with cervical intraepithelial neoplasia (CIN2)+	1 day