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

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT04927650

Collaborator

National Cancer Institute (NCI) (NIH)

3,200

Enrollment

Location

96.8

Anticipated Duration (Months)

33.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Carcinoma Human Papillomavirus-Related Carcinoma	Diagnostic Test: HPV testing Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVES:

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

3200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 8, 2015

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Screening 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.	Diagnostic Test: HPV testing Undergo collection of cervical samples for HPV testing Other: Questionnaire Administration Complete questionnaires

Arm

Intervention/Treatment

Screening

Diagnostic Test: HPV testing

Undergo collection of cervical samples for HPV testing

Other: Questionnaire Administration

Complete questionnaires

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Makerere University College of Health Sciences School of Medicine	Kampala		Uganda

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jeffrey Martin, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04927650

Other Study ID Numbers:

18405
NCI-2021-02021
U54CA190153
U54CA254571

First Posted:

Jun 16, 2021

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of California, San Francisco

Cervical Cancer Screening

Human Papillomavirus

HPV

Additional relevant MeSH terms:

Carcinoma

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Apr 27, 2022