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

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Cervical Carcinoma

Human Papillomavirus-Related Carcinoma

Treatments

Other: Questionnaire Administration

Diagnostic Test: HPV testing

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04927650

18405

U54CA190153 (U.S. NIH Grant/Contract)

NCI-2021-02021 (Registry Identifier)

U54CA254571 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,200 estimated patients

Sex

Female

Ages

25 to 49 years old

Volunteers

Accepts Healthy Volunteers

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