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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervical Carcinoma; Human Papillomavirus-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Diagnostic test: HPV testing

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 2556

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere University College of Health Sciences School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.	Other: Questionnaire Administration; Complete questionnaires; Diagnostic test: HPV testing; Undergo collection of cervical samples for HPV testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who complete screening	The absolute number of participants successfully completing screening.	1 day
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
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
Proportion of participants with positive, high-risk human papillomavirus (HPV)	Prevalence of participants with positive high-risk human papillomavirus (HPV)	1 day
Proportion of participants with cervical intraepithelial neoplasia (CIN2)+	Proportion of participants with cervical intraepithelial neoplasia (CIN2)+	1 day

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeffrey Martin, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2015
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cervical Cancer Screening; HPV; Human Papillomavirus
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 18405; NCI-2021-02021 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U54CA190153 (U.S. NIH Grant/Contract); U54CA254571 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No