Clinical trial NCT04927650: Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening
Official title: Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening in the Community
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Carcinoma
Human Papillomavirus-Related Carcinoma
Keywords: Cervical Cancer Screening
Human Papillomavirus
HPV
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-16
Enrollment: 3200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who complete screening
timeFrame: 1 day
measure: Proportion of women 25-49 years of age who complete screening
timeFrame: 1 day
measure: Proportion of participants who receive treatment after a positive screening result
timeFrame: 6 months
measure: Proportion of participants with positive, high-risk human papillomavirus (HPV)
timeFrame: 1 day
measure: Proportion of participants with cervical intraepithelial neoplasia (CIN2)+
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University College of Health Sciences School of Medicine
Study officials:
affiliation: University of California, San Francisco
name: Jeffrey Martin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: