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Active, Not Recruiting

NCT Number: NCT04927650

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus-Related Carcinoma Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Makerere University College of Health Sciences School of Medicine

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV testing

Diagnostic Test

Undergo collection of cervical samples for HPV testing

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Number of participants who complete screening

    Time frame: 1 day

    The absolute number of participants successfully completing screening.

  2. Proportion of women 25-49 years of age who complete screening

    Time frame: 1 day

    Overall proportions of women 25-49 years old successfully completing cervical cancer screening.

  3. Proportion of participants who receive treatment after a positive screening result

    Time frame: 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.

  4. Proportion of participants with positive, high-risk human papillomavirus (HPV)

    Time frame: 1 day

    Prevalence of participants with positive high-risk human papillomavirus (HPV)

  5. Proportion of participants with cervical intraepithelial neoplasia (CIN2)+

    Time frame: 1 day

    Proportion of participants with cervical intraepithelial neoplasia (CIN2)+

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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