Cervical CarcinomaNCT04927650
Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening
An observational study of Cervical Carcinoma and Human Papillomavirus-Related Carcinoma, run by University of California, San Francisco at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Carcinoma, Human Papillomavirus-Related Carcinoma
- What is being tested?
- HPV testing and Questionnaire Administration
- How many people
- 2,556 participants
- Where
- 1 siteUganda
- Study dates
- 8 Jan 2015to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women in the three Ugandan districts (Kiboga, Kyankwanzi and Hoima) who access screening during the community health campaigns
Who may be able to join
- 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
Who cannot join
- Clinical signs and symptoms of cancer of the cervix
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Makerere University College of Health Sciences School of Medicine
Kampala
About this study
Official title: 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.
Read the 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.
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.
- Being tested
- HPV testing, Questionnaire Administration
- Keywords
- Cervical Cancer Screening, Human Papillomavirus, HPV
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV testingDiagnostic test
Undergo collection of cervical samples for HPV testing
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: HPV testing; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete screening
The absolute number of participants successfully completing screening.
Measured: 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.
Measured: 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.
Measured: 6 months
Proportion of participants with positive, high-risk human papillomavirus (HPV)
Prevalence of participants with positive high-risk human papillomavirus (HPV)
Measured: 1 day
Proportion of participants with cervical intraepithelial neoplasia (CIN2)+
Proportion of participants with cervical intraepithelial neoplasia (CIN2)+
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start8 Jan 2015
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Martin, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927650
- Sponsor's protocol ID
- 18405
- Other IDs
- NCI-2021-02021, U54CA190153, U54CA254571
- Status last verified
- Apr 2026
- First submitted
- 9 Jun 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening in the Community
- ClinicalTrials.gov ID
- NCT04927650
- Acronym / sponsor ID
- 18405
- Keywords
- Cervical Cancer Screening, Human Papillomavirus, HPV
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,556 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jan 2015 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Diagnostic Test: HPV testing, Other: Questionnaire AdministrationPatients 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 may qualify
- Ages
- 25 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women in the three Ugandan districts (Kiboga, Kyankwanzi and Hoima) who access screening during the community health campaigns
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Clinical signs and symptoms of cancer of the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV testingUndergo collection of cervical samples for HPV testing | Diagnostic test | Screening |
| Questionnaire AdministrationComplete questionnaires | Other | Screening |
Primary outcome
Number of participants who complete screening
Time frame: 1 day
The absolute number of participants successfully completing screening.
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.
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.
Proportion of participants with positive, high-risk human papillomavirus (HPV)
Time frame: 1 day
Prevalence of participants with positive high-risk human papillomavirus (HPV)
Proportion of participants with cervical intraepithelial neoplasia (CIN2)+
Time frame: 1 day
Proportion of participants with cervical intraepithelial neoplasia (CIN2)+
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Martin, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Carcinoma and Human Papillomavirus-Related Carcinoma, run by University of California, San Francisco at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete screening (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.