NCT04927650

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,556

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2015Jan 2027

Study Start

First participant enrolled

January 8, 2015

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

12.1 years

First QC Date

June 9, 2021

Last Update Submit

April 28, 2026

Conditions

Cervical CarcinomaHuman Papillomavirus-Related Carcinoma

Keywords

Cervical Cancer ScreeningHuman PapillomavirusHPV

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

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.

Diagnostic Test: HPV testingOther: Questionnaire Administration

Interventions

HPV testingDIAGNOSTIC_TEST

Undergo collection of cervical samples for HPV testing

Screening
Questionnaire AdministrationOTHER

Complete questionnaires

Screening

Eligibility Criteria

Age25 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Clinical signs and symptoms of cancer of the cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University College of Health Sciences School of Medicine

Kampala, Uganda

Location

Biospecimen

Retention: SAMPLES WITH DNA

HPV samples

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jeffrey Martin, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

January 8, 2015

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)