High-risk HPV Testing With Pap Smear Triage for Cervical Cancer Screening in Women Aged 50 and Older in Ethiopia
NCT07929246, Not yet recruiting, University Medical Center Groningen
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | High-risk HPV Testing With Pap Smear Triage for Cervical Cancer Screening in Women Aged 50 and Older in Ethiopia | ClinicalTrials.gov |
| NCT number | NCT07929246 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 3,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Medical Center Groningen | ClinicalTrials.gov |
| Conditions | Uterine Cervical Neoplasms, Papillomavirus Infections, Uterine Cervical Dysplasia | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Prevalence of high-risk HPV infection and genotype distribution in women aged 50 and older | At enrollment (single time point, from the self-collected sample) | Proportion of women with a positive hrHPV result on the self-collected sample (ScreenFire RS assay), among all women with a valid result, with a 95% confidence interval. Genotype distribution among hrHPV-positive women across four risk channels (HPV16; HPV18/45; HPV31/33/35/52/58; HPV39/51/56/59/68), as counts and percentages. | ClinicalTrials.gov |
| Primary | Diagnostic accuracy of cytology against biopsy-confirmed CIN2+ in hrHPV-positive women | From enrollment until the biopsy result is available (completion of the diagnostic pathway) | Sensitivity, specificity, positive predictive value and negative predictive value (each with 95% confidence interval) of conventional cytology (Bethesda System) against the biopsy reference standard (CIN2+ present or absent), read by a pathologist blinded to the hrHPV and cytology results. Calculated among hrHPV-positive women who complete cytology, colposcopy and biopsy. | ClinicalTrials.gov |
| Secondary | CIN2+ detection and referral efficiency of two referral strategies in hrHPV-positive women | From enrollment until the biopsy result is available (completion of the diagnostic pathway) | Strategy A refers all hrHPV-positive women to colposcopy. Strategy B refers only hrHPV-positive women with abnormal cytology. Both are applied retrospectively to the same women. Compared: number and proportion of biopsy-confirmed CIN2+ cases detected, CIN2+ cases missed under Strategy B, and referrals and colposcopies needed per CIN2+ case detected. | ClinicalTrials.gov |
| Secondary | Resource use of two referral strategies: colposcopy referrals per 1,000 women screened and unnecessary referrals | From enrollment until the biopsy result is available (completion of the diagnostic pathway) | Number and proportion of women referred to colposcopy without biopsy-confirmed CIN2+ (unnecessary referrals), calculated separately for Strategy A (all hrHPV-positive women) and Strategy B (only hrHPV-positive women with abnormal cytology), together with the number of colposcopy referrals per 1,000 women screened under each strategy. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)