Clinical trial · Observational
A New Approach to Cervical Cancer Prevention in Kenya
NCT03942705CI-TRIAL-00077955completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if the human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing, performed on self-collected vaginal swabs, is acceptable, feasible, and sensitive and specific in detection of high-grade cervical lesions among Kenyan women, compared to the current standard of care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Kenyan Women
- description
- Women living in western Kenya will be asked to complete a self collected vaginal sample for HPV DNA screening and asked to undergo a second screening by VIA. As per Kenyan standard of care, vaccination against HPV will be offered to children/grandchildren (boys and girls) of women, and to the women themselves if age 26 or younger. The second vaccine dose (for children ages 9 through 14) and third doses (for children and adult women ages 15 through 26) will be administered at subsequent visits. There will be no requirement for HPV vaccination (of children or mothers up to 26 years of age) for participation in the study. Results of the screening will be returned to participants and they will be referred to receive standard care as applicable.
Primary outcomes (2)
- measure
- Percentage of women attending community meetings who will provide self-collected vaginal swabs for HPV DNA testing.
- timeFrame
- anytime after informed consent up to 2 years
- measure
- Percentage of women who attend clinic after providing self-collected vaginal swabs
- timeFrame
- any time after completion of self-collected vaginal swab (up to 2 years)
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Women who live in Kenya who are between the ages of 30 and 55, are willing to provide a self collected vaginal swab and willing to travel to the local clinic for a VIA Exclusion Criteria: 1\. current pregnancy, inability to consent due to mental or physical disability, or a medical illness that has rendered the patient unable to understand consent
References
Publications (0)
Data not yet available
No reference posted for this study.