Clinical trial · Interventional
HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals
Advancing Cervical Cancer Screening Through Self-Sampling (ACCESS): A Pilot Study of HPV Self-sampling for Cervical Cancer Prevention in Washington State
- 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 objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Self-collection kits will be offered to persons who refuse a Pap smear or are overdue (\>=6 months) for cervical cancer screening, with screening uptake recorded as a primary outcome. Kits will be offered in-clinic to individuals who refuse a Pap smear, and individuals overdue for screening will have the option to receive and return kits in the mail. The investigators will additionally administer a phone-based survey to evaluate knowledge about HPV and cervical cancer, barriers and facilitators to screening, and attitudes towards screening. Data from medical records will be abstracted to describe the clinical characteristics of the sample and measure receipt of follow-up procedures. Focus groups will be conducted with clinic administrators, staff, and HIV and women's health experts to evaluate clinic and provider barriers and facilitators to cervical cancer screening. The investigators hypothesize that HPV self-sampling will result in favorable patient-centered outcomes and could reduce disparities in access to screening.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flocked swab paired with Roche Cobas 4800 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV self-sampling
- description
- Participants will be offered self-collection kits for HPV-based cervical cancer screening.
- interventionNames
- Device: Flocked swab paired with Roche Cobas 4800
Primary outcomes (6)
- measure
- Proportion of eligible individuals who accept self-sampling kits
- timeFrame
- Baseline (during clinical and/or study recruitment encounter)
- description
- the proportion of eligible individuals due or overdue for screening who agree to collect a vaginal sample for HPV testing.
- measure
- Proportion of eligible individuals who submit self-sampled specimens
- timeFrame
- 3 weeks from enrollment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>=25 and \<65 (individuals without diagnosed HIV) or \>=30 years (individuals with diagnosed HIV) * Female sex at birth * Proficient in English or Spanish * Refused a Pap smear or are \>=6 months overdue for cervical cancer screening Exclusion Criteria: * Current pregnancy * Complete hysterectomy * History of cervical cancer * Unable to provide informed consent
References
Publications (0)
Data not yet available