Clinical trial · Interventional
Telehealth & HPV Self-Collection
Cervical Cancer Screening: Evaluation of Telehealth to Enhance HPV Self-Collection
- 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)
This study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. This will be done by evaluating sufficient Human papillomavirus (HPV) sample collection and determining preference for self-collection verses provider collection, comparing role of telehealth in pre- and post- menopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits.
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 |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Receive routine instructions | Other | — | UNRESOLVED |
| Telehealth-based instructional visit and receive routine instructions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Receive routine instructions
- description
- Participants will receive routine instructions included in the myLAB Box Clinical Laboratory Improvement Amendments (CLIA) certified collection kit
- interventionNames
- Other: Receive routine instructions
- type
- ACTIVE_COMPARATOR
- label
- Telehealth Visit
- description
- Participants will have a telehealth-based instructional visit and receive routine instructions included in the myLAB Box commercially available, CLIA certified collection kit
- interventionNames
- Other: Telehealth-based instructional visit and receive routine instructions
Primary outcomes (1)
- measure
- Proportion of participants preferring self-collection to provider collection
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines. * Pregnant women are eligible for participation in this study as the collection process poses no threat to the woman or her fetus. Exclusion Criteria: * Individuals without a cervix * Have had prior pelvic radiation therapy or brachytherapy * Active or former diagnosis of ovarian, uterine, or cervical cancer unless determined eligible by PI upon further review of history and treatment * Individuals less than age 25 or no longer eligible/recommended to undergo cervical cancer screening * Adults who are unable to consent or are decisionally impaired * Individuals who are not English speaking
References
Publications (0)
Data not yet available