Health TrialsbyHealthPanel

Developing and Implementing HPV SCREENED

ConditionsCervical Cancer ScreeningHuman Papilloma Virus
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-65
SponsorRutgers, The State University of New Jersey

About this trial

This study will assess the feasibility of implementing HPV self-sampling as a primary cervical cancer screening strategy for under-screened women in the emergency department (ED). Eligible participants will receive education and an HPV self-sampling kit to complete in the ED. Individuals with HPV-positive results will be guided to follow-up care at a local clinic.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

biological women,

no prior hysterectomy or cervical cancer,

not pregnant,

last Pap >3 years, last co-test >5 years, or last HPV alone test >5 years,

Disqualifiers

currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy);

previous hysterectomy;

previous diagnosis of cervical cancer;

current menses

Trial design

Design model

Single group

Treatments tested in this trial

  • HPV Self-collection in the ED

    Behavioral

    Participants will be asked to collect a vaginal sample for HPV screening.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: HPV SCREENEDOther 1 intervention

Trial outcomes

Primary outcomes

1

Completion of ED-Based HPV Self-Sampling

Evaluate the proportion of eligible participants who complete HPV self-sampling during the emergency department visit.

Time frame
Day 1

Secondary outcomes

1

HPV Self Sampling Acceptability

Acceptability of Intervention Measure (AIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more acceptable.

Time frame
After results notification, an average of 1 week
2

HPV Self Sampling Feasibility

Feasibility of Intervention Measure (FIM) scale (Weiner et al., 2017). Scale values range from 1 to 5, where higher is more feasible.

Time frame
After results notification, an average of 1 week
3

HPV Knowledge

Cervical Cancer Knowledge Scale (CCKS)- 7 items where a higher score is more knowledge

Time frame
Day 1 and after results notification- an average of 1 week
4

Screening Completion

Proportion of HPV+ women who complete follow-up screening

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: