N/A N=240 Randomized Screening

The Prevent Anal Cancer Self-Swab Study

Anal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03489707 ↗

Enrolled (actual)

240

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Compliance With Annual Anal HPV DNA Screening — 107; 89; 13; 31 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Home-based human papillomavirus (HPV) DNA screening (Behavioral); Clinic-based human papillomavirus (HPV) DNA screening (Behavioral)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: Medical College of Wisconsin
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Compliance With Annual Anal HPV DNA Screening	78; 63; 42; 57	—
PRIMARY Compliance With Annual Anal HPV DNA Screening	78; 63; 42; 57	—
SECONDARY Compliance With Annual Screening Based on HIV Status	27; 6; 11; 21; 51; 57	—
SECONDARY Compliance With Annual Screening Based on Race/Ethnicity	49; 50; 27; 32; 19; 6	—
SECONDARY Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity	41; 54; 35; 28; 11; 8	—
SECONDARY Number of Participants Attending High-resolution Anoscopy Based on HIV Status	20; 12; 18; 15; 42; 59	—
SECONDARY Attendance at High-resolution Anoscopy	62; 71; 58; 49	—

Summary

The purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (MSM) and transgender persons. This study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this affects a person's decision to have high-resolution anoscopy.

Eligibility Criteria

Inclusion Criteria

Be > 25 years of age
Sex at birth is male or gender identity is a transgender person
Acknowledge sex with men in the last 5 years, or identify as gay or bisexual
Understand and be willing to give informed consent
Be willing to be randomized and able to comply with the protocol
Spanish and/or English speakers/readers, and
HIV+ or HIV-

Exclusion Criteria

Not acknowledge sex with men in the past five years and not identify as gay or bisexual
Use of anticoagulants other than Aspirin or NSAIDS
Prior diagnosis of anal cancer
Plans to move within 12 months
Not Milwaukee metro residents
Not willing to attend one of the designated study clinics at baseline, or
Inability to give informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03489707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.