N/A
Completed N=240
The Prevent Anal Cancer Self-Swab Study
Source: ClinicalTrials.gov NCT03489707 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Compliance With Annual Anal HPV DNA Screening — 107; 89; 13; 31 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 | — |
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
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. Informational only — not medical advice.