Clinical trial · Interventional
The Prevent Anal Cancer Self-Swab Study
Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer
NCT03489707CI-TRIAL-00082437completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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 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.
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 |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinic-based human papillomavirus (HPV) DNA screening | Behavioral | — | UNRESOLVED |
| Home-based human papillomavirus (HPV) DNA screening | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Home-based human papillomavirus (HPV) DNA screening
- description
- Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
- interventionNames
- Behavioral: Home-based human papillomavirus (HPV) DNA screening
- type
- ACTIVE_COMPARATOR
- label
- Clinic-based human papillomavirus (HPV) DNA screening
- description
- Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
- interventionNames
- Behavioral: Clinic-based human papillomavirus (HPV) DNA screening
Primary outcomes (2)
- measure
- Compliance With Annual Anal HPV DNA Screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDNitkowski J, Giuliano AR, Ridolfi T, Chiao E, Fernandez ME, Schick V, Swartz MD, Smith JS, Nyitray AG. Acceptability of Anal Human Papillomavirus Home Self-Sampling and Clinician Sampling Among Sexual and Gender Minority Individuals in Milwaukee, Wisconsin: The Prevent Anal Cancer Self-Swab Study. LGBT Health. 2024 Jan;11(1):47-56. doi: 10.1089/lgbt.2023.0012. Epub 2023 Oct 24. PMID 37870947
- DERIVEDNyitray AG, Schick V, Swartz MD, Giuliano AR, Fernandez ME, Deshmukh AA, Ridolfi TJ, Ajala C, Brzezinski B, Sandoval M, Nedjai B, Smith JS, Chiao EY. Rationale and design of the Prevent Anal Cancer Self-Swab Study: a protocol for a randomised clinical trial of home-based self-collection of cells for anal cancer screening. BMJ Open. 2021 Jun 29;11(6):e051118. doi: 10.1136/bmjopen-2021-051118. PMID 34187833