Anal CancerNCT03489707
The Prevent Anal Cancer Self-Swab Study
A study testing Home-based human papillomavirus (HPV) DNA screening and Clinic-based human papillomavirus (HPV) DNA screening in people with Anal Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal Cancer
- What is being tested?
- Home-based human papillomavirus (HPV) DNA screening and Clinic-based human papillomavirus (HPV) DNA screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53202
About this study
Official title: Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer
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.
Read the detailed description
This is a prospective, randomized, two-arm clinical study to evaluate compliance with annual home-based vs clinic-based DNA screening of anal canal exfoliated cells among Milwaukee HIV+ and HIV- men who have sex with men (MSM) and transgender persons aged ≥25 years. At study entry, persons randomized to arm 1 will receive a home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the exfoliated cell specimen at 0 and 12 months. Then, persons will receive high-resolution anoscopy (HRA)-directed biopsy to assess precancerous lesions by study arm. We hypothesize that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm vs clinic-based arm. The proposed research could indicate that annual HPV DNA screening and subsequent HRA are acceptable to MSM and transgender persons; thus, we will determine how high-risk persons are identified for HRA in light of limited HRA resources. The duration of each participant's activities is expected to be 12 months. The study is expected have participant activity from 2019 to 2023.
- Conditions
- Anal Cancer
- Being tested
- Home-based human papillomavirus (HPV) DNA screening, Clinic-based human papillomavirus (HPV) DNA screening
- Keywords
- anal cancer, human papillomavirus
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based human papillomavirus (HPV) DNA screeningBehavioural
Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
Clinic-based human papillomavirus (HPV) DNA screeningBehavioural
Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Home-based human papillomavirus (HPV) DNA screening | Experimental | Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. Receives: Behavioral: Home-based human papillomavirus (HPV) DNA screening |
| Clinic-based human papillomavirus (HPV) DNA screening | Active comparator | Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. Receives: Behavioral: Clinic-based human papillomavirus (HPV) DNA screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance With Annual Anal HPV DNA Screening
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Measured: Baseline
Compliance With Annual Anal HPV DNA Screening
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Measured: 12 months
Secondary outcomes (5)
Compliance With Annual Screening Based on HIV Status
The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year.
Measured: 12 months 12 months
Compliance With Annual Screening Based on Race/Ethnicity
The number of participants complying with annual screening based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White.
Compliance is defined as screening at baseline and one year.
Measured: 12 months
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
The number of participants attending high-resolution anoscopy based on race/ethnicity. Racial and ethnic categories are defined by the NIH as follows: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, and White.
Measured: 12 months
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
The number of participants attending high-resolution anoscopy based on positive or negative HIV status.
Measured: 12 months
Attendance at High-resolution Anoscopy
Number of participants who attend high-resolution anoscopy (HRA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start9 Jan 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Alan Nyitray, PhD, Medical College of Wisconsin
- Investigators
- Alan G Nyitray, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489707
- Sponsor's protocol ID
- HSC-MS-17-0635
- Other IDs
- R01CA215403
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2018
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
Publications
Nitkowski 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.
PubMed 37870947Nyitray 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.
PubMed 34187833
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer
- ClinicalTrials.gov ID
- NCT03489707
- Acronym / sponsor ID
- HSC-MS-17-0635
- Conditions
- Anal Cancer
- Keywords
- anal cancer, human papillomavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, two-arm clinical study to evaluate compliance with annual home-based vs clinic-based DNA screening of anal canal exfoliated cells among Milwaukee HIV+ and HIV- men who have sex with men (MSM) and transgender persons aged ≥25 years. At study entry, persons randomized to arm 1 will receive a home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the exfoliated cell specimen at 0 and 12 months. Then, persons will receive high-resolution anoscopy (HRA)-directed biopsy to assess precancerous lesions by study arm. We hypothesize that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm vs clinic-based arm. The proposed research could indicate that annual HPV DNA screening and subsequent HRA are acceptable to MSM and transgender persons; thus, we will determine how high-risk persons are identified for HRA in light of limited HRA resources. The duration of each participant's activities is expected to be 12 months. The study is expected have participant activity from 2019 to 2023.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based human papillomavirus (HPV) DNA screening | Experimental | Behavioral: Home-based human papillomavirus (HPV) DNA screeningPersons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. |
| Clinic-based human papillomavirus (HPV) DNA screening | Active comparator | Behavioral: Clinic-based human papillomavirus (HPV) DNA screeningPersons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based human papillomavirus (HPV) DNA screeningPersons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months. | Behavioural | Home-based human papillomavirus (HPV) DNA screening |
| Clinic-based human papillomavirus (HPV) DNA screeningPersons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months. | Behavioural | Clinic-based human papillomavirus (HPV) DNA screening |
Primary outcome
Compliance With Annual Anal HPV DNA Screening
Time frame: Baseline
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
Compliance With Annual Anal HPV DNA Screening
Time frame: 12 months
Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening
5 secondary outcomes
Compliance With Annual Screening Based on HIV Status
Time frame: 12 months 12 months
Compliance With Annual Screening Based on Race/Ethnicity
Time frame: 12 months
Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity
Time frame: 12 months
Number of Participants Attending High-resolution Anoscopy Based on HIV Status
Time frame: 12 months
Attendance at High-resolution Anoscopy
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37870947Nitkowski 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.
- Derived from this study: PubMed 34187833Nyitray 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.
- Individual participant dataSharing planned: Yes. Fully de-identified datasets will be shared with properly trained investigators after assessment of institutional policies, Medical College of Wisconsin Human Protections Committee rules, as well as local, state, and Federal laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan G Nyitray, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based human papillomavirus (HPV) DNA screening and Clinic-based human papillomavirus (HPV) DNA screening in people with Anal Cancer, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance With Annual Anal HPV DNA Screening (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489707, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.