Who is sponsoring NCT03489707?

NCT03489707 is sponsored by Medical College of Wisconsin.

What drugs are being tested in NCT03489707?

Interventions in NCT03489707: Home-based human papillomavirus (HPV) DNA screening, Clinic-based human papillomavirus (HPV) DNA screening.

What condition does NCT03489707 study?

NCT03489707 studies Anal Cancer.

Is NCT03489707 still recruiting?

NCT03489707 is currently completed. Last updated 12 November 2024.

Are results published for NCT03489707?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-12 · How we verify

NCT03489707

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Prevent Anal Cancer Self-Swab Study

Completed NA Results posted Last updated 12 November 2024

What this trial tests

NA trial testing Home-based human papillomavirus (HPV) DNA screening in Anal Cancer in 253 participants. Completed in 31 August 2023.

Timeline

9 January 2020

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	253
Start date	9 January 2020
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	1 location across United States

Drugs / interventions tested

Home-based human papillomavirus (HPV) DNA screening
Clinic-based human papillomavirus (HPV) DNA screening

Conditions studied

Anal Cancer — all drugs for Anal Cancer →

Sponsor

Medical College of Wisconsin

Who can join

25 and older, any sex, with Anal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Compliance With Annual Anal HPV DNA Screening Primary · Baseline

Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	107
Clinic-based Human Papillomavirus (HPV) DNA Screening	89
Home-based Human Papillomavirus (HPV) DNA Screening	13
Clinic-based Human Papillomavirus (HPV) DNA Screening	31

Compliance With Annual Anal HPV DNA Screening Primary · 12 months

Compliance is assessed by the number of participants who provide specimens for annual anal HPV DNA screening

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	78
Clinic-based Human Papillomavirus (HPV) DNA Screening	63
Home-based Human Papillomavirus (HPV) DNA Screening	42
Clinic-based Human Papillomavirus (HPV) DNA Screening	57

Compliance With Annual Screening Based on HIV Status Secondary · 12 months 12 months

The number of participants complying with annual screening with positive or negative HIV status. Compliance is defined as screening at baseline and one year.

HIV-positive

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	27
Clinic-based Human Papillomavirus (HPV) DNA Screening	6
Home-based Human Papillomavirus (HPV) DNA Screening	11
Clinic-based Human Papillomavirus (HPV) DNA Screening	21

HIV-negative

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	51
Clinic-based Human Papillomavirus (HPV) DNA Screening	57
Home-based Human Papillomavirus (HPV) DNA Screening	31
Clinic-based Human Papillomavirus (HPV) DNA Screening	36

Compliance With Annual Screening Based on Race/Ethnicity Secondary · 12 months

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.

White/Non Hispanic

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	49
Clinic-based Human Papillomavirus (HPV) DNA Screening	50
Home-based Human Papillomavirus (HPV) DNA Screening	27
Clinic-based Human Papillomavirus (HPV) DNA Screening	32

Black/Non-Hispanic

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	19
Clinic-based Human Papillomavirus (HPV) DNA Screening	6
Home-based Human Papillomavirus (HPV) DNA Screening	7
Clinic-based Human Papillomavirus (HPV) DNA Screening	13

Hispanic

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	9
Clinic-based Human Papillomavirus (HPV) DNA Screening	6
Home-based Human Papillomavirus (HPV) DNA Screening	6
Clinic-based Human Papillomavirus (HPV) DNA Screening	10

Asian (Not Hispanic or Latino)

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	0
Home-based Human Papillomavirus (HPV) DNA Screening	1
Clinic-based Human Papillomavirus (HPV) DNA Screening	0

American Indian/Alaskan Native (Not Hispanic or Latino)

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	0
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	1

I don't know/Not Reported

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	1
Clinic-based Human Papillomavirus (HPV) DNA Screening	0
Home-based Human Papillomavirus (HPV) DNA Screening	1
Clinic-based Human Papillomavirus (HPV) DNA Screening	0

Other

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	1
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	1

Number of Participants Attending High-resolution Anoscopy Based on Race/Ethnicity Secondary · 12 months

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.

White/Non-Hispanic

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	41
Clinic-based Human Papillomavirus (HPV) DNA Screening	54
Home-based Human Papillomavirus (HPV) DNA Screening	35
Clinic-based Human Papillomavirus (HPV) DNA Screening	28

Black/Non-Hispanic

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	11
Clinic-based Human Papillomavirus (HPV) DNA Screening	8
Home-based Human Papillomavirus (HPV) DNA Screening	15
Clinic-based Human Papillomavirus (HPV) DNA Screening	11

Hispanic

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	9
Clinic-based Human Papillomavirus (HPV) DNA Screening	7
Home-based Human Papillomavirus (HPV) DNA Screening	6
Clinic-based Human Papillomavirus (HPV) DNA Screening	9

Asian (Not Hispanic or Latino)

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	0
Home-based Human Papillomavirus (HPV) DNA Screening	1
Clinic-based Human Papillomavirus (HPV) DNA Screening	0

American Indian/Alaskan Native (Not Hispanic or Latino)

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	0
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	1

Other (Not Hispanic or Latino)

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	2
Home-based Human Papillomavirus (HPV) DNA Screening	1
Clinic-based Human Papillomavirus (HPV) DNA Screening	0

I don't know/Not reported

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	1
Clinic-based Human Papillomavirus (HPV) DNA Screening	0
Home-based Human Papillomavirus (HPV) DNA Screening	0
Clinic-based Human Papillomavirus (HPV) DNA Screening	0

Number of Participants Attending High-resolution Anoscopy Based on HIV Status Secondary · 12 months

The number of participants attending high-resolution anoscopy based on positive or negative HIV status.

HIV-positive

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	20
Clinic-based Human Papillomavirus (HPV) DNA Screening	12
Home-based Human Papillomavirus (HPV) DNA Screening	18
Clinic-based Human Papillomavirus (HPV) DNA Screening	15

HIV-negative

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	42
Clinic-based Human Papillomavirus (HPV) DNA Screening	59
Home-based Human Papillomavirus (HPV) DNA Screening	40
Clinic-based Human Papillomavirus (HPV) DNA Screening	34

Attendance at High-resolution Anoscopy Secondary · 12 months

Number of participants who attend high-resolution anoscopy (HRA)

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	62
Clinic-based Human Papillomavirus (HPV) DNA Screening	71
Home-based Human Papillomavirus (HPV) DNA Screening	58
Clinic-based Human Papillomavirus (HPV) DNA Screening	49

Human Papillomavirus (HPV) DNA Persistence and Its Association With High-grade Squamous Intraepithelial Lesions (HSIL). Secondary · 12 months

The number of participants that have DNA persistence at 12 months with and without high-grade squamous intraepithelial lesions (HSIL).

Attended HRA

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	62
Clinic-based Human Papillomavirus (HPV) DNA Screening	71

Assessed for persistence

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	60
Clinic-based Human Papillomavirus (HPV) DNA Screening	55

Persistent

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	36
Clinic-based Human Papillomavirus (HPV) DNA Screening	17

persistent ≥HSIL

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	14
Clinic-based Human Papillomavirus (HPV) DNA Screening	9

persistent <HSIL

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	22
Clinic-based Human Papillomavirus (HPV) DNA Screening	8

Not persistent

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	24
Clinic-based Human Papillomavirus (HPV) DNA Screening	38

not persistent ≥HSIL

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	3
Clinic-based Human Papillomavirus (HPV) DNA Screening	4

not persistent < HSIL

Group	Value	95% CI
Home-based Human Papillomavirus (HPV) DNA Screening	21
Clinic-based Human Papillomavirus (HPV) DNA Screening	34

Host/Viral Methylation and Its Association With High-grade Squamous Intraepithelial Lesions. Secondary · 12 months

Mean of host/viral methylation score among participants stratified by high-grade squamous intraepithelial lesions. The Score 5 (S5) methylation score is an arithmetic continuous risk score with a minimum value of 0 and no maximum value. Higher methylation scores indicate higher risk for disease. While a theoretical maximum for a methylation score does not exist, one published maximum value for anal cancer is approximately 100. In this publication (Lorincz et al., Methylation of HPV and a tumor suppressor gene reveals anal cancer and precursor lesions, DOI: 10.18632/oncotarget.17984), a cut-off

≥HSIL

Group	Value	95% CI
Total Participants	6.98	± 5.89
Home-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score	6.99	± 6.70
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score	6.96	± 4.99

<HSIL

Group	Value	95% CI
Total Participants	3.31	± 2.92
Home-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score	3.58	± 2.97
Clinic-based Human Papillomavirus (HPV) DNA Screening Who Have Both Histology & Methylation Score	3.10	± 2.90

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Nyitray AG, Schick V, Swartz MD, Giuliano AR, et al · · 2021 · cited 12× · PMID 34187833 · DOI 10.1136/bmjopen-2021-051118
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.
Nitkowski J, Giuliano AR, Ridolfi T, Chiao E, et al · · 2024 · cited 6× · PMID 37870947 · DOI 10.1089/lgbt.2023.0012
Engagement and Factors Associated With Annual Anal Human Papillomavirus Screening Among Sexual and Gender Minority Individuals.
Nitkowski J, Ridolfi TJ, Lundeen SJ, Giuliano AR, et al · · 2025 · cited 1× · PMID 39316041 · DOI 10.1097/olq.0000000000002084
Anal Cancer Screening Prevalence in U.S. Cities and Factors Associated With Screening.
Nyitray AG, Walsh JL, Deshmukh AA, Chiao EY, et al · · 2026 · PMID 41966460 · DOI 10.1016/j.amepre.2026.108373

Verify or expand the search:

Other recruiting trials for Anal Cancer

Currently open trials in the same condition.

NCT07192055 — Self-sampling to Optimize Anal Lesion Outcomes · NA · recruiting
NCT07296237 — Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer · recruiting
NCT07124000 — DESTINY-PANTUMOUR04 · recruiting
NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers · Phase 1, PHASE2 · recruiting
NCT06670495 — HPV Genotype Attribution and Disease Burden of Anal Cancer in China · recruiting

Other Medical College of Wisconsin trials

Trials by the same sponsor.

NCT07260552 — Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease · not yet recruiting
NCT06795360 — Weight Changes After Incretin-mimetics · NA · not yet recruiting
NCT07228208 — Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes · NA · not yet recruiting
NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
NCT07434544 — Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03489707 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 12 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03489707.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing