About this trial
This study looks at ways to improve anal cancer screening for people at higher risk. It will find out if self-sampling from the anal canal can help people attend their medical appointments for testing. Researchers will also see if letting people choose between self-sampling or having a healthcare provider do the sampling makes a difference in attendance.
The trial's ID number is NCT07192055. It is not a drug or device trial regulated by the FDA. About 572 people are expected to participate.
Who can join
This trial is open to men and women aged 35 and older if they are HIV-positive, or 45 and older if they are HIV-negative. Participants must be a sexual minority man or a transgender woman who has sex with men. They should live in the Chicago, Houston, or Milwaukee areas and be willing to attend a study clinic. They need to speak and understand English or Spanish and agree to complete a consent form. Some people may not be able to join, like those who have participated in a similar study or have certain health conditions.
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed in different groups by chance. Some will self-sample the anal canal at home and at a clinic. Others will have a clinician collect a sample from them at the clinic. There will also be groups using two types of swabs: a nylon-flocked swab and a Dacron swab. Instructions on how to self-sample will be provided to those in the self-sampling group.
Where
This trial is running at 3 locations in the United States. All of them are currently recruiting.
Medical College of Wisconsin
Milwaukee, Wisconsin
The University of Texas M.D. Anderson Cancer Center
Houston, Texas
University of Chicago
Chicago, Illinois