Study Evaluating an anti-HIV douche using Simulated Anal Intercourse

Someone at John Hopkins University in Baltimore, MD, is having way too much fun. 😜

https://clinicaltrials.gov/ct2/show/NCT04195776

Researchers at Hopkins are about to start recruiting sixteen adult men for a research study to test an antiviral douche used prior to receptive anal intercourse (RAI) to prevent HIV infection. Subjects in the experimental arm of the study are in for a wild ride! Each man, once they are enrolled in the study, is going to come into the clinic to collect baseline samples. This will probably include a complete physical exam including a DRE. The samples they take will at least be blood, saliva, semen, and rectal fluids. And then the fun really begins.

Each man will attend three sessions at the clinic. First, they masturbate into a petri dish to collect a semen sample which is then radiolabeled with an isotope for detection later. There will probably be another exam and some baseline samples taken. Then the man climbs up on the table in his gown, takes the proper position, and receives a 125 mL enema of tenofovir antiviral medication. I'm not sure, but after some retention time, the man may be allowed to visit the toilet and release the solution if it isn't necessary for all of it to be absorbed.

Back on the table, the man will assume an appropriate position in which to receive simulated receptive anal intercourse (sRAI) from an artificial phallus embedded with a catheter simulating the urethra. Coitus with this highly scientific device goes for five minutes with sixty cycles of thrusting every minute. At the end of the three-hundredth cycle, the phallus will be inserted to a maximum depth in the man's rectum and his own radiolabeled semen will be injected into him. After the simulated ejaculation has completed, the phallus will continue to thrust in and out of the man's rectum for an additional ten seconds before being removed.

The man is required to remain in the hospital for the next day or so while scans and samples are taken. The radiolabeled autologous semen will show how far ejaculated fluid penetrated into the man's colon. Once the session is complete, the man gets a two-week "wash-out" period before returning for the next round. In each round, the order and contents of the douche are changed. Sometimes it starts with the tenofovir followed by sRAI followed by a tap-water douche. Other sessions start with the tap-water and ends with the antiviral medication.

The purpose of the study is to determine the safety, acceptance, pharmacokinetics, and pharmacodynamics of using this PrEP douche prior to receiving anal sex. If this study and future studies go well, gay bottoms may be able to pick up a prescription for the stuff by 2024, and there will be one more weapon in the fight against HIV/AIDS. Horray!

But I can't help thinking about what it will be like for those sixteen brave, pioneering men, giving up their tender bottoms to probing, biopsy, douching, and rough robot sex - and so that the rest of us can hope for the day when rawdogging it with hung top is just a little less risky. I salute you, men. Godspeed!

(Oh, and where can I sign up. Oh, please!?! I'll be a good patient, I promise! I just want to offer my butt for science. Is that too much to ask?)

Actually if this works it could be a positive development. I don't know specifics, but I do read things going back and forth on rates in the US. An additional weapon in the fight could be a good thing.

I do have to wonder about the equipment though. Undoubtedly it is designed primarily for functionality and safety, but do you suppose it will be or was intentionally designed to be comfortable or intentionally designed to be uncomfortable?

Also wondering how long they wait between providing the sample and the simulated intercourse. From the point of view of the study there would be no difference, but the closer the test is to the sample the less pleasant it would be for the subjects I imagine.

Wow!!!

Please may I volunteer to be first on the list for any related UK based studies?

Seriously, what an exciting way to be helping with a more than worthwhile study!?! ... Lucky buggers! 😈

I continue to read up on this line of research. Tenofovir is, of course, one half of Truvada, the pre-exposure prophylactic (PReP) daily pill to reduce the risk of an HIV infection. I've been taking it for about a year. Tenofovir, in the oral form, apparently works its way into every part of the body at a prophylactic level rather well - except for one place, the epithelial mucosa of the rectum where only about 20% as much is present as in the rest of the body. Better than nothing, but we would all like more protection.

That's where the concepts of gels, enemas, suppositories, and douches containing Tenofovir (and other antiviral concoctions) come into the picture. Apparently, these studies have been going on for more than a decade. You can find studies like this one as well as studies of just what kind of rectal application gay men would be most willing to take - enemas, douches, gels, lubes, suppositories, etc. Once the subject gets his "squirt", the researchers tear into his ass (literally) to find out just how much of the agent made it into the walls of his rectum. Compare that to where the analogous semen got deposited to determine if the product would make a difference.

The part about Truvada not protecting as well against infection specifically for unprotected receptive anal intercourse (uRAI) makes me feel a little bit cheated given all the hype and the expense of Gilead's Truvada.

I like reading about sex related research. Very interesting. Always wondered how you volunteer for such a thing and if the scientists can perform the tests without getting excited.

I once read the results of a study in Spain, don’t remember but I think about conception rates, but anyway the study required the scientists to measure the distance between the vagina and the center of the anus. The subjects were 25 young Spanish women. I would love to observe that!

Very nice and well stayed post Jacob!

Thank you for sharing your info and good luck with signing up! 😊

it COULD be a very interesting experience!

Bruce

Even if gets great results would you risk it? If a partner has the virus you have to use a condom surely.

I'm sorry but this makes me cringe!

I'm sorry but this makes me cringe!

The key to all of this stuff is you have to sort of "get your geek on" so to speak, and look at it from how they have identified a problem, figured out a possible solution, and figured out a way to safely and ethically test it.

That said, I am the type who was fascinated watching things such as my own vasectomy and comparing strategies the doctor used as well as the pictures from the anatomy books to the real thing. YMMV.

It's likely the only way I would ever be in a study like that would be if someone I knew was running it and they specifically asked me. Though there would be an upside - I'd have a good reason to tell my wife to peg me - "it's for science..."