PrEP Research Study
Researchers at the Cornell Clinical Trials Unit are conducting the REVUP study (HPTN 106) to test a potential new method for preventing HIV in men who have sex with men (MSM) and transgender women (TGW), comparing an investigational medicated rectal douche with an oral pill study regimen.
Fast Facts
Have Sexual Intercourse With Men
Assigned Male
at Birth
Compensation Provided
Conducted in NYC
Study Background
The purpose of this study is to compare the safety and effectiveness of two potential methods for preventing HIV in men who have sex with men (MSM) and transgender women (TGW). Researchers will test an investigational medicated rectal douche containing the anti-HIV drug tenofovir against an oral 2-1-1 pill study regimen, which is already known for its effectiveness in HIV prevention.
HIV remains a significant public health challenge, particularly among MSM and TGW populations, who are at higher risk of HIV transmission. Existing prevention methods, such as oral pre-exposure prophylaxis (PrEP), have shown effectiveness, but there is a need for additional options that may be more acceptable or convenient for individuals. Some people prefer alternative forms of prevention, and the use of a medicated rectal douche is one such possibility.
This study aims to evaluate the acceptability and safety of using a tenofovir-based rectal douche as an HIV prevention method, alongside the established 2-1-1 oral pill regimen. By exploring both options, researchers hope to offer more choices for people at risk of HIV, ultimately contributing to better prevention strategies and improved health outcomes in high-risk communities.
Study Background
The purpose of this study is to compare the safety and effectiveness of two potential methods for preventing HIV in men who have sex with men (MSM) and transgender women (TGW). Researchers will test an investigational medicated rectal douche containing the anti-HIV drug tenofovir against an oral 2-1-1 pill study regimen, which is already known for its effectiveness in HIV prevention.
HIV remains a significant public health challenge, particularly among MSM and TGW populations, who are at higher risk of HIV transmission. Existing prevention methods, such as oral pre-exposure prophylaxis (PrEP), have shown effectiveness, but there is a need for additional options that may be more acceptable or convenient for individuals. Some people prefer alternative forms of prevention, and the use of a medicated rectal douche is one such possibility.
This study aims to evaluate the acceptability and safety of using a tenofovir-based rectal douche as an HIV prevention method, alongside the established 2-1-1 oral pill regimen. By exploring both options, researchers hope to offer more choices for people at risk of HIV, ultimately contributing to better prevention strategies and improved health outcomes in high-risk communities.
Additional Information
This study is being done to test two different methods of preventing HIV in men who have sex with men (MSM) and transgender women (TGW), comparing a medicated rectal douche with an oral pill regimen to see which option is safer and more acceptable.
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Assigned male at birth
- Have sexual intercourse with men
- Not currently using PrEP
- HIV negative
- A history of receptive anal intercourse (bottoming) at least once in the prior 3 months
- Have used a rectal douche or enema in the past
- No active hepatitis B (HBV) infection
- No known sexual partners living with HIV (unless they have sustained viral suppression)
If you participate, you will be asked to attend several study visits over about 19 weeks, where you will receive either the medicated rectal douche or the oral pill regimen, and complete various study-related tasks, including reporting your experiences.
You will be compensated for your time, with payments of $75 per study visit, an additional $75 when all enema tips are returned, and $120 for completing and submitting study diaries, totaling up to approximately $800. Plus, you’ll receive snacks, free condoms, and lube as additional perks during your participation.
There is no cost for you to participate in our research study.
