PrEP Research Study
Researchers at The Fenway Institute are conducting the study Rev Up (HPTN 106), which aims to expand PrEP options.
Fast Facts
Have Sexual Intercourse with Men
Assigned Male at Birth
Compensation Provided
Conducted in
Boston, MA
Study Background
Through Rev Up (HPTN 106), researchers at The Fenway Institute aim to expand PrEP options to include a medicated rectal douche for those who have receptive anal intercourse.
Currently, PrEP options for preventing sexual HIV acquisition include oral tablets, a monthly vaginal ring, and bi-monthly injectables. While these options can be effective, they may not successfully prevent HIV acquisition if taken incorrectly.
We want to expand PrEP options to include a single dose,
tenofovir (TFV) rectal microbicide douche. The purpose of this research study is to evaluate the safety, acceptability, and preference of this investigational medicated rectal douche compared to the on-demand oral option.
Further research on HIV prevention by joining our compensated study.
Study Background
Through Rev Up (HPTN 106), researchers at The Fenway Institute aim to expand PrEP options to include a medicated rectal douche for those who have receptive anal intercourse.
Currently, PrEP options for preventing sexual HIV acquisition include oral tablets, a monthly vaginal ring, and bi-monthly injectables. While these options can be effective, they may not successfully prevent HIV acquisition if taken incorrectly.
We want to expand PrEP options to include a single dose,
tenofovir (TFV) rectal microbicide douche. The purpose of this research study is to evaluate the safety, acceptability, and preference of this investigational medicated rectal douche compared to the on-demand oral option.
Further research on HIV prevention by joining our compensated study.
Additional Information
The purpose of this research study is to evaluate the safety, acceptability, and preference of an investigational tenofovir (TFV) rectal microbicide douche compared to the on-demand oral option.
You may qualify for a 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 significant colorectal symptoms (e.g., IBD, symptomatic external hemorrhoids, painful anorectal conditions)
- No known sexual partners living with HIV (unless they have sustained viral suppression)
- Willing and able to use condoms for the study
- No significant health concerns including cardiac or pulmonary events, GI bleeding, recurrent urticaria, etc.
This research study will consist of 7 in-person clinic visits and 5 phone calls. Participants will also be asked to complete daily eDiaries about product use.
Each study visit will take approximately 2 hours. During study visits, participants can expect to complete:
- Vital sign collection
- Medical history review
- Training on how to use study product
- Review of adherence to study product
- Sample collection for safety lab testing
- Risk-reduction counseling
Phone calls will each last approximately 10-15 minutes, and will focus on adverse events and problem-solving.
As a participant, you can receive up to $1,225 for completing all study visits.
There is no cost for you to participate in our research study.
Parking and ride share reimbursement (within 20 miles of study site) is also available for participants.
