HIV Prevention Research Study

Researchers at University of North Carolina Chapel Hill School of Medicine are recruiting individuals who have had receptive anal intercourse in the last 3 months to test a rectal douche with tenofovir as compared to a pill that prevents HIV.

Fast Facts

Ages 18+ and Assigned Male at Birth

Engaged in Receptive Anal Intercourse in the Last 3 Months

Compensation Provided

Conducted in Chapel Hill, NC

Study Background

Researchers at University of North Carolina Chapel Hill are looking for individuals who have had receptive anal sex in the last 3 months to assess the safety and acceptability of a rectal douche for HIV prevention.

The REV UP study is designed to evaluate the safety and use of a TFV douche as compared to on-demand oral F/TDF (a PrEP pill). Researchers aim to facilitate expanded choices for PrEP options, especially by incorporating HIV prevention methods into a product already in use, like a rectal douche.

Participants will be randomized to receive either the rectal douche or an oral pill for HIV prevention. Each product will be used for 8 weeks with a 2 to 4-week washout period in between.



Study Background

Researchers at University of North Carolina Chapel Hill are looking for individuals who have had receptive anal sex in the last 3 months to assess the safety and acceptability of a rectal douche for HIV prevention.

The REV UP study is designed to evaluate the safety and use of a TFV douche as compared to on-demand oral F/TDF (a PrEP pill). Researchers aim to facilitate expanded choices for PrEP options, especially by incorporating HIV prevention methods into a product already in use, like a rectal douche.

Participants will be randomized to receive either the rectal douche or an oral pill for HIV prevention. Each product will be used for 8 weeks with a 2 to 4-week washout period in between.

 

Additional Information

This study is being conducted to evaluate the acceptability of on-demand rectal tenofovir douches compared to the on-demand PrEP pill.

You may qualify for this study if you meet the following criteria.

Inclusion Criteria:

  • Ages 18+
  • Assigned male at birth
  • Engaged in receptive anal intercourse in the last 3 months
  • Used an enema or rectal douche more than half the time before having anal sex in the past year
  • No diagnosis of HIV or Hepatitis B
  • No use of HIV prevention medication (PrEP) in the last 8 weeks

For this study, participants can expect to have around 7 in-person visits, which will all take place within a window of about 18 weeks, and an end of study phone call in the 19th week.

As a participant in the study, you will be asked to utilize each study product for 8 weeks and reflect on your experiences using the products. The order in which you use the products will be assigned randomly. You will be asked to keep an electronic diary and discuss your experiences with the products with a staff member.

During the study visits, research team members will collect your health information, vital signs, and a blood draw.

Participants will receive the following in compensation, totaling up to $1,256:

  • $75 for each in-person visit and the end of study phone call
  • $3 per daily survey
  • A $20 bonus for each week that the participant completes at least 6 of the 7 daily surveys

There is no cost for you to participate in our research study.

Meet The Principal Investigator

Christopher Hurt MD, FIDSA

University of North Carolina at Chapel Hill (UNC)

Christopher B. Hurt, MD is an Associate Professor of Medicine in the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill (UNC). His clinical expertise is in the treatment and prevention of HIV, hepatitis C, and sexually transmitted infections.

Find out more about this study:

NCT#: NCT06560684

Previous publications can be found here.