HIV Prevention Research Study

Researchers at Johns Hopkins University 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

Males Ages 18+

Engaged in Receptive Anal Intercourse in the Last 3 Months

Compensation Provided

Conducted in Baltimore, MD

Study Background

COMPARING RECTAL AND ORAL TENOFOVIR-BASED PREP

A Phase 2 Crossover Study of On-Demand Prep Formulations Comparing Rectal and Oral Tenofovir-based Prep Evaluating Extended Safety, Acceptability, and Pharmacokinetics/Pharmacodynamics

Study Overview:

  • Purpose: Compare the safety and acceptability of a tenofovir rectal douche vs. tenofovir/emtricitabine pill (e.g., Truvada™) for HIV prevention.
  • Eligibility: People who have used a rectal douche or enema before receptive anal sex.

Study Details:

  • Duration: ~20 weeks
  • Visits: ~8 in-person visits + extra for some participants in optional sub-study (if interested)
  • Tasks: Use each product for 8 weeks and share your experience.

Join Us: Help advance HIV prevention research—enroll today!

Study Background

COMPARING RECTAL AND ORAL TENOFOVIR-BASED PREP

Study Overview:

  • Purpose: Compare the safety and acceptability of a tenofovir rectal douche vs. tenofovir/emtricitabine pill (e.g., Truvada™) for HIV prevention.
  • Eligibility: People who have used a rectal douche or enema before receptive anal sex.

Study Details:

  • Duration: ~20 weeks
  • Visits: ~8 in-person visits + extra for some participants in optional sub-study (if interested)
  • Tasks: Use each product for 8 weeks and share your experience.

Join Us: Help advance HIV prevention research—enroll today!

Additional Information

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

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

Inclusion Criteria:

  • Males ages 18+
  • 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
  • Not HIV positive
  • No use of HIV prevention medication (PrEP) in the last 8 weeks

For this study, participants can expect to have around 8 in-person visits, which will all take place within a window of about 20 weeks. 

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.

You may be asked to provide blood and urine samples during your visits and you may also have a rectal or throat swab collected by a trained staff member. 

For some participants eligible for the small, optional sub-study, you can expect 7 additional visits, two of which will last around 6 hours. 3 of the additional visits will include a flexible sigmoidoscopy procedure where rectal biopsies are collected.

You can earn up to $1025 for completing the main study; some participants may earn up to $950 more for a substudy. 

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