Study Summary:

The purpose of the overall study is to ensure the inclusion of adolescent and young adults’ perspectives as next generation biomedical prevention, specifically a rectal douche (TFV microbicide; 660mg TFV in 125mL half-normal saline), during its clinical testing and development for safety and efficacy.  

We will recruit YMSM who have expressed interest in being contacted to screen for eligibility into a Phase I HIV prevention biomedical trial. We expect to initially screen 48 YMSM living in the greater Baltimore Metropolitan Area to enroll 16 evaluable participants. YMSM who are willing and cleared to participate in the Trial visit will be re–consented and asked to use a single dose of the TFV douche at the Hopkins study site. Prior to using the douche, baseline samples (see Appendix 1) will be collected to establish pre-dose conditions for safety assessments as well as sample collection for TFV analyte concentration in multiple matrices for participants taking oral TDF/FTC PrEP. These concentrations will be used to adjust post-dose PK and PD assessments. Participants will also complete a post-dose survey and an in-depth interview (IDI) regarding product acceptability and experiences participating in the study at their termination visit. 

As a second aim of this protocol, we will also conduct in-depth interviews with individuals who choose not to participate in the Phase I Safety Trial or who were not eligible after medical screening (N=32) in order to examine perceived barriers and facilitators to their willingness to participate in biomedical trials, and examine their suggestions to maximize YMSM’s engagement in future biomedical trials.  

Study Details:

Study Duration:

Accrual is expected to be complete within approximately 9 months. Each participant will be on study for approximately 2-3 months. The total duration of the study will be approximately 1 year.

Sample Size:

We will recruit 48 YMSM who gave permission to be contacted and expressed initial interest in an in-person Screening Visit. These 48 YMSM come from a larger online survey (n=500) focused on YMSM’s willingness to participate in biomedical trials. We will then aim to screen and consent approximately 48 YMSM in-person to enroll 16 YMSM for the Phase I Safety Trial.  

Eligibility Criteria:

Includes, but not limited to:

  • Between the ages of 15-24 at screening  
  • Cisgender male who has sex with other men  
  • Participant demonstrates capacity to comprehend, evaluate, reason, and express a choice about their participation in study  
  • For youth ages 15-17, have parent or caregiver consent to take part in the study 
  • Express initial interest in participating in a douching study  
  • Understand and agree to local HIV/STI reporting requirements  
  • HIV-1 uninfected at screening as documented by Combo Ag/Ab HIV- 1/HIV-2 immunoassay  
  • Willingness and availability to attend all study visits, barring unforeseen circumstances  
  • Per participant report at screening, consensual RAI in prior 6 months  
  • Live in or around the Baltimore area.   
  • Agrees not to participate in other research studies involving drugs and/ or medical devices for the study’s duration  

Primary Objectives:

  1. Acceptability: To describe YMSM’s acceptability of a novel HIV prevention douche, prior to and after using a one-time dose of the Product C douche. 
  2. Pharmacokinetics: To quantify the colonic tissue cell TFV-DP concentration following TFV douche administration among YMSM 
  3. Safety: To assess safety of the TFV douche product and quantify any association with clinical toxicity or adverse events 

Protocol Chairs:

José Bauermeister, PhD, MPH
Craig Hendrix, MD