Background : Transgender people who engage in anal sex need HIV prevention options that they desire to use. While oral Truvada as pre-exposure prophylaxis (PrEP) is a safe and very effective method to prevent HIV, daily pill taking is not desirable for everyone. Additional HIV prevention options are needed to address the complexity of sex, human nature, pleasure and HIV. Rectal microbicides – formulated as douches, fast-dissolving rectal tablets and suppositories – are being developed and tested to provide additional options to reduce the risk of HIV from anal sex, and may fulfill the need for a non-systemic, short-acting product that can be used by transgender people around the time of sexual activity.
Methods : MTN-035, or DESIRE (Developing and Evaluating Short-acting Innovations for REctal use) is the first study to systematically examine the acceptability, tolerability and adherence of three placebo rectal microbicide formulations in a sample of young transgender men and women and cisgender men who have sex with men. The study seeks to:
• compare and contrast modalities based on product characteristics and participants’ characteristics and contexts
• assess modality acceptability and tolerability, including best practices learn from participants’ experiences
Results : Previous rectal microbicide studies, such as MTN-017, whose results were reported at CROI in 2016, have demonstrated that douching is a common practice among transgender people in preparation for anal sex. Through studies like DESIRE, we hope to better understand:
• The context of transgender study participants’ lives & their desire to use a particular product
• What factors may influence transgender people to continue to want to use a particular product
• How we make a product that is easy to use and conforms to a participant's way of life and anal sex practices
Conclusions : Rectal microbicides may have biological and behavioral advantages over oral PrEP or other systemic approaches by achieving high drug concentrations in local tissue and linking prevention to behaviors that transgender people already engage in around anal sex. As a unique study design, DESIRE embodies an approach to HIV prevention that appreciates the spontaneous and pleasurable practice of anal sex, and one that seeks to accommodate different social and structural circumstances among peoples’ lives. It will also help us design HIV prevention products that fit into the lives of transgender people, rather than expecting their lives to fit into standard prevention modalities.