Introduction
enema
STIS, SEXUALLY TRANSMITTED INFECTIONS
The HIV epidemic has affected people across the globe over the past four decades, with sexual and gender minorities (SGM; i.e., populations with same-sex or same-gender attractions or behaviors and who may identify with a non-heterosexual identity such as gay, bisexual, queer, etc.)carrying much of the burden of new diagnoses [Researchers and advocates have proposed expanding modalities of PrEP delivery, including the use of rectal microbicides (RMs); topical biomedical products being developed to reduce the risk of HIV and other sexually transmitted infections (STIs) for use with sexual activity [Most rectal microbicide candidates have been formulated as gels because of their similarities to lubricants, highlighting the potential for the rectal microbicide gel to be readily incorporated into users’ sexual practices [Survey research with SGM populations across various countries has found high hypothetical acceptability to a rectal microbicide formulated as a suppository, insert, or enema [The primary objectives of MTN-035 were to evaluate the acceptability and safety of and adherence to three placebo modalities–an insert, a suppository, and an enema–that could be used prior to RAI in a randomized, cross-over trial. We hypothesized that all three modalities would be acceptable and safe for use prior to RAI, and that SGM participants would report high adherence to these modalities given their behavioral congruence with cleansing practices (e.g., enemas) and their familiar use to deliver medications (e.g., suppositories; fast-dissolving inserts) via the rectum.