A clinical trial, sponsored by the National Institutes of Health (NIH), has commenced to evaluate the safety and acceptability of a rectal HIV microbicide douche containing the antiretroviral drug tenofovir. This "on-demand" approach to HIV prevention is designed for use prior to potential exposure during receptive anal intercourse.
Trial Design and Objectives
The clinical trial, known as HPTN 106 (NCT06560684), will enroll approximately 150 adult men assigned male at birth who regularly use unmedicated rectal douches before receptive anal intercourse. Participants will undergo two two-month periods, one using the on-demand tenofovir rectal microbicide douche and the other using on-demand oral PrEP with tenofovir disoproxil fumarate and emtricitabine. Throughout the study, participants will be closely monitored for safety, acceptability, adherence, and method preference.
The study will take place at eight sites across the United States.
Addressing Unmet Needs in HIV Prevention
While HIV incidence is slowly decreasing in the United States, a significant proportion of new diagnoses (67% from 2018-2022) occur among gay, bisexual, and other men who have sex with men. This highlights the need for diverse HIV prevention strategies. Current PrEP options include daily oral pills, long-acting injections, and a monthly vaginal ring. While the CDC advises on-demand oral PrEP for specific populations, rectal microbicides offer another potential on-demand option to expand choices for those engaging in receptive anal intercourse.
Expert Commentary
Sheryl Zwerski, D.N.P., director of the Prevention Sciences Program in NIAID’s Division of AIDS, is available to discuss this research.
The mid-stage study is sponsored by NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and implemented through the NIH-funded HIV Prevention Trials Network (HPTN). NIH remains committed to developing safe and effective HIV prevention methods that people need, want, and are able to use.
