Feasibility of an Oral Intervention for Sexual Health in Transgender Men

Transgender men (TGM) have a higher risk of sexually transmitted infections (STIs) associated with vaginal dysbiosis, such as HIV, HPV and bacterial N. gonorrhea and C. trachomatis compared to cisgender women (CGW). TGM on testosterone therapy (TT) also have increased vaginal symptoms. Vaginal dysbiosis can be characterized as clinical-BV or molecular-BV (i.e. based on vaginal microbiota profile). Both are known contributors to increased vaginal symptoms and STI risk in CGW. Low Lactobacillus (LL) levels determine molecular-BV and clinical-BV. Studies show that TGM on TT show that they have a primarily LL vaginal microbiota. The investigators are planning a future study to test the efficacy of an oral Lactobacillus probiotic to improve vaginal health. The goal for the future study is to test an intervention that the investigators hypothesize may be able to ameliorate some of the adverse health outcomes observed in TGM on TT. Thus, the investigators propose to use an intervention of a mixture of two components: 1) the probiotic Lactobacillus acidophilus GLA14 and 2) the probiotic Lactobacillus rhamnosus HN001. Studies have shown that an oral combination of this intervention increases vaginal Lactobacillus levels and improves vaginal health in CGW. The future study will test whether this intervention is effective in TGM on TT. This specific study is a pilot study to be conducted prior to the future study detailed above. Here, the investigators will randomize 30 TGM on TT to receive the intervention or placebo for 4 weeks. The intervention in the pilot study will be the same as the intervention of the main trial and will consist of the probiotics 1) Lactobacillus acidophilus GLA-14 and 2) Lactobacillus rhamnosus HN001. The placebo will be maltodextrin, the same as the proposed larger study. The investigators will assess the effect of the intervention on clinical-BV, molecular-BV (based on vaginal microbiota) and other clinical outcomes. Further, the investigators will determine the feasibility, acceptability, and adherence of the intervention. The investigators will conduct the pilot study at the CLCHC Brooklyn site. This pilot study will allow us to generate preliminary data, determine the feasibility and acceptability, and plan appropriately for the future study.