Inclusion criteria
inflammatory bowel disease or anorectal condition
REPRODUCTIVE TRACT INFECTION, URINARY TRACT INFECTION
Inclusion criteria included: 1) men (cis or transgender) and transgender women between 18–35 years old; 2) ability and willingness to provide written informed consent in local language; 3) HIV- 1/2 uninfected at Screening and Enrollment; 4) ability and willingness to provide adequate contact and location information; 5) availability to return for all study visits and willingness to comply with study participation requirements; 6) deemed to be in general good health by a healthcare provider at Screening and Enrollment; 7) a reported history of consensual RAI at least three times in the past three months and expectation to maintain at least that frequency of RAI during study participation; 8) willingness to not take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation; 9) For individuals who could get pregnant (transgender men with a female reproductive system), a negative pregnancy test at Screening and Enrollment; 10) For individuals who could get pregnant, use of an effective method of contraception for at least 30 days (inclusive) prior to Enrollment, and intention to use an effective method for the duration of study participation. Exclusion criteria included history of inflammatory bowel disease or anorectal condition impeding product placement or assessment of tolerability; anticipated use of non-study rectally administered products; any prior participation in research studies involving rectal products; having an active anorectal or reproductive tract infection requiring treatment or symptomatic urinary tract infection (these participants could be retested during screening and could enroll if resolved); and pregnancy or breast-feeding.