PMID- 27362788 OWN - NLM STAT- MEDLINE DCOM- 20170726 LR - 20181113 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 11 IP - 6 DP - 2016 TI - Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women. PG - e0158310 LID - 10.1371/journal.pone.0158310 [doi] LID - e0158310 AB - OBJECTIVES: The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection. METHODS: MSM and TGW aged 18-30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel. RESULTS: 248 participants were enrolled into Stage 1A. Participants' average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity. CONCLUSIONS: In this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT01283360. FAU - McGowan, Ian AU - McGowan I AUID- ORCID: 0000-0002-6470-8476 AD - University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America. AD - Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America. FAU - Cranston, Ross D AU - Cranston RD AD - University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America. FAU - Mayer, Kenneth H AU - Mayer KH AD - Fenway Institute, Fenway Health, Boston, Massachusetts, United States of America. AD - Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America. FAU - Febo, Irma AU - Febo I AD - University of Puerto Rico Medical Sciences Campus, Department of Pediatrics, Gama Project, San Juan, Puerto Rico. FAU - Duffill, Kathryn AU - Duffill K AD - Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America. FAU - Siegel, Aaron AU - Siegel A AD - Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America. FAU - Engstrom, Jarret C AU - Engstrom JC AD - Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America. FAU - Nikiforov, Alexyi AU - Nikiforov A AD - Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America. FAU - Park, Seo-Young AU - Park SY AD - University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America. FAU - Brand, Rhonda M AU - Brand RM AD - University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America. AD - Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America. FAU - Jacobson, Cindy AU - Jacobson C AD - Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America. FAU - Giguere, Rebecca AU - Giguere R AD - Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America. FAU - Dolezal, Curtis AU - Dolezal C AD - Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America. FAU - Frasca, Timothy AU - Frasca T AD - Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America. FAU - Leu, Cheng-Shiun AU - Leu CS AD - Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America. FAU - Schwartz, Jill L AU - Schwartz JL AD - CONRAD, Arlington, Virginia, United States of America. FAU - Carballo-Dieguez, Alex AU - Carballo-Dieguez A AD - Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America. LA - eng SI - ClinicalTrials.gov/NCT01283360 GR - P30 MH043520/MH/NIMH NIH HHS/United States GR - R01 HD059533/HD/NICHD NIH HHS/United States GR - UM1 AI069415/AI/NIAID NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial DEP - 20160630 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Anti-HIV Agents) RN - 0 (Gels) RN - 99YXE507IL (Tenofovir) SB - IM MH - Administration, Rectal MH - Adolescent MH - Adult MH - Anti-HIV Agents/*administration & dosage/adverse effects MH - Chlamydia Infections/complications/epidemiology MH - Cross-Sectional Studies MH - Female MH - Gels MH - HIV Infections/epidemiology/*prevention & control MH - Herpes Genitalis/complications/epidemiology MH - Homosexuality, Male MH - Humans MH - Male MH - Sexually Transmitted Diseases/complications/*epidemiology MH - Tenofovir/*administration & dosage/adverse effects MH - Transgender Persons MH - Young Adult PMC - PMC4928823 COIS- Competing Interests: The authors of this manuscript have read the journal's policy and have the following competing interests: IM is a consultant for Novicol Life Science Inc., who have a surfactant microbicide in preclinical development. RDC is the husband of IM and is therefore potentially conflicted by nature of his relationship with IM. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials. EDAT- 2016/07/01 06:00 MHDA- 2017/07/27 06:00 PMCR- 2016/06/30 CRDT- 2016/07/01 06:00 PHST- 2016/02/16 00:00 [received] PHST- 2016/06/13 00:00 [accepted] PHST- 2016/07/01 06:00 [entrez] PHST- 2016/07/01 06:00 [pubmed] PHST- 2017/07/27 06:00 [medline] PHST- 2016/06/30 00:00 [pmc-release] AID - PONE-D-16-06560 [pii] AID - 10.1371/journal.pone.0158310 [doi] PST - epublish SO - PLoS One. 2016 Jun 30;11(6):e0158310. doi: 10.1371/journal.pone.0158310. eCollection 2016.