Show simple item record

dc.contributor.authorMcGowan, Ianen_US
dc.contributor.authorCranston, Ross D.en_US
dc.contributor.authorMayer, Kenneth H.en_US
dc.contributor.authorFebo, Irmaen_US
dc.contributor.authorDuffill, Kathrynen_US
dc.contributor.authorSiegel, Aaronen_US
dc.contributor.authorEngstrom, Jarret C.en_US
dc.contributor.authorNikiforov, Alexyien_US
dc.contributor.authorPark, Seo-Youngen_US
dc.contributor.authorBrand, Rhonda M.en_US
dc.contributor.authorJacobson, Cindyen_US
dc.contributor.authorGiguere, Rebeccaen_US
dc.contributor.authorDolezal, Curtisen_US
dc.contributor.authorFrasca, Timothyen_US
dc.contributor.authorLeu, Cheng-Shiunen_US
dc.contributor.authorSchwartz, Jill L.en_US
dc.contributor.authorCarballo-Diéguez, Alexen_US
dc.date.accessioned2016-08-09T14:54:50Z
dc.date.issued2016en_US
dc.identifier.citationMcGowan, I., R. D. Cranston, K. H. Mayer, I. Febo, K. Duffill, A. Siegel, J. C. Engstrom, et al. 2016. “Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women.” PLoS ONE 11 (6): e0158310. doi:10.1371/journal.pone.0158310. http://dx.doi.org/10.1371/journal.pone.0158310.en
dc.identifier.issn1932-6203en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:27822381
dc.description.abstractObjectives: 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 NCT01283360en
dc.language.isoen_USen
dc.publisherPublic Library of Scienceen
dc.relation.isversionofdoi:10.1371/journal.pone.0158310en
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4928823/pdf/en
dash.licenseLAAen_US
dc.subjectBiology and Life Sciencesen
dc.subjectMicrobiologyen
dc.subjectMicrobial Controlen
dc.subjectMicrobicidesen
dc.subjectPeople and Placesen
dc.subjectPopulation Groupingsen
dc.subjectSexual Preferencesen
dc.subjectMen WHO Have Sex with Menen
dc.subjectMedicine and Health Sciencesen
dc.subjectInfectious Diseasesen
dc.subjectSexually Transmitted Diseasesen
dc.subjectMedicine and health sciencesen
dc.subjectInfectious diseasesen
dc.subjectViral diseasesen
dc.subjectHIV infectionsen
dc.subjectPublic and occupational healthen
dc.subjectPreventive medicineen
dc.subjectHIV preventionen
dc.subjectProfessionsen
dc.subjectSex Workersen
dc.subjectMedical Microbiologyen
dc.subjectMicrobial Pathogensen
dc.subjectViral Pathogensen
dc.subjectImmunodeficiency Virusesen
dc.subjectHIVen
dc.subjectPathology and Laboratory Medicineen
dc.subjectPathogensen
dc.subjectOrganismsen
dc.subjectVirusesen
dc.subjectBiology and life sciencesen
dc.subjectRNA virusesen
dc.subjectRetrovirusesen
dc.subjectLentivirusen
dc.subjectClinical Research Designen
dc.subjectAdverse Eventsen
dc.titleProject Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Womenen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalPLoS ONEen
dash.depositing.authorMayer, Kenneth H.en_US
dc.date.available2016-08-09T14:54:50Z
dc.identifier.doi10.1371/journal.pone.0158310*
dash.authorsorderedfalse
dash.contributor.affiliatedMayer, Kenneth
dc.identifier.orcid0000-0001-7460-733X


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record