{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T16:02:11Z","timestamp":1794326531790,"version":"4.9.0"},"reference-count":20,"publisher":"BMJ","issue":"1","funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["P30AI094189"],"award-info":[{"award-number":["P30AI094189"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["T32 GM066691"],"award-info":[{"award-number":["T32 GM066691"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["U19 AI113127"],"award-info":[{"award-number":["U19 AI113127"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000025","name":"National Institute of Mental Health","doi-asserted-by":"publisher","award":["P30-MH43520"],"award-info":[{"award-number":["P30-MH43520"]}],"id":[{"id":"10.13039\/100000025","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Sex Transm Infect"],"accepted":{"date-parts":[[2024,8,18]]},"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>DREAM-01 was an open label, dose-escalation and variable osmolarity study to identify a tenofovir HIV-prevention douche\/enema that could achieve protective colon tissue cell concentrations and high acceptability. To assess impact on sexual enjoyment, iso-osmolar and hypo-osmolar placebo douches were provided for at-home use before receptive anal sex (RAS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Eighteen HIV-uninfected men who have RAS were administered three tenofovir douches at the research clinic: Product A, an iso-osmolar dose; Product B, an iso-osmolar escalation dose; and Product C, a hypo-osmolar escalation dose. Following Products A and C, participants were given a saline douche of matching osmolarity to use at home before RAS. Participants reported acceptability via a computer-assisted self-interview and in-depth interview in this mixed-methods study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>All three products were rated acceptable by 17 (95%) of the participants. A majority (94%) would be likely or very likely to use any of the three products before RAS. Of those who used the saline douches before RAS and then rated their sexual enjoyment, most reported that their sexual enjoyment was not affected. Interview data revealed that participants found the product easy to incorporate into their regular routine, but would prefer to use more liquid for cleansing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These findings indicate that the hypo-osmolar Product C, which also provides the most rapid delivery of tenofovir for HIV prevention, is acceptable for future safety trials and that our sample reports high likelihood of using a rectal microbicide douche for HIV prevention. Our findings support continued pursuit of a tenofovir rectal microbicide douche.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02750540\">NCT02750540<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/sextrans-2024-056209","type":"journal-article","created":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T17:21:07Z","timestamp":1725556867000},"page":"49-54","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Acceptability of a rectal microbicide douche for HIV prevention: a mixed-methods analysis of a first-in-human formulation pilot study"],"prefix":"10.1136","volume":"101","clinical-trial-number":[{"clinical-trial-number":"nct02750540","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6529-0550","authenticated-orcid":false,"given":"Rebecca","family":"Giguere","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iv\u00e1n C","family":"Bal\u00e1n","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cody","family":"Lentz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Curtis","family":"Dolezal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Carballo-Di\u00e9guez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward J","family":"Fuchs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Anton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"McGowan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Ho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ethel","family":"Weld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Craig W","family":"Hendrix","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,9,5]]},"reference":[{"key":"2025012910100558000_101.1.49.1","doi-asserted-by":"publisher","DOI":"10.1136\/sti.2008.030478"},{"key":"2025012910100558000_101.1.49.2","doi-asserted-by":"crossref","first-page":"S66","DOI":"10.1007\/s10461-011-9899-9","article-title":"Rectal microbicides: can we make them and will people use them?","volume":"15 Suppl 1","author":"McGowan","year":"2011","journal-title":"AIDS Behav"},{"key":"2025012910100558000_101.1.49.3","unstructured":"Pickett J . Ready, set, rectal microbicides: an update on rectal microbicide research and advocacy. Available: https:\/\/pdf.usaid.gov\/pdf_docs\/PA00JKZ1.pdf [Accessed 11 Feb 2023]."},{"key":"2025012910100558000_101.1.49.4","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0181607","article-title":"High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women","volume":"12","author":"Carballo-Di\u00e9guez","year":"2017","journal-title":"PLoS One"},{"key":"2025012910100558000_101.1.49.5","doi-asserted-by":"publisher","DOI":"10.1007\/s10461-018-2336-6"},{"key":"2025012910100558000_101.1.49.6","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-2667(21)00112-2"},{"key":"2025012910100558000_101.1.49.7","doi-asserted-by":"publisher","DOI":"10.1007\/s10461-017-1959-3"},{"key":"2025012910100558000_101.1.49.8","unstructured":"Giguere R , Carballo-Dieguez A , Lentz C , et al . The potential for a rectal microbicide douche: findings from an international survey. Poster presentation at CROI 2020 Virtual Conference; 2020"},{"key":"2025012910100558000_101.1.49.9","doi-asserted-by":"publisher","DOI":"10.1089\/aid.2012.0262"},{"key":"2025012910100558000_101.1.49.10","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0060147","article-title":"A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007)","volume":"8","author":"McGowan","year":"2013","journal-title":"PLoS One"},{"key":"2025012910100558000_101.1.49.11","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiad535"},{"key":"2025012910100558000_101.1.49.12","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciw832"},{"key":"2025012910100558000_101.1.49.13","unstructured":"Zheng R , Ho K , Fuchs EJ , et al . Safety and PK\/PD of a tenofovir rectal douche administered in different sequences (dream-03). Poster presentation at the 2024 Conference on Retroviruses and Opportunistic Infections; 2024"},{"key":"2025012910100558000_101.1.49.14","doi-asserted-by":"crossref","unstructured":"Diniz C . Tenofovir douche as HIV pre-exposure prophylaxis for receptive anal intercourse: end user feasibility evaluation of tenofovir rectal microbicide douche (dream-04). Poster AS-AIDS-2024-03352. AIDS 2024 Conference; 2024","DOI":"10.1097\/QAI.0000000000003608"},{"key":"2025012910100558000_101.1.49.15","doi-asserted-by":"publisher","DOI":"10.1007\/s10461-019-02662-x"},{"key":"2025012910100558000_101.1.49.16","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0284339","article-title":"A randomized trial of safety, acceptability and adherence of three rectal microbicide placebo formulations among young sexual and gender minorities who engage in receptive anal intercourse (MTN-035)","volume":"18","author":"Bauermeister","year":"2023","journal-title":"PLoS ONE"},{"key":"2025012910100558000_101.1.49.17","doi-asserted-by":"publisher","DOI":"10.1007\/s10461-024-04360-9"},{"key":"2025012910100558000_101.1.49.18","doi-asserted-by":"crossref","DOI":"10.1002\/jia2.26096","article-title":"Who prefers what? Correlates of preferences for next-generation HIV prevention products among a national U.S. sample of young men who have sex with men","volume":"26 Suppl 2","author":"Biello","year":"2023","journal-title":"J Int AIDS Soc"},{"key":"2025012910100558000_101.1.49.19","doi-asserted-by":"crossref","unstructured":"Tagliaferri Rael C , Giguere R , Bryndza Tfaily E , et al . The Global Impact of Diversifying PrEP Options: Results of an International Discrete Choice Experiment of Existing and Potential PrEP Strategies with Gay and Bisexual Men and Physicians. AIDS Res Hum Retroviruses 2024. doi:10.1089\/AID.2023.0120","DOI":"10.1089\/aid.2023.0120"},{"key":"2025012910100558000_101.1.49.20","unstructured":"HTPN 106: a phase 2 crossover study of on demand PrEP formulations comparing rectal and oral TFV-based PrEP evaluating extended safety, acceptability and PK\/PD. Study summary. 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