{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,14]],"date-time":"2026-06-14T17:12:22Z","timestamp":1781457142240,"version":"3.54.1"},"reference-count":26,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,3,25]],"date-time":"2025-03-25T00:00:00Z","timestamp":1742860800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Reprod. Health"],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Live biotherapeutic products (LBPs) containing <jats:italic>Lactobacillus crispatus<\/jats:italic> may optimize the vaginal microbiota, reduce genital inflammation, and protect against HIV acquisition. Determining acceptability of LBPs among African women at high risk of HIV is essential to guide product development.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The phase 2 double-blind randomized placebo-controlled trial recruited young sexually active cis-women with vaginal dysbiosis from a community-based research clinic. Following antibiotics (oral metronidazole), participants were randomized (2:1) to receive 11 doses of LACTIN-V (2\u2009\u00d7\u200910<jats:sup>9<\/jats:sup> L<jats:italic>. crispatus<\/jats:italic> CTV-05) or placebo over 4 weeks. A questionnaire assessed product acceptability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Forty-five young Black South African women were randomized to LACTIN-V (<jats:italic>N<\/jats:italic>\u2009=\u200932) or placebo (<jats:italic>N<\/jats:italic>\u2009=\u200913). Forty-two (93.3%) had an active sexual partner. Adherence was high with 36 participants (80.0%) completing all 11 doses. Of the 43 participants who completed the acceptability questionnaire, 38 (88.4%) were satisfied using the vaginal applicator and 41 (95.5%) confirmed ease of use. For 14 (32.5%) participants, product use without the partner knowing was important. Thirty-one (72.1%) participants felt that partner approval for product use was not important. On Likert scales of 0\u201310 (lowest to highest), agreement with positive product attributes (effective, comfortable, easy to use) scored at means of\u2009 \u22656.7. Negative product attributes (dosing, leakage, vaginal dryness, partner's disapproval) were rated less important with lower mean scores \u22643.2. Overall, 75% of participants would use the product again, with no significant difference between study arms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Young South African women at high risk of HIV found the LACTIN-V study product highly acceptable and easy to use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p>[<jats:uri>clinicaltrials.gov<\/jats:uri>], identifier [NCT05022212].<\/jats:p><\/jats:sec>","DOI":"10.3389\/frph.2025.1544458","type":"journal-article","created":{"date-parts":[[2025,3,25]],"date-time":"2025-03-25T23:36:47Z","timestamp":1742945807000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Acceptability of the live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) among young women at high risk of HIV acquisition in South Africa: data from the phase 2 placebo-controlled trial"],"prefix":"10.3389","volume":"7","author":[{"given":"A.","family":"Hemmerling","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Govender","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Dong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Dong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sooseela","family":"Pillay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Ndung\u2019u","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Bhoola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Moodley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Casillas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Lagenaur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. M.","family":"Mitchell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D. S.","family":"Kwon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. R.","family":"Cohen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,3,25]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1016\/j.immuni.2016.12.013","article-title":"Lactobacillus-deficient cervicovaginal bacterial communities are associated with increased HIV acquisition in young South African women","volume":"46","author":"Gosmann","year":"2017","journal-title":"Immunity"},{"key":"B2","doi-asserted-by":"publisher","first-page":"554","DOI":"10.1016\/S1473-3099(18)30058-6","article-title":"Evaluation of the association between the concentrations of key vaginal bacteria and the increased risk of HIV acquisition in African women from five cohorts: a nested case-control study","volume":"18","author":"McClelland","year":"2018","journal-title":"Lancet Infect Dis"},{"key":"B3","doi-asserted-by":"publisher","first-page":"e1002511","DOI":"10.1371\/journal.pmed.1002511","article-title":"Prevalence of sexually transmitted infections and bacterial vaginosis among women in sub-Saharan Africa: an individual participant data meta-analysis of 18 HIV prevention studies","volume":"15","author":"Torrone","year":"2018","journal-title":"PLoS Med"},{"key":"B4","doi-asserted-by":"publisher","first-page":"965","DOI":"10.1016\/j.immuni.2015.04.019","article-title":"Cervicovaginal bacteria are a major modulator of host inflammatory responses in the female genital tract","volume":"42","author":"Anahtar","year":"2015","journal-title":"Immunity"},{"key":"B5","doi-asserted-by":"publisher","first-page":"11974","DOI":"10.1038\/s41598-017-12198-6","article-title":"A longitudinal analysis of the vaginal microbiota and vaginal immune mediators in women from sub-Saharan Africa","volume":"7","author":"Jespers","year":"2017","journal-title":"Sci Rep"},{"key":"B6","doi-asserted-by":"publisher","first-page":"e00410-17","DOI":"10.1128\/IAI.00410-17","article-title":"Microbial composition predicts genital tract inflammation and persistent bacterial vaginosis in South African adolescent females","volume":"86","author":"Lennard","year":"2017","journal-title":"Infect Immun"},{"key":"B7","doi-asserted-by":"publisher","first-page":"1012","DOI":"10.1038\/s41591-019-0450-2","article-title":"The vaginal microbiome and preterm birth","volume":"25","author":"Fettweis","year":"2019","journal-title":"Nat Med"},{"key":"B8","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1111\/1471-0528.15854","article-title":"The vaginal microbiota, human papillomavirus and cervical dysplasia: a systematic review and network meta-analysis","volume":"127","author":"Norenhag","year":"2020","journal-title":"BJOG"},{"key":"B9","doi-asserted-by":"publisher","first-page":"1478","DOI":"10.1086\/503780","article-title":"High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence","volume":"193","author":"Bradshaw","year":"2006","journal-title":"J Infect Dis"},{"key":"B10","doi-asserted-by":"publisher","first-page":"500","DOI":"10.3390\/antibiotics11040500","article-title":"The role of antimicrobial resistance in refractory and recurrent bacterial vaginosis and current recommendations for treatment","volume":"11","author":"Muzny","year":"2022","journal-title":"Antibiotics (Basel)"},{"key":"B11","doi-asserted-by":"publisher","first-page":"45","DOI":"10.3920\/BM2022.0084","article-title":"Safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) in pregnant women at high-risk of preterm birth","volume":"14","author":"Bayar","year":"2023","journal-title":"Benef Microbes"},{"key":"B12","doi-asserted-by":"publisher","first-page":"564","DOI":"10.1097\/OLQ.0b013e3181a74924","article-title":"Phase 1 dose-ranging safety trial of Lactobacillus crispatus CTV-05 for the prevention of bacterial vaginosis","volume":"36","author":"Hemmerling","year":"2009","journal-title":"Sex Transm Dis"},{"key":"B13","doi-asserted-by":"publisher","first-page":"745","DOI":"10.1097\/OLQ.0b013e3181e50026","article-title":"Phase 2a study assessing colonization efficiency, safety, and acceptability of Lactobacillus crispatus CTV-05 in women with bacterial vaginosis","volume":"37","author":"Hemmerling","year":"2010","journal-title":"Sex Transm Dis"},{"key":"B14","doi-asserted-by":"publisher","first-page":"1906","DOI":"10.1056\/NEJMoa1915254","article-title":"Randomized trial of Lactin-V to prevent recurrence of bacterial vaginosis","volume":"382","author":"Cohen","year":"2020","journal-title":"N Engl J Med"},{"key":"B15","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1186\/s12879-020-05210-4","article-title":"Testing the regulatory framework in South Africa\u2014a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis","volume":"20","author":"Happel","year":"2020","journal-title":"BMC Infect Dis"},{"key":"B16","doi-asserted-by":"publisher","first-page":"e031819","DOI":"10.1136\/bmjopen-2019-031819","article-title":"Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach","volume":"10","author":"Verwijs","year":"2020","journal-title":"BMJ Open"},{"key":"B17","doi-asserted-by":"publisher","first-page":"509","DOI":"10.1056\/NEJMoa1402269","article-title":"Tenofovir-based preexposure prophylaxis for HIV infection among African women","volume":"372","author":"Marrazzo","year":"2015","journal-title":"N Engl J Med"},{"key":"B18","doi-asserted-by":"publisher","first-page":"411","DOI":"10.1056\/NEJMoa1202614","article-title":"Preexposure prophylaxis for HIV infection among African women","volume":"367","author":"Van Damme","year":"2012","journal-title":"N Engl J Med"},{"key":"B19","doi-asserted-by":"publisher","first-page":"149","DOI":"10.1016\/S2055-6640(20)30458-1","article-title":"HIV pre-exposure prophylaxis for women","volume":"2","author":"Sheth","year":"2016","journal-title":"J Virus Erad"},{"key":"B20","article-title":"Effect of the vaginal live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) on vaginal microbiota and genital tract inflammation among women at high risk of HIV acquisition in South Africa: a phase 2 randomized placebo-controlled trial","author":"Hemmerling","year":"2024","journal-title":"Lancet Microbe"},{"key":"B21","doi-asserted-by":"publisher","first-page":"415","DOI":"10.1016\/j.clinthera.2023.04.001","article-title":"Acceptability of single-dose clindamycin gel for bacterial vaginosis: a randomized controlled trial","volume":"45","author":"Mauck","year":"2023","journal-title":"Clin Ther"},{"key":"B22","doi-asserted-by":"publisher","first-page":"1053","DOI":"10.1089\/jwh.2006.15.1053","article-title":"Women\u2019s satisfaction with an intravaginal Lactobacillus capsule for the treatment of bacterial vaginosis","volume":"15","author":"Marrazzo","year":"2006","journal-title":"J Womens Health (Larchmt)"},{"key":"B23","doi-asserted-by":"publisher","first-page":"799963","DOI":"10.3389\/fgwh.2021.799963","article-title":"Acceptability and satisfaction of contraceptive vaginal rings in clinical studies: a systematic review and narrative synthesis","volume":"2","author":"Delvaux","year":"2021","journal-title":"Front Glob Womens Health"},{"key":"B24","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1016\/j.contraception.2021.10.001","article-title":"Vaginal ring acceptability: a systematic review and meta-analysis of vaginal ring experiences from around the world","volume":"106","author":"Ridgeway","year":"2022","journal-title":"Contraception"},{"key":"B25","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1007\/s10461-024-04529-2","article-title":"HIV Prevention product acceptability and preference among women in sub-Saharan Africa to inform novel biomedical options in development: a systematic review","volume":"29","author":"Makoni","year":"2025","journal-title":"AIDS Behav"},{"key":"B26","doi-asserted-by":"publisher","first-page":"3615","DOI":"10.1007\/s10461-024-04421-z","article-title":"Acceptability of the dapivirine vaginal ring and daily oral pre-exposure prophylaxis (PrEP) during pregnancy in Malawi, South Africa, Uganda, and Zimbabwe","volume":"28","author":"Young","year":"2024","journal-title":"AIDS Behav"}],"container-title":["Frontiers in Reproductive Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/frph.2025.1544458\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,26]],"date-time":"2025-03-26T14:14:33Z","timestamp":1742998473000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/frph.2025.1544458\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,25]]},"references-count":26,"alternative-id":["10.3389\/frph.2025.1544458"],"URL":"https:\/\/doi.org\/10.3389\/frph.2025.1544458","relation":{},"ISSN":["2673-3153"],"issn-type":[{"value":"2673-3153","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,25]]},"article-number":"1544458"}}