{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T23:09:46Z","timestamp":1777072186650,"version":"3.51.4"},"reference-count":28,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,12,26]],"date-time":"2024-12-26T00:00:00Z","timestamp":1735171200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl J Gynecology &amp; Obste"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To determine the safety, tolerance, and adherence to self\u2010administered intravaginal 5% fluorouracil (5FU) cream as adjuvant therapy following cervical intraepithelial neoplasia grade 2 or 3 (CIN2\/3) treatment among women living with HIV (WLWH) in Kenya.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A phase I pilot trial was performed among 12 WLWH in Kenya, aged 18\u201349\u2009years between March 2023 and February 2024 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05362955?term=chemtai mungo&amp;rank=1\">ClinicalTrial.gov NCT05362955<\/jats:ext-link>\n                      ). Participants self\u2010administered 2\u2009g of 5FU intravaginally every other week for eight applications. Safety was assessed using a standardized grading scale, and adherence was evaluated using self\u2010report, inspection of used applicators, and weighing of the study drug.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The mean age and CD4 count were 43.9\u2009years and 781 cells\/mm\n                      <jats:sup>3<\/jats:sup>\n                      , respectively. Seven (58%) had an eighth\u2010grade education or less. All 12 reported at least one grade I adverse event (AE), one (8%) reported a grade 2 AE, no grade 3 or 4 AEs were reported. Increased vaginal discharge (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20099, 75%) and irritation (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095, 42%), with a mean duration of 3.2 and 2.8\u2009days, respectively, were the most commonly reported AEs. Provider\u2010observed AEs included grade 1 cervical erythema and superficial abrasions. All participants tolerated all eight 5FU doses, and 96% adherence was demonstrated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Self\u2010administered 5FU following CIN2\/3 treatment among WLWH in Kisumu, Kenya, was safe, tolerable, and associated with high adherence. Randomized trials are needed to investigate whether adjuvant 5FU can improve treatment outcomes or serve as primary cervical precancer treatment in sub\u2010Saharan Africa. A self\u2010administered therapy may be transformative in increasing access to treatment and, hence, secondary prevention of cervical cancer.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ijgo.16093","type":"journal-article","created":{"date-parts":[[2024,12,26]],"date-time":"2024-12-26T06:16:33Z","timestamp":1735193793000},"page":"781-787","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Safety and adherence to self\u2010administered intravaginal 5\u2010fluorouracil cream following cervical intraepithelial neoplasia (\n                    <scp>CIN<\/scp>\n                    ) 2\/3 treatment among\n                    <scp>HIV<\/scp>\n                    \u2010positive women in Kenya: A phase 1 clinical trial"],"prefix":"10.1002","volume":"169","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3655-4721","authenticated-orcid":false,"given":"Chemtai","family":"Mungo","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology University of North Carolina\u2010Chapel Hill  Chapel Hill North Carolina USA"},{"name":"Lineberger Comprehensive Cancer Center University of North Carolina\u2010Chapel Hill  Chapel Hill North Carolina USA"},{"name":"Center for AIDS Research University of North Carolina\u2010Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jackton","family":"Omoto","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Maseno University School of Medicine  Maseno Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cirilus","family":"Ogollah","sequence":"additional","affiliation":[{"name":"Center for Microbiology Research Kenya Medical Research Institute  Kisumu Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antony","family":"Owaya","sequence":"additional","affiliation":[{"name":"Center for Microbiology Research Kenya Medical Research Institute  Kisumu Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mercy","family":"Rop","sequence":"additional","affiliation":[{"name":"Center for Microbiology Research Kenya Medical Research Institute  Kisumu Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gershon","family":"Rota","sequence":"additional","affiliation":[{"name":"Center for Microbiology Research Kenya Medical Research Institute  Kisumu Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth A.","family":"Bukusi","sequence":"additional","affiliation":[{"name":"Center for Microbiology Research Kenya Medical Research Institute  Kisumu Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer H.","family":"Tang","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology University of North Carolina\u2010Chapel Hill  Chapel Hill North Carolina USA"},{"name":"Lineberger Comprehensive Cancer Center University of North Carolina\u2010Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Rahangdale","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology University of North Carolina\u2010Chapel Hill  Chapel Hill North Carolina USA"},{"name":"Lineberger Comprehensive Cancer Center University of North Carolina\u2010Chapel Hill  Chapel Hill North Carolina USA"},{"name":"Center for AIDS Research University of North Carolina\u2010Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,12,26]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/CAAC.21660"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0956462413491735"},{"key":"e_1_2_9_4_1","unstructured":"WHO.A Global Strategy for elimination of cervical cancer. 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